Cardioverter-Defibrillator Implantation 

Updated: Jul 09, 2018
Author: Tarek Ajam, MD, MS; Chief Editor: Richard A Lange, MD, MBA 

Overview

Practice Essentials

The implantable cardioverter-defibrillator (ICD) is first-line treatment and prophylaxis for patients who are at risk of sudden cardiac death (SCD). Multiple randomized trials have consistently demonstrated ICD implantation decreases mortality in patients who have suffered cardiac arrest, those with heart failure and reduced ejection fraction, and patients with specific structural heart diseases such as hypertrophic obstructive cardiomyopathy (HOCM), sarcoidosis, and others.[1, 2, 3]

Single-chamber, dual-chamber, and biventricular ICD/lead systems (cardiac resynchronization therapy [CRT]) are available for implantation to meet different patient population needs. CRT involves pacing of the left (LV) and right ventricle (RV) (biventricular pacing). 

Current ICD/lead systems offer tiered therapy with programmable antitachycardia pacing (ATP) schemes, as well as low-energy and high-energy shocks in multiple tachycardia zones.

Advanced pacing modes and features include different activity sensor–driven rate response features. Sophisticated supraventricular tachycardia (SVT) versus ventricular tachycardia (VT) discrimination algorithms reduce the incidence of inappropriate shocks for atrial fibrillation and rapid ventricular response, sinus tachycardia, and other non–life-threatening SVTs. Diagnostic functions, including stored electrograms, allow for verification of shock appropriateness.

Technique

Incision

The skin incision is usually made in the right or left infraclavicular area, depending on the patient’s handedness. It is generally preferred that the ICD pulse generator (PG) be implanted on the opposite side of the patient’s dominant hand.

Creation of subcutaneous pocket

  • An incision 5-7 cm in length is made and carried down to the subcutaneous tissue; the dissection is extended to the prepectoral fascia with electrocauterization, blunt dissection, or both.

  • Once the incision is carried down to the prepectoral fascia, electrocautery is used to create a new plane in the inferior part of the incision with the help of an Army-Navy retractor.

  • The pocket that will accommodate the ICD PG is then created with a combination of electrodissection and blunt dissection with the fingers.

  • Once the pocket has been created and hemostasis achieved, attention is turned toward obtaining vascular access.

  • The subclavian, axillary, or cephalic veins may all be used for access; generally, a modified Seldinger technique is used under fluoroscopic or ultrasonographic guidance.

Creation of subpectoral pocket

  • For a subpectoral pocket, the author prefers, if possible, to use cephalic vein access for placement of the leads.

  • The incision is carried down to the prepectoral fascia and down to the deltopectoral groove, usually first with cautery and subsequently with blunt dissection to avoid injury to the cephalic vein.

  • The cephalic vein is then isolated and secured.

  • The lateral edge of the deltopectoral muscle is subsequently lifted and gently separated from the pectoralis minor by using blunt dissection with Metzenbaum scissors; blunt dissection with fingers may also be used at this point.

  • Once the subpectoral pocket has been created, attention is turned toward obtaining vascular access.

ICD and leads

For the majority of patients, a single-chamber ICD (with only a ventricular lead) is sufficient, especially in patients with chronic persistent atrial fibrillation. A dual-chamber ICD would be useful in patients who have indications for atrial sensing or pacing (those with sinus node disease) or to enhance the SVT versus VT discrimination enhancement by having an atrial electrogram during SVT or VT.

The high-voltage defibrillation ventricular leads may have two defibrillation coils, with the distal coil placed in the RV apex, and the more proximal coil typically extending from the junction of the high right atrium and the superior vena cava, or it may have only a single, distal defibrillation coil.

Insertion of the pulse generator

It is important to place the lead(s) in the bottom of the pocket and then to position the ICD PG in such a way that it covers the lead(s). This protects the lead(s) during any future PG change out.

In patients who require a subpectoral pocket (ie, very thin patients with minimal subcutaneous tissue), an experienced implanter should perform the operation using appropriate tools, as there is an increased risk of bleeding during the procedure.

See Technique for more detail.

Medication

Appropriate pain medication is necessary after the implantation procedure. Patients who undergo subpectoral ICD PG placement experience significantly more pain than do those who undergo subcutaneous device placement.

