MAT # 19372561
*Please see attached Procedure and OP note screenshots for reference*
On 07/17/2024, an 82yo male outpatient underwent an EP VT/PVC ablation for frequent symptomatic PVCs under general anesthesia with invasive monitoring documented (including an arterial line).
Of note: He was placed on Eliquis about 4 months earlier for a DVT. This resolved but he remained on Eliquis. Pre-op he was instructed to remain on Eliquis and not stop it at any point. During ablation procedure, heparin was administered.
Airway documentation reflects difficult intubation (video laryngoscopy; two attempts; Grade IV view). The ablation narrative describes transseptal/left-sided work with ICE + CARTO guidance, advancing an irrigated ablation catheter to the left ventricle and targeting PVC foci involving the anterolateral papillary muscle with suspected posteromedial papillary muscle involvement. Because PVCs became less frequent (attributed to sedation), isoproterenol bolus and infusion were used to provoke ectopy, and RF energy 25-30W was applied to papillary muscle regions.
The procedure note states that just prior to stopping isoproterenol and removing catheters, the pt developed an acute systolic BP drop, and ICE demonstrated a large pericardial effusion. The patient was immediately prepared for pericardiocentesis, but then developed VT degenerating to VF requiring defib and ACLS. The EP nursing log documents effusion noted 16:28 with BP dropping, attempting centesis 16:38, then loss of capture and pulselessness 16:41-16:42, with CPR initiated at 16:42 and repeated epi/cardioversions. During resuscitation, contrast at the centesis site was documented as showing “no free flowing fluid,” raising concern for clotted hemopericardium and/or inadequate pericardial access despite a “large effusion” on ICE.
ROSC was documented around 17:03 (pulse check positive; echo confirmation), followed by ongoing instability with a second CPR episode around 17:28 (loss of A-line pressure) and return of arterial pressure shortly thereafter. The patient was then transported to a hybrid OR. Surgical documentation states that a pericardial drain had been placed with continuous evacuation of blood, but bleeding persisted and did not seal, prompting emergent sternotomy and bypass.
In the OR, surgeons documented cardiac perforations involving both the right ventricle (diaphragmatic surface) and a larger perforation at the left ventricular apex. The myocardium was described as extremely friable. The RV injury was repaired; multiple attempts to repair the LV injury with buttressed sutures repeatedly failed due to tissue tearing. After discussion with family, further repair was deemed futile; bypass was stopped and the patient exsanguinated and expired.
EP SOC concerns include:
(1) technical and safety considerations of LV/papillary muscle ablation (catheter stability/contact, lesion delivery at 25–30W, and risk mitigation for perforation)
(2) timing/recognition of impending tamponade and whether earlier intervention was feasible
(3) effectiveness and timeliness of pericardiocentesis in the setting of suspected hemopericardium/clot (including whether a delay to surgical control occurred)
(4) Should patient have still been on Eliquis and if not, could the massive bleeding events have been prevented?
Thank you in advance and questions welcome.
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No questions yet!
Do you believe there might have been medical error?
Interruption of eliquis for 1 dose may have reduced the severity of bleeding. Would need to see the ablation record for specifics about safety of energy delivery (time, power, impedance) as well as fluoroscopic and intracardiac echo images to identify other structural aspects of the complication. I do not see record of what blood products were transfused (which could have limited bleeding), nor whether prothrombin complex concentrate or andexanet alpha (which was still on the market at the time) were administered. I do not see whether the patient failed medical therapy, what the symptom status was, or whether there was LV dysfunction to ascertain the strength of the procedure indication.
Do you believe there might have been causation (i.e. the medical error resulted in an injury)?
see above for a discussion about causation
What makes you a good expert for this case?
Board certified ep, performing >400 EP procedures yearly including PVC ablation
How often do you encounter cases similar to this one in your practice?
I take care of patients with PVCs and needing PVC ablation weekly.
Do you believe there might have been medical error?
