Evidence-Based Review Articles for Shockwave Lithotripsy Practice

Explore clinically focused review articles designed to help physicians refine patient selection, understand risk factors, optimise SWL protocols, and apply evidence-based decision-making in daily stone management.

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ESWL in the Cardiac Patient

Pacemakers, ICDs, Arrhythmias, and the ECG-Gating Imperative
Author: Sameer Parmar

Abstract

Background: The cardiac patient presenting for extracorporeal shock wave lithotripsy (ESWL) encompasses several clinically distinct profiles — those with permanent pacemakers (PPM), implantable cardioverter-defibrillators (ICDs), cardiac resynchronization therapy devices (CRT-P/CRT-D), atrial fibrillation, and other pre-existing arrhythmias. Despite a coherent and substantial body of evidence permitting evidence-based management of virtually every cardiac device scenario, clinical practice remains heterogeneous across ESWL centres. Shock waves interact with cardiac physiology and implanted devices through two distinct mechanisms: mechanoelectrical stimulation of the myocardium — responsible for ESWL-induced arrhythmias — and electromagnetic interference with device circuitry, which can cause pacemaker inhibition or, critically, inappropriate ICD shock delivery.

Objectives: This article provides a comprehensive, evidence-based framework for the management of ESWL across all major cardiac patient categories. It addresses the physics of shock wave-device interaction, the arrhythmogenic mechanisms of ESWL in both device-bearing and device-free patients, the clinical evidence base for each device type, mandatory multidisciplinary pre-procedure requirements, and a practical intraoperative and post-procedure protocol applicable to urological practice.

Methods: A structured narrative review was conducted incorporating landmark in-vitro and clinical studies, multinational surveys, population-based treatment series, regulatory guidance documents, and consensus statements from electrophysiology. Key sources include the foundational Cooper et al. pacemaker classification study (PACE 1988; PMID: 2462246), the Drach, Weber, and Donovan multinational survey of 131 pacemaker patients across 98 ESWL centres (J Urol 1990), the Vassolas ICD bench-testing study (PACE 1993; PMID: 7686653), the Platonov evidence-based guidelines for the modern device era (PACE 2008; PMID: 18294028), a prospective cohort of 342 patients examining arrhythmia predictors (Thomas et al., PMC3328549), and FDA regulatory guidance for lithotripter 510(k) submissions governing cardiac monitoring and device management requirements.
Results: Unsynchronized ESWL produces arrhythmias in 60–80% of patients with early electrohydraulic lithotripters; ECG-gated R-wave triggered delivery reduces this to 11–59%, with the residual events being predominantly benign unifocal premature ventricular contractions (PVCs). Ganem and Carson’s retrospective data quantify a 20-fold reduction in arrhythmia incidence with gating. Pacemakers are not an absolute contraindication to ESWL: the Cooper classification demonstrates that single-chamber VVI pacemakers can be treated safely without reprogramming, dual-chamber DDD devices require reprogramming to VVI mode, and rate-responsive devices with piezoelectric crystal sensors carry the highest risk due to physical sensor damage at the focal zone. The Drach multinational survey of 131 patients documented a 3.1% device-related complication rate — none lethal, all corrected immediately. For ICDs, tachytherapy must be deactivated before ESWL, as oversensing of shock wave electromagnetic noise can trigger inappropriate defibrillation shocks; bench testing by Vassolas confirmed no ICD internal damage after standard ESWL and endorsed the feasibility of contralateral treatment. Atrial fibrillation, while creating technical challenges for R-wave gating, is not a contraindication: series of 48 cases with irregular cardiac rhythms and a separate Romanian cohort both demonstrated clinical safety under cardiologist supervision. Abdominal pacemaker implantation represents a distinct high-risk scenario where ESWL is relatively-to-absolutely contraindicated if the focal zone cannot be maintained ≥5 cm from the pulse generator. A case of STEMI during ECG-gated ESWL underscores that catastrophic cardiac events, while rare, remain possible and mandate continuous 12-lead ECG monitoring with cardiac-trained staff at all sessions.

Conclusions: ESWL is feasible in the majority of cardiac patients — including those with pacemakers and ICDs — when a structured, device-specific management protocol is applied. The four non-negotiable pillars of safe practice are: (1) continuous ECG monitoring throughout every ESWL procedure, as mandated by FDA guidance; (2) ECG-gated shock delivery for all patients with cardiac history or implanted devices; (3) formal pre-procedure and post-procedure electrophysiology or device clinic involvement for all device-bearing patients; and (4) an external defibrillator immediately available whenever ICD tachytherapy is deactivated. The treating urologist must not act unilaterally — every cardiac device patient demands multidisciplinary collaboration. A practical device-specific protocol and decision matrix for all cardiac patient categories are presented.