The evidence for postprocedural antibiotic administration is inconclusive and, for the most part, not based on randomized trials. Nevertheless, most practitioners prescribe oral antibiotics for a short period.

See Medication for more detail.

Background

Cardiovascular diseases are responsible for approximately 17.7 million deaths in the world every year,[4] with 25% from sudden cardiac death (SCD).[5]  The implantable cardioverter-defibrillator (ICD) is first-line treatment and prophylaxis for patients who are at risk of SCD. Multiple randomized trials have consistently demonstrated ICD implantation decreases mortality in patients who have suffered cardiac arrest, those with heart failure and reduced ejection fraction, and patients with specific structural heart diseases such as hypertrophic obstructive cardiomyopathy (HOCM), sarcoidosis, and others.[1, 2, 3]

Indications and techniques for ICD implantation have changed tremendously since the inception of this therapy in 1980.[6] Initially, most of the patients who received ICD therapy either showed evidence of sustained ventricular tachycardia (VT), ventricular fibrillation (VF), or they were survivors of SCD.[1, 7] At that time, thoracotomy was required for placement of epicardial defibrillation patches, and the large pulse generator (PG)/device size limited implantation sites to the upper abdomen.

The development of transvenous leads and the miniaturization of the PG allowed for pectoral placement of the defibrillator PG with a very low risk of complications. At present, most ICD placements now occur for primary prevention of SCD.[2, 3]

Indications

Indications for implantation of an implantable cardioverter-defibrillator (ICD) are established and classified on the basis of guidelines developed by the American College of Cardiology (ACC), the American Heart Association (AHA), and the Heart Rhythm Society (HRS).[8, 9, 10]

Class I indications

ICD therapy is indicated in the following:

  • Patients who are survivors of cardiac arrest due to ventricular fibrillation (VF) or hemodynamically unstable sustained ventricular tachycardia (VT) after evaluation to define the cause of the event and to exclude any completely reversible causes
  • Patients with structural heart disease and spontaneous sustained VT, whether hemodynamically stable or unstable
  • Patients with syncope of undetermined origin with clinically relevant, hemodynamically significant sustained VT or VF induced at electrophysiologic study
  • Patients with a left ventricular (LV) ejection fraction (EF) up to 35% due to prior myocardial infarction (MI) who are at least 40 days post-MI and are in New York Heart Association (NYHA) functional class II or III
  • Patients with nonischemic dilated cardiomyopathy (DCM) with an LVEF up to 35% and who are in NYHA functional class II or III 
  • ICD therapy is indicated in patients with LV dysfunction due to prior MI who are at least 40 days post-MI, have an LVEF up to 30%, and are in NYHA functional class I
  • Patients with nonsustained VT due to prior MI, an LVEF up to 40%, and inducible VF or sustained VT at electrophysiologic study

ICD implantation in pediatric patients and patients with congenital heart disease

ICD implantation is indicated in the following[9] :

  • Survivors of cardiac arrest after evaluation to define the cause of the event and to exclude any reversible causes
  • Patients with symptomatic sustained VT in association with congenital heart disease who have undergone hemodynamic and electrophysiologic evaluation; catheter ablation or surgical repair may offer possible alternatives in carefully selected patients

CRT

Cardiac resynchronization therapy (CRT) is indicated for the following:

  • (With or without an ICD) Patients with sinus rhythm, an LVEF of 35% or less, a QRS duration of 120 ms or longer, and an NYHA functional class III or ambulatory IV heart failure symptoms despite optimal medical therapy [8]
  • Patients with sinus rhythm, an LVEF of 35% or less, left bundle branch block (LBBB) with a QRS duration of at least 150 ms, and NYHA class II, III, or ambulatory IV symptoms despite optimal medical therapy [9]

Class IIa indications

ICD implantation is reasonable for patients with the following conditions[9] :