In this case, the patient’s apixaban (Eliquis) had been initiated for treatment of a prior DVT that had already resolved, and there is no indication from the summary that he had an independent high-risk thromboembolic condition mandating uninterrupted anticoagulation. While uninterrupted DOAC therapy is well established and supported in atrial fibrillation ablation to reduce periprocedural stroke risk, that rationale does not directly apply to a PVC ablation performed for ventricular ectopy in a patient without active atrial thromboembolic risk. In this setting, particularly in an 82-year-old undergoing left-sided papillary muscle ablation with anticipated systemic heparinization, it would have been reasonable to consider temporary interruption of apixaban prior to the procedure. Continuing full-dose Eliquis in addition to intraprocedural heparin likely increased the severity of hemorrhage once perforation occurred. Although anticoagulation did not cause the myocardial perforation itself, the decision to proceed on uninterrupted apixaban—when it was being used for a resolved DVT rather than a compelling ongoing indication—may have materially contributed to the magnitude and uncontrollability of the bleeding event.n addition to the anticoagulation concern, several procedural and management aspects warrant scrutiny from a standard-of-care perspective. First, papillary muscle ablation in an 82-year-old patient requires heightened caution due to reduced myocardial compliance and increased tissue friability. Delivering irrigated RF energy at 25–30W in highly mobile papillary muscle regions—particularly without clearly documented contact-force monitoring, lesion duration limits, or explicit strategies to mitigate steam-pop risk—raises concern for excessive lesion depth and mechanical instability. If detailed documentation of contact parameters, impedance trends, or lesion duration is lacking, that may reflect suboptimal risk mitigation for a known high-risk substrate. Second, while ICE identified a large effusion at 16:28, the approximately 10-minute interval before attempted pericardiocentesis, followed by arrest within minutes, warrants careful review. In rapidly evolving tamponade during left-sided ablation, immediate needle access is critical. Any delay in mobilizing pericardial access equipment, confirming needle position, or escalating to surgical backup may be scrutinized. Additionally, documentation indicating “no free flowing fluid” despite a large effusion suggests either clotted hemopericardium or ineffective pericardial access. In high-risk LV ablation cases—especially in elderly anticoagulated patients—best practice often includes having surgical backup immediately available and a low threshold for expedited surgical control when drainage is ineffective. Third, the presence of both RV and LV perforations raises concern for either excessive catheter manipulation, repeated mechanical trauma, or transmural thermal injury. Multiple chamber perforations are uncommon in routine PVC ablation and may indicate technical instability or loss of catheter control. The record should be evaluated for evidence of steam pops, excessive contact force, prolonged lesion application, or repeated ablation at the same site. Finally, procedural risk–benefit assessment itself may be questioned. An 82-year-old undergoing complex left ventricular papillary muscle ablation for symptomatic PVCs (as opposed to life-threatening ventricular arrhythmia) presents a different risk tolerance profile. Careful documentation of symptom burden, failed medical therapy, and informed consent regarding the elevated perforation risk specific to papillary muscle ablation is essential. If this documentation is limited, that may represent an additional area of vulnerability. Collectively, potential standard-of-care concerns include: (1) anticoagulation management decisions, (2) lesion delivery and catheter stability safeguards in a high-risk substrate, (3) rapidity and effectiveness of tamponade management, (4) escalation to surgical intervention, and (5) procedural appropriateness and informed consent in an elderly patient undergoing complex LV ablation.
Do you believe there might have been causation (i.e. the medical error resulted in an injury)?
n addition to the anticoagulation concern, several procedural and management aspects warrant scrutiny from a standard-of-care perspective. First, papillary muscle ablation in an 82-year-old patient requires heightened caution due to reduced myocardial compliance and increased tissue friability. Delivering irrigated RF energy at 25–30W in highly mobile papillary muscle regions—particularly without clearly documented contact-force monitoring, lesion duration limits, or explicit strategies to mitigate steam-pop risk—raises concern for excessive lesion depth and mechanical instability. If detailed documentation of contact parameters, impedance trends, or lesion duration is lacking, that may reflect suboptimal risk mitigation for a known high-risk substrate. Second, while ICE identified a large effusion at 16:28, the approximately 10-minute interval before attempted pericardiocentesis, followed by arrest within minutes, warrants careful review. In rapidly evolving tamponade during left-sided ablation, immediate needle access is critical. Any delay in mobilizing pericardial access equipment, confirming needle position, or escalating to surgical backup may be scrutinized. Additionally, documentation indicating “no free flowing fluid” despite a large effusion suggests either clotted hemopericardium or ineffective pericardial access. In high-risk LV ablation cases—especially in elderly anticoagulated patients—best practice often includes having surgical backup immediately available and a low threshold for expedited surgical control when drainage is ineffective. Third, the presence of both RV and LV perforations raises concern for either excessive catheter manipulation, repeated mechanical trauma, or transmural thermal injury. Multiple-chamber perforations are uncommon during routine PVC ablation and may indicate technical instability or loss of catheter control. The record should be evaluated for evidence of steam pops, excessive contact force, prolonged lesion application, or repeated ablation at the same site. Finally, procedural risk–benefit assessment itself may be questioned. An 82-year-old undergoing complex left ventricular papillary muscle ablation for symptomatic PVCs (as opposed to life-threatening ventricular arrhythmia) presents a different risk tolerance profile. Careful documentation of symptom burden, failed medical therapy, and informed consent regarding the elevated perforation risk specific to papillary muscle ablation is essential. If this documentation is limited, it may represent an additional vulnerability. Collectively, potential standard-of-care concerns include: (1) anticoagulation management decisions, (2) lesion delivery and catheter stability safeguards in a high-risk substrate, (3) rapidity and effectiveness of tamponade management, (4) escalation to surgical intervention, and (5) procedural appropriateness and informed consent in an elderly patient undergoing complex LV ablation.
What makes you a good expert for this case?
I am board-certified in Cardiovascular Disease and Clinical Cardiac Electrophysiology and perform more than 150 complex ablations annually, including left-sided and ventricular procedures involving papillary muscle substrates. I routinely manage intraprocedural complications such as cardiac perforation and tamponade, and I have extensive experience with anticoagulation management in left-sided ablation. My active, high-volume clinical practice in complex EP procedures allows me to evaluate technical decision-making, complication recognition, and emergency response in a manner that is both current and grounded in real-world standards of care.
How often do you encounter cases similar to this one in your practice?
In my practice, I perform more than 150 ablations annually, including complex left-sided and ventricular cases such as papillary muscle and LV substrate ablation. While catastrophic perforation leading to surgical repair is rare, pericardial effusion and tamponade are recognized complications that I encounter and manage in real time as part of routine electrophysiology practice. I therefore have direct and ongoing experience with both the technical aspects of these procedures and the acute management of intraprocedural cardiac perforation.
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