Introduction

Of all the special-population scenarios encountered in lithotripsy practice, the cardiac patient with an implanted electronic device is perhaps the one that generates the most anxiety — and the most inconsistency in clinical practice. A survey of 141 ESWL centers across the United States and 55 in Europe by Drach, Weber, and Donovan (Journal of Urology, 1990) found that treatment practices for pacemaker patients varied dramatically between institutions: some centers categorically refused treatment, others proceeded without any modification, and most occupied an uncertain middle ground with informal, undocumented protocols. This heterogeneity persists to this day, despite a substantial and coherent body of evidence that, when properly synthesized, permits evidence-based management of virtually every cardiac device scenario encountered in urological practice.

The cardiac patient presenting for ESWL encompasses several distinct clinical profiles: the patient with a permanent cardiac pacemaker (PPM) for bradyarrhythmia or heart block; the patient with an implantable cardioverter-defibrillator (ICD) for ventricular tachyarrhythmia prevention; the patient with a cardiac resynchronization therapy device (CRT-P or CRT-D) for heart failure with conduction disease; the patient with a history of cardiac arrhythmia without an implanted device; and the patient with atrial fibrillation — a rhythm whose prevalence is particularly high in the stone-forming demographic. Each profile demands a distinct, device-specific approach.

This article provides a comprehensive, evidence-based framework for managing ESWL in each of these patient categories. The physics of shock wave-device interaction, the arrhythmogenic mechanisms of ESWL, the clinical evidence base for each device type, the mandatory pre-procedure multidisciplinary requirements, and a practical intraoperative protocol are all addressed in detail.

How Shock Waves Interact with Cardiac Tissue and Implanted Devices

1.1 The Two Mechanisms of Interaction

Shock waves interact with cardiac physiology and implanted devices through two fundamentally different mechanisms, and it is essential to distinguish them clearly, because they demand different management strategies:

Mechanism 1 — Mechanoelectrical stimulation of the myocardium: Shock waves are pressure waves that, when they pass through or near cardiac tissue, can mechanically stimulate cardiomyocytes. This mechanoelectrical coupling — mediated through stretch-activated ion channels that depolarize in response to mechanical deformation — can generate ectopic electrical activity. This is the mechanism responsible for ESWL-induced arrhythmias in patients without implanted devices and is the reason that arrhythmias were described in the very earliest clinical lithotripsy series, before implantable devices were a consideration. Critically, this mechanism is almost entirely preventable by ECG-gating: delivering shock waves only during the cardiac refractory period (immediately after the R-wave on ECG) ensures that no shock wave arrives during the vulnerable period of the cardiac cycle (the T-wave, corresponding to relative refractoriness) when a mechanical stimulus could trigger ventricular fibrillation.

Mechanism 2 — Electromagnetic interference with implanted device circuitry: Shock wave generators — particularly electrohydraulic (spark-gap) lithotripters — produce an electromagnetic field pulse with each shock wave discharge. This electromagnetic pulse can be sensed by the leads of implanted pacemakers or ICDs, potentially being misinterpreted as intrinsic cardiac electrical activity (oversensing). The consequences of oversensing differ critically between pacemakers and ICDs: in a pacemaker, oversensing typically causes inappropriate inhibition of pacing — a potentially dangerous outcome in a pacemaker-dependent patient; in an ICD, oversensing may trigger inappropriate shock delivery — a highly distressing and potentially harmful event. Additionally, the mechanical energy of shock waves can physically damage certain device components — particularly piezoelectric crystal activity sensors in rate-responsive pacemakers — when the device is placed at or very close to the shock wave focal zone.

1.2 Arrhythmia Incidence in the General ESWL Population

Even in patients without cardiac devices or pre-existing arrhythmias, ESWL carries a measurable risk of inducing transient cardiac dysrhythmias. Understanding this baseline is essential context for managing the patient with cardiac disease.

The reported incidence of arrhythmias varies substantially with lithotripter technology and whether ECG gating is employed: with unsynchronized ESWL, arrhythmia rates of 60–80% were reported with early electrohydraulic lithotripters such as the original Dornier HM3. With the introduction of ECG-gated (R-wave triggered) shock delivery — which fires each shock wave only milliseconds after the R-wave, during the cardiac refractory period — this rate fell to 11–59% for electromagnetic lithotripters. With fully synchronized delivery, the arrhythmias that still occur are overwhelmingly unifocal premature ventricular contractions (PVCs), which are clinically benign and do not require intervention.

A landmark prospective study of cardiac dysrhythmias by Zeng, Lindstedt, and Roijer in Swedish patients receiving ESWL found that one or more atrial and/or ventricular ectopic beats occurred in 30% of patients during piezoelectric lithotripsy (EDAP LT01), even though this generator type was long considered non-arrhythmogenic. One patient in this 50-person series experienced multifocal ventricular premature beats with ventricular bigeminy; one patient experienced cardiac arrest lasting 13.5 seconds. The authors concluded that arrhythmias can occur with piezoelectric generators and that monitoring is prudent even with these devices.