  • Unexplained syncope, significant LV dysfunction, and nonischemic DCM
  • Sustained VT and normal or near-normal ventricular function
  • Hypertrophic cardiomyopathy (HCM) who have one or more major risk factors for sudden cardiac death (SCD)
  • Prevention of SCD in patients with arrhythmogenic right ventricular dysplasia or cardiomyopathy (ARVD/C) who have one or more risk factors for SCD (sustained VT, unexplained syncope, frequent  nonsustained VT [NSVT], family history of SCD, extensive right ventricular [RV] disease, marked QRS prolongation, late gadolinium enhancement on cardiovascular magnetic resonance imaging [CMRI], LV dysfunction and VT induction during electrophysiology study) [11, 12]
  • To reduce SCD in patients with long-QT syndrome (LQTS) who are experiencing syncope or VT while receiving beta blockers
  • Non-hospitalized patients awaiting transplantation
  • Brugada syndrome who have had syncope
  • Brugada syndrome who have documented VT that has not resulted in cardiac arrest
  • Catecholaminergic polymorphic VT who have syncope and/or documented sustained VT while receiving beta blockers
  • Cardiac sarcoidosis, giant cell myocarditis, or Chagas disease

ICD implantation in pediatric patients and patients with congenital heart disease

ICD implantation is reasonable for patients with congenital heart disease with recurrent syncope of undetermined origin in the presence of either ventricular dysfunction or inducible ventricular arrhythmias at electrophysiologic study.[9]

CRT

CRT can be useful for patients who have the following conditions[9] :

  • An LVEF up to 35%, sinus rhythm, LBBB with a QRS duration of 120-149 ms, and NYHA class II, III, or ambulatory IV symptoms on guideline-directed medical therapy (GDMT)
  • An LVEF up to 35%, sinus rhythm, a non-LBBB pattern with a QRS duration of at least 150 ms, and NYHA class III/ambulatory class IV symptoms on GDMT
  • Atrial fibrillation and an LVEF up to 35% on GDMT if a) the patient requires ventricular pacing or otherwise meets CRT criteria and b) atrioventricular (AV) nodal ablation or pharmacologic rate control will allow near 100% ventricular pacing with CRT
  • On GDMT, with an LVEF up to 35% and undergoing new or replacement device placement with anticipated requirement for significant (>40%) ventricular pacing

Class IIb indications

ICD therapy may be considered in patients with the following[9]

  • Nonischemic heart disease who are in NYHA functional class I with a persistent LVEF up to 35%
  • LQTS and risk factors for SCD
  • Syncope and advanced structural heart disease in whom a thorough invasive and noninvasive investigations have failed to define a cause
  • A familial cardiomyopathy associated with sudden death
  • LV noncompaction

ICD implantation in pediatric patients and patients with congenital heart disease

ICD therapy may be considered for patients with recurrent syncope associated with complex congenital heart disease and advanced systemic ventricular dysfunction when thorough invasive and noninvasive investigations have failed to define a cause.[9]

CRT

CRT may be considered for patients who have the following[9] :

  • An LVEF up to 30%, an ischemic heart failure etiology, sinus rhythm, LBBB with a QRS duration of at least 150 ms, and an NYHA class I symptoms on GDMT
  • An LVEF up to 35%, sinus rhythm, a non-LBBB pattern with a QRS duration of 120-149 ms, and an NYHA class III/ambulatory class IV on GDMT
  • An LVEF up to 35%, sinus rhythm, a non-LBBB pattern with a QRS duration of at least 150 ms, and NYHA class II symptoms on GDMT

Class III indications

The following class III ICD indications apply to adults as well as pediatric patients and those with congenital heart diseases; ICD implantation is not indicated in these groups.

ICD therapy is not indicated for patients with the following[9] :

  • No reasonable expectation of survival with an acceptable functional status for at least 1 year, even if they meet ICD implantation criteria specified in the class I, IIa, and IIb recommendations above
  • Incessant VT or VF
  • Significant psychiatric illnesses that may be aggravated by device implantation or that may preclude systematic follow-up
  • NYHA class IV status with drug-refractory congestive heart failure (CHF) who are not candidates for cardiac transplantation or implantation of a CRT device that incorporates both pacing and defibrillation capabilities
  • Syncope of undetermined cause in the setting of absence of inducible ventricular tachyarrhythmias and without structural heart disease
  • VF or VT that is amenable to surgical or catheter ablation (eg, atrial arrhythmias associated with Wolff-Parkinson-White [WPW] syndrome, RV or LV outflow tract VT, idiopathic VT, or fascicular VT in the absence of structural heart disease)
  • Ventricular tachyarrhythmias due to a completely reversible disorder in the absence of structural heart disease (eg, electrolyte imbalance, drugs, or trauma)

Available evidence suggests that ICD implantation can be safely accomplished in patients who are anticoagulated with warfarin with a therapeutic international normalized ratio (INR) in the range of 2 to 3.[13]

CRT

The following are class III indications ("no benefit") for CRT[9] :

  • CRT is not recommended for patients with NYHA class I or II symptoms and non-LBBB pattern with a QRS duration less than 150 ms.
  • CRT is not indicated for patients whose comorbidities and/or frailty limit survival with good functional capacity to less than 1 year.