A large prospective cohort study of 342 patients undergoing ESWL at 120 shocks/minute (Thomas et al., PMC3328549) identified 4.7% with significant cardiac dysrhythmias requiring conversion to ECG-gated delivery. The dysrhythmias consisted of frequent bigeminy, trigeminy, and multifocal PVCs. All resolved promptly upon switching to ECG-gating. No other interventions were necessary and no acute side effects were observed. Importantly, younger age and right-sided treatment (proximity of the liver and right heart border to the right kidney) were the only statistically significant predictors of arrhythmia — not age, pre-existing heart disease, or anesthesia type.

The FDA, in its guidance document for lithotripter 510(k) submissions, mandates: “Cardiac monitoring: Always perform cardiac monitoring during lithotripsy treatment, since the use of extracorporeal shock wave lithotripsy has been reported to cause ventricular cardiac arrhythmias in some individuals.” This FDA requirement — inviolable for all commercially approved lithotripsy systems in the United States — applies to every patient, not just those with known cardiac disease.

ESWL in Patients with Permanent Pacemakers

2.1 Historical Context: From Contraindication to Cautious Permission

When ESWL was first introduced clinically, the presence of a permanent pacemaker was listed as an absolute contraindication in most institutional and manufacturer protocols. The early experience was based on first-generation Dornier HM3 electrohydraulic lithotripters, which produced intense electromagnetic discharges with each shock wave. By the late 1980s, however, carefully designed in vitro and clinical studies began to redefine this position, providing the evidence base that guides modern practice.

The foundational study was conducted by Cooper, Weintraub, and Plumb from the University of Alabama, published in Pacing and Clinical Electrophysiology (PACE, 1988; PMID: 2462246). This study tested 15 pacemakers — five standard single-chamber (VVI), six dual-chamber (DDD), and four rate-responsive single-chamber (Activitrax piezoelectric activity-sensing) devices — in a rigorous in vitro protocol at the focal point F2 of the Dornier HM3 lithotriptor, receiving a mean of 1,300 pressure shocks. All units were assessed by pacing system analyzer before and after, with comprehensive destructive analysis. The findings established the foundational classification still used today:

Cooper et al. 1988 — The Landmark Classification (PMID: 2462246)

  • (A) Single-chamber ventricular pacemakers (VVI mode): Safe to proceed without mode modification. The pacing stimulus triggered ESWL delivery without pacemaker malfunction.
  • (B) Dual-chamber pacemakers (DDD mode): Atrial pacing events caused inhibition of ventricular output in 2 of 6 devices. These patients should be reprogrammed to VVI single-chamber mode before ESWL.
  • (C) Rate-responsive pacemakers with piezoelectric activity sensors (e.g., Activitrax): The piezoelectric sensor crystal was physically shattered at F2. Units placed 5 cm from F2 were driven to their maximum programmed pacing rate. These devices must have the rate-responsive feature deactivated before ESWL; abdominal-location devices should probably not undergo ESWL.
  • Post-study clinical validation: 6 patients with thoracically implanted pacemakers (5 VVI, 1 DDD) underwent ESWL successfully without pacemaker malfunction or arrhythmic events.

2.2 The 20-Patient Clinical Series — Oklahoma Lithotripsy Center

The Oklahoma Lithotripsy Center series by Albers et al. (Journal of Endourology, 1995; PMID: 8535456) reported 20 patients with various pacemaker types treated successfully with SWL. No significant cardiovascular events occurred during treatment across all 20 cases. The authors codified practical requirements that remain the clinical standard: cardiologist evaluation pre-procedure; reprogramming of dual-chamber devices to single-chamber VVI mode; reprogramming of rate-responsive devices to non-rate-responsive mode; ensuring the pacemaker generator is at least 5 cm from the blast path (focal zone); and careful monitoring throughout. They concluded that with these precautions, SWL can be performed safely in most pacemaker patients.

2.3 The Continental Survey — Drach, Weber, and Donovan

Drach, Weber, and Donovan’s multinational survey of pacemaker patients treated with ESWL (Journal of Urology, 1990; PMID reported as J Urol 1990;143:895) collated data from 81 US and 17 European ESWL centers. Across all responding sites, 131 patients received 142 treatments. Pacemaker-related complications occurred in 4 patients (3.1%) — none were lethal; three were minor and all were corrected immediately; no patient required replacement of the pacemaker. Critically, no correlation was found between complications and pacemaker type or manufacturer — suggesting that the risk lies in technique (proximity to focal zone, mode programming) rather than in device brand or generation.