Contraindications

Implantable cardioverter-defibrillator (ICDs) are contraindicated in patients experiencing tachyarrhythmias with reversible or transient causes including, but not limited to, the following:

  • Acute myocardial infarction
  • Drug intoxication
  • Drowning
  • Electric shock
  • Electrolyte imbalance
  • Hypoxia, or sepsis
  • Patients who have a unipolar pacemaker implanted
  • Patients with incessant ventricular tachycardia (VT) or ventricular fibrillation (VF)
  • Patients whose primary disorder is chronic atrial tachyarrhythmia with no concomitant VT or VF

Technical Considerations

Implantation of an implantable cardioverter-defibrillator (ICD) within 40 days of an acute myocardial infarction (MI)

The results from the Defibrillators in Acute Myocardial Infarction Trial (DINAMIT) and the subsequent Immediate Risk-Stratification Improves Survival (IRIS) trial which enrolled patients with left ventricular (LV) ejection fractions (EFs) of up to 35% and 40%, respectively after an MI without revascularization have shed light on this entity.[14, 15]  Although there was a significant reduction in arrhythmic death, there was an increase in nonarrhythmic death, which resulted in no overall benefit. The high-risk profile of the patients or device-related risks such as inappropriate pacing may have influenced the outcomes.[16, 17]  Due to the high risk of sudden cardiac death (SCD) in the first 30 days of acute MI, a wearable external defibrillator with reevaluation of cardiac function after 40 days is a reasonable option.[18, 19, 20]

Implantation within 3 months of coronary artery bypass graft (CABG) surgery or percutaneous coronary intervention (PCI)

The MADIT II (Multicenter Automatic Defibrillator Implantation Trial with Cardiac Resynchronization Therapy) trial and SCD-HeFT (Sudden Cardiac Death in Heart Failure Trial) enrolled patients with prior CABG or PCI. The enrollment criteria relative to time from CABG or PCI was different between the studies (MADIT II required 3 months, and SCD-HeFT required 1 month from procedure to enrollment). In a MADIT II post hoc analysis, there was a reduced benefit of ICD therapy in patients who received an ICD between 3 months and 6 months after CABG or PCI as compared to patients who received an ICD 6 months or longer after CABG or PCI.[21] However, for patients in SCD-HeFT group, ICD therapy benefit was similar regardless of the time from CABG or PCI to ICD implantation.[22]   

New York Heart Association (NYHA) class IV heart failure

The potential benefit of primary prevention in NYHA class IV patients is not defined. However, in the Cardiac-Resynchronization Therapy With or Without an Implantable Defibrillator in Advanced Chronic Heart Failure (COMPANION) trial, investigators randomized NYHA class III and IV heart failure patients with an LVEF up to 35%, and a QRS duration of 120 ms or longer to optimal medical therapy, CRT, or CRT with an ICD (CRT-D).[23]  The data indicated that CRT and CRT-D significantly reduced death or hospitalization for any cause, but only CRT-D reduced all-cause mortality.

Outcomes

Primary prevention implantable cardioverter-defibrillator (ICD) therapy

In the Multicenter Automatic Defibrillator Implantation Trial II (MADIT II) study, ICD reduced all cause mortality by 31% in 1232 patients with myocardial infarction (MI) at least 30 days or longer before enrollment and an a left ventricular (LV) ejection fraction (EF) of 30%.[2]  Later, a post-hoc subset analysis demonstrated a survival benefit for ICD in patients with a QRS duration of at least 120 ms.[24]