2.4 The Modern Era — Improved Device Shielding and the Platonov Evidence-Based Guidelines

The most comprehensive and clinically relevant synthesis of modern-era pacemaker and ICD data was published by Platonov, Bhargava, and Gillis from the University of Calgary in PACE — Pacing and Clinical Electrophysiology (2008; PMID: 18294028), titled “Pacemakers, Implantable Cardioverter/Defibrillators, and Extracorporeal Shockwave Lithotripsy: Evidence-based Guidelines for the Modern Era.” This article reviewed all available evidence and specifically addressed the advances in both SWL energy delivery technology (electromagnetic devices replacing electrohydraulic generators; reduced peak pressures) and device shielding technology (titanium casing, enhanced filtering circuits, oversensing discrimination algorithms in modern CMOS-circuit devices). The authors concluded that:

  • Modern electromagnetic lithotripters produce substantially less electromagnetic interference than first-generation electrohydraulic lithotripters, improving the safety profile considerably.
  • SWL-induced inappropriate pacing suppression (oversensing causing inhibition) is demonstrably less common with modern pacemakers equipped with CMOS circuitry and titanium shielding.
  • The practice guidelines constructed from this evidence are substantially less restrictive than historical protocols — most pacemaker patients can be treated safely with appropriate pre-procedure programming and monitoring.
  • In the absence of national consensus guidelines, manufacturer-specific recommendations remain non-uniform; the evidence-based framework provided by the Calgary group fills this gap.

The authors also note that backup safety mode reversion — where a pacemaker reverts to an asynchronous safety pacing mode (VOO/AOO/DOO) in response to electromagnetic disturbance — has been reported as case reports after ESWL, but these events remain extremely rare with modern devices. The safety mode is itself a protective mechanism, not a failure, and typically self-resolves.

2.5 Pacemaker Location — The Abdominal Implant Special Case

The vast majority of modern pacemakers are implanted in the pectoral region, with leads traversing the subclavian vein to the right heart. However, a small but clinically important subset of patients — particularly those with prior cardiac surgery, vascular access complications, or historical implants — have abdominally implanted pacemakers. The clinical significance is clear from the Cooper data: the physical proximity of an abdominal generator to the shock wave focal zone during treatment of renal or ureteric stones creates a risk profile categorically different from the thoracic implant scenario. An abdominal pacemaker may lie within or very close to the shock wave beam path, risking direct physical damage to the pulse generator and leads. The case report by Asroff, Kingston, and Stein (Journal of Endourology, 1993; PMID: 8358412) documents successful ESWL in a patient with an abdominally placed pacemaker through meticulous stone targeting away from the generator location — but this represents an exceptional case requiring case-by-case electrophysiology consultation, not a generalizable protocol.

Abdominal Pacemaker — Special Warning

  • Abdominal pacemaker implantation is a relative-to-absolute contraindication to ESWL, depending on the stone location and the distance between the generator and the proposed focal zone.
  • If stone location would require focusing shock waves within 5 cm of an abdominally implanted pulse generator, ESWL is contraindicated — ureteroscopy or PCNL is the treatment of choice.
  • Any consideration of ESWL in a patient with an abdominal pacemaker requires individual electrophysiology and device manufacturer consultation before proceeding.
  • Pre-procedure imaging (CT or fluoroscopy) to precisely localize the generator relative to the proposed focal zone is mandatory.

ESWL in Patients with Implantable Cardioverter-Defibrillators (ICDs)

3.1 Why ICDs Are the Higher-Risk Device

The ICD differs from the pacemaker in one critically important respect for ESWL management: while pacemaker oversensing typically causes inhibition of pacing (a dangerous outcome primarily in pacemaker-dependent patients), ICD oversensing of shock wave-generated electromagnetic noise can trigger inappropriate defibrillation shock delivery — a 25–40 joule discharge delivered to the patient’s myocardium without any true arrhythmia being present. Inappropriate ICD shocks are not merely uncomfortable (though they are intensely painful and distressing to patients, described as being hit in the chest by a fist); they carry real clinical risks: they can precipitate true ventricular arrhythmias through the R-on-T phenomenon, cause myocardial injury with repeated delivery, induce extreme patient anxiety and reduce quality of life, and have been associated with increased mortality in several device registry studies.

Additionally, if an ICD interprets shock wave-generated electromagnetic signals as ventricular fibrillation and delivers an inappropriate shock, it may — in rare circumstances — precipitate the very arrhythmia it is intended to treat. The management imperative is therefore deactivation of the ICD’s tachytherapy functions before ESWL, with continuous external cardiac monitoring and an external defibrillator immediately available throughout the procedure.

3.2 The Vassolas In-Vitro Study — ICD Bench Testing

The definitive in-vitro evidence on ICD behavior during ESWL was provided by Vassolas, Roth, and Venditti (PACE, 1993; PMID: 7686653). Ten ICD devices were subjected to a full course of ESWL and then returned to the manufacturer for bench analysis. No abnormalities in function were found in any of the 10 devices after standard ESWL. One device was deliberately placed directly in the pathway of the shock wave at the focal point — it discharged (activated its defibrillation output) in response to the electromagnetic energy, but manufacturer analysis of this device also revealed no internal damage. The authors concluded: contralateral ESWL is not contraindicated for the patient with an ICD, though they recommended post-procedure device evaluation to confirm appropriate function.

The critical qualifier from this study is “contralateral” — meaning that when the stone is on the opposite side from the ICD pulse generator (most ICDs are implanted in the left pectoral region; right renal stones therefore pose less risk than left renal stones). The distinction between ipsilateral and contralateral ESWL relative to ICD implant location remains clinically important.

3.3 The FDA Mandate for ICD Management

The FDA guidance document for lithotripter 510(k) submissions provides explicit direction on ICD management, representing the regulatory standard for all FDA-cleared lithotripsy devices in the United States:

“To reduce the incidence of malfunction to a pacemaker or implantable defibrillator, the pulse generator should be programmed to a single chamber, non-rate-responsive mode (pacemakers) or an inactive mode (implantable defibrillators) prior to lithotripsy, and evaluated for proper function post-treatment. Do not focus the lithotripter’s shock wave through or near the pulse generator.”

This FDA mandate operationalizes into two absolute requirements: (1) ICD tachytherapy must be deactivated before ESWL; (2) the shock wave focal zone must not pass through or near the pulse generator. Both requirements demand electrophysiology or device clinic involvement before the procedure and post-procedure device interrogation.

Boston Scientific’s formal technical guidance document (2008) for its cardiac rhythm management devices states explicitly that the company cannot assure the safe and effective operation of its implantable CRM device and lithotripsy equipment when used in combination, and that patients and their renal specialist should consult the attending cardiologist or electrophysiologist before proceeding. This manufacturer caveat is representative of the policy of all major ICD manufacturers.

3.4 CRT Devices (CRT-P and CRT-D)

Cardiac resynchronization therapy devices — biventricular pacemakers (CRT-P) or biventricular pacemaker-defibrillators (CRT-D) — represent the most complex implanted cardiac device category encountered in ESWL practice. These devices have three or four leads (right atrial, right ventricular, left ventricular via the coronary sinus, and sometimes a defibrillation coil lead), complex pacing algorithms with atrial sensing and biventricular timing, and in the case of CRT-D, ICD functionality. For ESWL purposes:

  • The device should be treated as an ICD if it contains defibrillation capability (CRT-D) — tachytherapy must be deactivated.
  • The biventricular pacing mode cannot simply be reprogrammed to VVI as in a conventional dual-chamber pacemaker — doing so may lead to suboptimal hemodynamics in a patient with heart failure and reduced ejection fraction. Electrophysiology consultation is mandatory to determine the optimal pacing mode during ESWL while preserving hemodynamic stability.
  • CRT patients typically have significant structural heart disease — their underlying cardiac reserve must be formally assessed before any procedure.
  • Post-procedure device interrogation must confirm preservation of all three lead functions and appropriate resynchronization parameters.

ESWL in Patients with Cardiac Arrhythmias (No Implanted Device)

4.1 Atrial Fibrillation

Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia encountered in clinical practice, with a prevalence that increases sharply with age — precisely the demographic most likely to present with urolithiasis. AF poses a specific technical challenge for ESWL: standard ECG gating relies on R-wave detection to trigger shock wave delivery during the cardiac refractory period. In AF, the R-R interval is irregular and unpredictable, meaning R-wave triggered gating will fire shock waves at irregular intervals. The practical consequences are: (1) treatment sessions are prolonged due to the variable R-R interval reducing effective shock delivery rate; (2) the shock wave may occasionally fall outside the intended refractory period window if the beat-to-beat variation is extreme.

The evidence on treating AF patients with ESWL, while not from large RCTs, is reassuring. A retrospective series from the University of Western Ontario (Ghiculete et al., published in Journal of Endourology) evaluated 3,289 ESWL treatments over a decade. Of these, 48 treatments were performed in patients with irregular cardiac rhythms — including 10 with atrial fibrillation, 11 with bundle branch block, 6 with slow heart rate, and 21 with irregular cardiac complexes. All 48 cases were clinically insignificant — no major cardiac events occurred. When cardiac rhythm was so irregular that gated delivery was not feasible, an ungated cardiac simulator set at 85 shocks/minute for irregular rhythms (versus 120/min for elective ungated use) was employed. One patient had a clinically significant arrhythmia that resolved with reintroduction of gating.

A similar experience was reported from the Iasi Urological Department (Romania; PMID: 17802943), where patients with chronic atrial fibrillation, supraventricular arrhythmias, and ventricular ectopy underwent ESWL using a lithotriptor without an ECG triggering system, under strict cardiologic supervision. No major incidents occurred across the series, and no patient required changes to cardiac medication. The authors emphasized that careful cardiologist monitoring — not automatic exclusion — is the appropriate response to the arrhythmic stone patient without an implanted device.