A 2018 substudy report of the MADIT-Cardiac Resynchronization Therapy (MADIT-CRT) trial indicated that in CRT-treated heart failure patients, left atrial abnormality on electrocardiography (ECG) appeared to be an ECG indicator of poor long-term outcome in those with left bundle branch block (LBBB).[25]  The investigators suggested that the P-wave terminal force in lead V1 (PTF-V1) (in which a PTF-V1 of 0.04 mm/s or longer was considered abnormal) provided additional prognostic information in the context of CRT, thereby potentiating the role of ECG in stratifying risk in heart failure patients.[25]

The Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT) found ICD benefit to be similar across multiple QRS width cut-off points.[3, 26]  The study included patients with ischemic or nonischemic New York Heart Association (NYHA) class II or III heart failure and an LVEF up to 35%, and patients were randomized to ICD therapy, or amiodarone, or placebo. ICD therapy significantly reduced all-cause mortality, whereas amiodarone did not compared to placebo. The benefit was found to be similar between nonischemic and ischemic cardiomyopathy. However, although mortality reduction was associated with with NYHA class II, no benefit of ICD therapy was observed in the remaining NYHA class III patients.

A post-hoc analysis of SCD-HeFT assessed the ICD benefit across five risk groups.[27] In the NYHA class III group, some were at high risk and might have influenced the observed lack of ICD benefit. Note that mortality benefit from ICD therapy is highest in the lower and intermediate group rather than the highest risk group. In 2006, the American College of Cardiology, American Heart Association, and European Society of Cardiology (ACC/AHA/ESC) guidelines for management of patients with ventricular arrhythmias and prevention of sudden cardiac death (SCD) assigned a class I recommendation for primary prevention ICD therapy to NYHA class II and III patients with an LVEF up to 30%-40% with coronary artery disease (CAD) and prior MI. These guidelines also assigned a class I recommendation for patients with nonischemic cardiomyopathy, NYHA class II and III, and an LVEF up to 30%-35%).[28]

In the 2008 ACC/AHA/Heart Rhythm Society (HRS) guidelines, the ranges of LVEF were streamlined to LVEF up to 35% except for NYHA class I coronary artery disease patients with an LVEF up to 30% who are not cardiac resynchronization therapy (CRT) candidates but who are awaiting cardiac transplantation can be considered for a primary prevention ICD implantation (class IIa).[8]

Preliminary data indicate that not only do elderly patients (≥75 years) undergo CRT with ICD less often than younger patients,[29] but the elderly do not appear to derive a survival benefit with the addition of an ICD.[30]

In a study that evaluated the role of ICD implantation for primary prevention of SCD in 212 high-risk patients with long QT syndrome (LQTS), investigators identified clinical and genetic variables associated with appropriate shock risk, which have the potential for use in risk stratification in this patient population.[31]  For example, factors associated with an increased risk of appropriate shock included a corrected QT interval (QTc) of 550 ms or longer and previous syncope while on beta-blockers. LQT2 and multiple mutations were associated with a greater risk for recurrent shocks relative to LQT1.[31]

Wearable cardioverter-defibrillators appear to be a safe and effective alternative for pediatric patients with ventricular arrhythmias at  high risk for SCD but who are not ideal candidates for placement of ICDs.[32]

Secondary prevention ICD therapy

The results of the National Institutes of Health-funded Amiodarone Versus Implantable Defibrillator study (AVID)[1]  (which enrolled survivors of cardiac arrest, patients with syncopal ventricular tachycardia [VT], and patients with symptomatic VT with an LVEF up to 40%) showed a significant reduction in all-cause mortality for patients treated with an ICD compared to those who received antiarrhythmic medication.[1]

The Canadian Implantable Defibrillator Study (CIDS) and the Cardiac Arrest Study Hamburg (CASH) trial both demonstrated a trend toward mortality reduction with ICD therapy.[33, 34]  Therefore, secondary prevention ICD therapy is a class I recommendation for patients meeting AVID criteria in ACC/AHA guidelines.[8, 28, 35]  In a meta-analysis of AVID, CASH, and CIDS, the ICD therapy benefit was found to be limited to patients with LVEF of 35% or below.[36]

 

Periprocedural Care

Periprocedural Planning

Implantable cardioverter-defibrillators (ICDs) are devices that can record the heart’s activity and treat dangerous arrhythmias with a shock. Many defibrillators work as a pacemaker as well, if the heart rate is too slow. They can deliver pacing should a ventricular arrhythmia occur to terminate it without delivering a shock. Some ICDs may also deliver cardiac resynchronization therapy (CRT) to improve cardiac function if they have multiple pacing leads.

The heart’s activity is recorded by the ICD and can be retrieved during an office visit, or during a remote home monitoring transmission. This allows the healthcare provider to review the patient's heart’s activity and to help properly treat rhythm disorders.

Generally, ICDs are recommended for patients who have survived cardiac arrest or who have experienced episodes of spontaneous, sustained ventricular tachycardia (VT) or ventricular fibrillation (VF) (if not due to a reversible or transient cause). Also, ICDs are recommended for certain patients who are at high risk for VT or VF, such as those with congestive heart failure who have not had prior episodes of these arrhythmias.

Laboratory studies

Generally, platelet counts (preferred platelet counts: >50 × 103 per μL) and the international normalized ratio (INR) are checked to assess the risk of bleeding. However, uninterrupted warfarin use has been found to be safe, and it has become routine practice.[37]

Some clinicians will check a hemoglobin A1c level prior to implantation to ensure diabetic patients' condition is well controlled to reduce the risk of infection.

Anesthesia

Implantation of an ICD usually involves a combination of local anesthesia and conscious sedation. Conscious sedation may be administered in the form of intravenous (IV) midazolam and fentanyl. On infrequent occasions, general anesthesia may be obligatory in an extremely uncooperative or high-risk patient. Typically, the procedure takes 30 to 90 minutes to complete.

Implantation

The procedure involves an incision below the collarbone. The leads will be threaded through a vein into the heart. One lead will be placed in the right ventricle and one in the right atrium. For CRT, a third lead will be placed in the coronary sinus.

After the procedure

A chest x-ray is performed to confirm the leads are in the proper position and the lung has not been injured. Following the procedure, patients usually stay overnight in the hospital.

Subcutaneous ICD

A subcutaneous ICD (S-ICD) may be placed under the skin with no leads inside the heart. It is placed along the rib cage below the armpit or left axilla. The lead is tunneled underneath the skin. The advantages of this technique include a lower risk of infection because the lead is not directly in the blood stream. However, the device itself is larger compared to the transvenous device, and it is not able to provide pacing for slow heart rates, CRT, or antitachycardia pacing.

Equipment

Equipment used in the placement of an implantable cardioverter-defibrillator (ICD) includes the following:

  • Surgical tray
  • Fluoroscope
  • Surgical tray
  • Peelable hemostatic sheath(s)
  • External defibrillator
  • ICD pulse generator and lead(s)
  • Pacing cable(s)
  • Pacing system analyzer (PSA)

ICD systems consist of a pulse generator and pacing leads. Endocardial leads are inserted transvenously and advanced to the right ventricle, where they are implanted into the myocardial tissue. The pulse generator is placed subcutaneously or submuscularly in the chest wall.

On September 28, 2012, the US Food and Drug Administration approved the first subcutaneous ICD for ventricular tachyarrhythmias, which allowed the lead to be placed under the skin rather than through a vein into the heart.[38]

Patient Preparation

Anesthesia

For the overwhelming majority of patients, local anesthesia with lidocaine and conscious sedation are sufficient. Local anesthetic should be infiltrated into the skin and subcutaneous tissue. The entire area can be effectively anesthetized with one or two injections with repositioning of the needle. Repeated skin penetration by the anesthetic needle should be avoided, because it increases the risk that bacteria will be introduced.

In select patient populations, consideration should be given to general anesthesia; such populations include pediatric patients, as well as patients in whom placement of a subpectoral implantable cardioverter-defibrillator (ICD) will be performed and those who will require lead tunneling.

Positioning

The patient’s hair should be secured with a surgical hat because of its proximity to the incision. The chest should be shaved with a clipper rather than with a razor to avoid skin injury, which creates a portal for bacteria entry.

The patient should be positioned supine. In rare cases, left arm extension may be necessary to allow submammary device placement. External defibrillator patches should be placed anteriorly and posteriorly.

The author prefers that the ICD insertion area be first cleaned with detergent solution and then dried and subsequently prepared with chlorhexidine-based products; this may promote more rapid healing after ICD insertion and may diminish bacterial growth. Patients should also undergo a whole-body wash (including a hair wash) with a disinfecting solution 24 hours before implantation.