4.2 Ventricular Ectopy, Bigeminy, and Pre-existing PVCs

Patients with known ventricular ectopy or frequent PVCs represent a subgroup requiring heightened monitoring. The Platonov evidence-based guidelines note that patients with a history of cardiac arrhythmia should be treated in ECG-gated mode as a general practice — a recommendation echoed by the FDA guidance document. Ganem and Carson’s retrospective review, examining patients with pre-existing hypertension and cardiac disease alongside cardiac medications, found that of patients in the ungated group, 20% developed arrhythmias — all universally benign and resolving with conversion to gated delivery. In the gated group, only 1 of 357 patients developed any arrhythmia. The protective effect of gating is thus quantifiable: a 20-fold reduction in arrhythmia incidence.

Eaton and Erturk’s study of 51 patients undergoing ungated lithotripsy examined troponin levels at 24 hours in the 21 patients who developed more than 6 intraoperative PVCs. Troponin levels did not differ significantly from non-arrhythmia controls, suggesting that ESWL-induced ventricular ectopy reflects mechanical stimulation of the myocardium rather than true myocardial injury — an important reassurance regarding the biological significance of these events.

4.3 The Rare but Real: STEMI During ECG-Gated ESWL

While the overwhelming majority of ESWL-associated arrhythmias are benign and self-limiting, the literature contains a sobering case report that merits mention in any discussion of cardiac risk. A case published in Frontiers in Surgery (PMC10205987) describes a 45-year-old male who developed ST-elevation myocardial infarction (STEMI) during ECG-gated ESWL — the first such case reported with synchronized delivery. The patient had no pre-procedure cardiac symptoms. The STEMI was recognized by the nursing team from atypical symptoms and ECG pattern changes; emergency PCI with stent placement restored coronary flow with no complications. The authors reflect that while synchronized ESWL dramatically reduces arrhythmia incidence, rare catastrophic cardiac events can still occur, and continuous 12-lead ECG monitoring with cardiac-trained staff present remains a non-negotiable safety requirement.

A Practical Clinical Protocol for ESWL in the Cardiac Patient

5.1 Pre-Procedure Assessment — The Mandatory Multidisciplinary Framework

The single most important principle in managing the cardiac patient for ESWL is that this is not a decision the urologist makes alone. Every patient with a cardiac device or significant cardiac arrhythmia requires formal pre-procedure consultation with a cardiologist, electrophysiologist, or device clinic. This is not a courtesy referral — it is a clinical necessity that determines what protocol modifications are required, whether the device needs reprogramming, and who will perform and document post-procedure device interrogation.

Patient
Category
Pre-Procedure RequirementResponsible Party
Single-chamber VVI pacemaker (thoracic)Cardiology review; confirm VVI mode and sensitivity settings; document pacemaker model and manufacturerCardiologist /
Device clinic
Dual-chamber DDD pacemakerMandatory reprogramming to VVI single-chamber mode before ESWL; rate-responsive feature OFF if applicableElectrophysiologist / Device clinic
Rate-responsive pacemaker (any sensor type)Rate-responsive feature must be programmed OFF. Piezoelectric activity sensors: highest risk — specialist assessment required.Electrophysiologist
Abdominal pacemakerImaging to localize generator relative to stone; electrophysiology + manufacturer consultation; likely contraindicated if stone ipsilateralElectrophysiologist + Manufacturer
ICD (single or dual chamber)Tachytherapy MUST be deactivated (programmed to monitor/detection OFF mode) before ESWL; post-procedure reactivation and interrogation mandatory; external defibrillator at bedside throughoutElectrophysiologist
CRT-P device
(biventricular pacemaker)
Electrophysiology consultation for optimal pacing mode; do not simply reprogram to VVI without specialist guidanceElectrophysiologist
CRT-D deviceTreat as ICD for tachytherapy; complex mode optimization for pacing — specialist mandatoryElectrophysiologist
Atrial fibrillation (no device)Cardiology clearance; rate control optimization; plan for ECG-gated or low-rate ungated delivery; continuous ECG monitoringCardiologist
Known ventricular arrhythmia history (no device)ECG-gated mode mandatory; cardiology review if structural heart disease presentCardiologist / Urologist
No cardiac history — routine patientBaseline ECG; standard continuous ECG monitoring per FDA requirementUrologist / Anesthesiologist

5.2 Intraoperative Protocol

ParameterCardiac Patient Protocol
ECG monitoringContinuous 5-lead ECG monitoring throughout the procedure — mandatory per FDA requirement. Cardiac-trained staff (anesthesiologist or cardiologist) must interpret rhythm in real time.
ECG gatingAll patients with known arrhythmia history, cardiac devices, or AF must be treated in R-wave triggered ECG-gated mode. In patients with AF: gated mode at best-available R-detection; if R-wave recognition unreliable, cardiologist-supervised ungated mode at reduced rate (≤80/min).
External defibrillatorImmediately available and powered-on throughout all ESWL procedures. Mandatory for all ICD patients with tachytherapy deactivated. Must be available for all cardiac patients.
Shock wave rate60/min standard (reduced from 120/min) for all cardiac patients. Reduces cumulative mechanical cardiac stimulation. Further reduce to 30/min if any arrhythmia develops on monitoring.
Focal zone positioningConfirm pulse generator is ≥ 5 cm from shock wave beam path. Fluoroscopic or imaging confirmation before initiating treatment.
ICD status verificationDocument in writing that ICD tachytherapy has been deactivated by the device clinic before starting treatment. Verbal confirmation alone is insufficient.
Arrhythmia response protocolSingle PVCs: continue with monitoring. Runs of bigeminy/trigeminy: pause, assess, resume with gating if not already in use or reduce rate. Sustained arrhythmia: stop ESWL immediately, treat arrhythmia, do not resume same session.
Right-sided treatment awarenessThomas et al. and Greenstein et al. both identify right-sided treatment as a risk factor for arrhythmia. Enhanced vigilance for right renal/ureteral ESWL in any cardiac patient.
Analgesia / sedationAdequate pain control reduces catecholamine-mediated arrhythmogenesis. Anxiety-related tachycardia can interfere with ECG gating — sedation is beneficial.
Session duration limitsAvoid prolonged sessions in patients with structural heart disease. If adequate fragmentation not achieved within standard session parameters, plan repeat session rather than extending single session.

5.3 Post-Procedure Protocol

  • For ALL patients with cardiac devices: post-procedure device interrogation by the device clinic or electrophysiologist before discharge — confirm all parameters unchanged and device functioning normally.
  • For ICD patients: tachytherapy must be REACTIVATED immediately after ESWL, documented in writing, and confirmed by device interrogation. Delayed reactivation is a serious patient safety risk.
  • 12-lead ECG post-procedure in all cardiac device patients and in any patient who developed intraoperative arrhythmia.
  • Observation period: minimum 1–2 hours post-procedure cardiac monitoring for device patients. Do not discharge immediately.
  • Discharge criteria for cardiac patients: stable cardiac rhythm, device interrogation confirmed normal, blood pressure stable, no chest symptoms.
  • Discharge documentation must record: device mode pre- and post-procedure, any intraoperative arrhythmia events, name of electrophysiologist/cardiologist who performed device check.
  • Patient/family counseling: instruct to report any symptoms of palpitations, presyncope, syncope, inappropriate ICD shock sensation, or chest pain within 72 hours post-ESWL.

Device-Specific Decision Summary

Device / ConditionESWL FeasibilityKey Requirements
Single-chamber VVI pacemaker (thoracic)Generally safe — proceed with standard precautionsCardiologist review; confirm VVI mode; ≥5 cm from focal zone; ECG monitoring
Dual-chamber DDD pacemakerSafe after reprogrammingReprogram to VVI before ESWL; rate-responsive OFF; post-procedure interrogation
Rate-responsive pacemaker (accelerometer)Generally safe after feature deactivationRate-responsive feature OFF; specialist guidance; post-procedure interrogation
Rate-responsive pacemaker (piezoelectric crystal sensor)Higher risk — specialist evaluation requiredSensor feature OFF mandatory; abdominal implant: likely contraindicated; electrophysiologist mandatory
Abdominal pacemaker (any type)Relative-to-absolute contraindication depending on stone locationImaging to confirm ≥5 cm clearance; if <5 cm: redirect to URS/PCNL; manufacturer consultation
ICD — contralateral stoneFeasible with deactivation protocolTachytherapy OFF before ESWL; external defibrillator present; post-procedure reactivation + interrogation
ICD — ipsilateral stoneIncreased risk — specialist risk-benefit analysisElectrophysiologist mandatory; consider URS as alternative; if ESWL: meticulous focal zone planning
CRT-P (biventricular pacemaker)Feasible with specialist supportElectrophysiology consultation for mode optimization; do not assume VVI reprogramming is safe
CRT-D (biventricular ICD)Feasible with ICD deactivation protocolTreat as ICD for tachytherapy; complex pacing management — electrophysiologist mandatory throughout
Atrial fibrillation (no device)Feasible — gating preferred; ungated acceptable under supervisionECG-gated mode preferred; rate-controlled AF; cardiologist monitoring; reduced shock rate
Ventricular ectopy / PVCs (no device)Feasible with ECG-gated deliveryECG-gated mode; reduced shock rate; cardiology clearance for structural disease
Recent MI (< 3 months)Relative contraindicationCardiology clearance essential; myocardium may be irritable; delay if clinically possible
Wolff-Parkinson-White / accessory pathwayFeasible with electrophysiology guidanceRisk of triggering SVT via mechanical stimulation; electrophysiologist input; ECG gating

Absolute and Relative Contraindications in the Cardiac Patient

Contraindication TypeCondition
AbsoluteAbdominal pacemaker with stone requiring focal zone within 5 cm of generator
AbsoluteUncontrolled arrhythmia with hemodynamic instability — ESWL is elective; stabilize first
AbsoluteICD with tachytherapy active and no ability to deactivate pre-procedure
AbsoluteNo external defibrillator available when treating an ICD patient with deactivated tachytherapy
AbsoluteAbsence of electrophysiology consultation when required (ICD, CRT-D, abdominal PPM)
RelativeRecent MI (< 3 months) — myocardial irritability; delay if clinically feasible
RelativeSevere uncontrolled AF with rapid ventricular response — optimize rate first
RelativeICD with ipsilateral renal stone — elevated risk vs contralateral; consider URS
RelativeCRT-D patient without specialist availability for pacing optimization
RelativePacemaker-dependent patient (no intrinsic rhythm) — extreme care; VVI reprogramming mandatory; backup pacing must be confirmed functional

Key Clinical Takeaways

Summary: ESWL in the Cardiac Patient

  • Cardiac monitoring (continuous ECG) during every ESWL procedure is mandatory per FDA requirement — not optional, not reserved for cardiac patients only.
  • Shock waves cause arrhythmias in 60–80% of patients with unsynchronized delivery and 11–59% with ECG-gated delivery. ECG gating is the single most important arrhythmia prevention strategy.
  • Pacemakers are NOT an absolute contraindication to ESWL (Cooper 1988, Drach 1990, Albers 1995). The three-part classification defines safe management by device type.
  • Dual-chamber (DDD) pacemakers must be reprogrammed to VVI before ESWL. Rate-responsive features must be deactivated. (Cooper et al. PACE 1988, PMID: 2462246)
  • The pacemaker pulse generator must be ≥ 5 cm from the shock wave focal zone at all times. (Albers et al. J Endourol 1995, PMID: 8535456)
  • ICDs require tachytherapy deactivation before ESWL. An external defibrillator must be at bedside throughout. ICD must be reactivated and interrogated post-procedure before discharge. (FDA Guidance; Vassolas PACE 1993)
  • Atrial fibrillation is a management challenge, not a contraindication — ECG-gated or cardiologist-supervised ungated ESWL at reduced rate (≤85/min) is safe in AF patients. (Ghiculete 30,892-treatment series; Iasi PMID: 17802943)
  • Post-procedure device interrogation by the device clinic or electrophysiologist is mandatory for ALL pacemaker and ICD patients before discharge.
  • Abdominal pacemakers are a special high-risk scenario — pre-procedure imaging to establish generator-to-focal-zone distance is required; redirect to URS if distance is < 5 cm.
  • The treating urologist must not act alone: every cardiac device patient requires formal pre-procedure and post-procedure cardiologist or electrophysiologist involvement.

References

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  2. Drach GW, Weber C, Donovan JM. Treatment of pacemaker patients with extracorporeal shock wave lithotripsy: experience from two continents. J Urol. 1990;143(5):895–896. PMID reported J Urol 1990;143:895
  3. Albers DD, Lybrand FE 3rd, Axton JC, Albers DD Jr. Shock wave lithotripsy and pacemakers: experience with 20 cases. J Endourol. 1995;9(4):301–303. PMID: 8535456
  4. Platonov MA, Bhargava M, Gillis AM. Pacemakers, implantable cardioverter/defibrillators, and extracorporeal shockwave lithotripsy: evidence-based guidelines for the modern era. Pacing Clin Electrophysiol. 2008;31(11):1–7. doi: 10.1111/j.1540-8159.2008.01138.x. PMID: 18294028
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  8. Thomas R, Farivar M, Walmsley R, et al. Variables influencing the likelihood of cardiac dysrhythmias during extracorporeal shock wave lithotripsy. Can Urol Assoc J. 2012;6(2):87–91. PMC: PMC3328549
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  14. U.S. Food and Drug Administration. Content of Premarket Notifications (510(k)s) for Extracorporeal Shock Wave Lithotripters Indicated for the Fragmentation of Kidney and Ureteral Calculi — Guidance for Industry and FDA Reviewers. FDA Center for Devices and Radiological Health. Available at: fda.gov
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  17. American Society of Anesthesiologists Task Force on Perioperative Management of Patients with Cardiac Rhythm Management Devices. Practice Advisory. Anesthesiology. 2005;103(1):186–198. PMID: 15983472
  18. Perioperative Management of Patients with Implantable Cardioverter Defibrillators. A review. PMC: PMC2001150