 

Technique

Approach Considerations

Placement of an implantable cardioverter-defibrillator (ICD) is considered a minimally invasive procedure. Transvenous access to the ventricle and atrium are performed typically under local anesthesia. Most commonly, access is through the subclavian vein, cephalic vein, femoral vein, or, rarely, internal jugular vein. The procedure may occur in the cardiac catheterization laboratory or in the operating room.

Incision

The skin incision is usually made in the right or left infraclavicular area, depending on the patient’s handedness. Generally, it is preferred that the implantable cardioverter-defibrillator (ICD) be inserted on the side opposite the patient’s dominant hand. Other considerations for choosing the implant site include the following:

  • Previous mastectomy or lymph node resection: Such sites should be avoided.

  • Recreational activities: In hunters, for example, the site on which the gun butt rests should be avoided for implantation.

  • Existing cardiac devices: When an upgrade to a defibrillator is planned, the site where the previous device was implanted is preferred, provided that the venous circulation is sufficiently patent to allow lead placement.

The positioning of the incision depends to a large extent on the planned vascular access. If a cephalic vein cutdown is planned, an incision in the deltopectoral groove may be preferred for easy visualization of the vein and creation of a subpectoral pocket with minimal bleeding. If axillary vein access is planned, the incision should be guided fluoroscopically by inspection of the position of the first and second ribs.

In patients who have a preexisting cardiac device in place, it is important to ensure that the incision both provides easy access to vascular structures and is not too far from the existing system.

Creation of Pocket

Subcutaneous

For a subcutaneous pocket, an incision 5-7 cm in length is made and carried down to the subcutaneous tissue. Hemostasis is achieved by means of electrocauterization, with care taken to avoid any skin burns that may impede the healing process. Dissection is extended to the prepectoral fascia with electrocauterization, blunt dissection, or both. It should not continue beyond the prepectoral fascia; doing so usually results in bleeding from the pectoralis muscle.

Once the incision is carried down to the prepectoral fascia, electrocautery is used to create a new plane in the inferior part of the incision with the help of an Army-Navy retractor. The pocket that will accommodate the device is then created with a combination of electrodissection and blunt dissection with the fingers. The pocket should be directed obliquely medially to prevent device migration on the lateral aspect of the chest. The size of the pocket depends primarily on the size of the device that will be used.

Once the pocket has been created and hemostasis achieved, attention is turned toward obtaining vascular access.

Subpectoral

For a subpectoral pocket, the author prefers, if possible, to use cephalic vein access for placement of leads; the incision is made in the deltopectoral groove, and the cephalic vein is easily visualized. The incision is carried down to the prepectoral fascia and down to the deltopectoral groove, usually first with the cautery and subsequently with blunt dissection to avoid injury to the cephalic vein. The cephalic vein is then isolated and secured.

Subsequently, the lateral edge of the deltopectoral muscle is lifted and gently separated from the pectoralis minor by using blunt dissection with Metzenbaum scissors. Blunt dissection with fingers may also be used at this point. Careful attention must be paid to hemostasis at this stage of the procedure.

Once the subpectoral pocket has been created, attention is turned toward obtaining vascular access.

Placement of Pacing and Defibrillation Lead(s)

Choice of ventricular lead(s)

Several models of defibrillation leads are  available. The author prefers to use active fixation leads, which allow controlled placement in the intraventricular septum. Passive fixation leads, however, require a more apical position, thereby increasing the risk for ventricular perforation and the complications associated with it. Several other aspects of the lead design must also be considered, including the sensing circuit and the presence or absence of a proximal defibrillation coil.

The pace-sensed part of the lead either allows sensing from the tip of the lead to the dedicated ring in the immediate vicinity of the distal defibrillation coil or provides a larger sensing vector between the tip of the lead and the distal (right ventricular) defibrillation coil.

The defibrillation leads may have two defibrillation coils, with the distal coil placed in the right ventricular apex and the more proximal coil typically extending from the junction of the high right atrium to the superior vena cava (SVC), or it may have only a single distal defibrillation coil.

The single-coil defibrillation system has multiple advantages, including easier extractability in the future, in that there is much less adhesion and scarring in the area of contact between the proximal coil and right atrium/SVC junction. Single-coil defibrillation leads also take up less space in the SVC (and hence have less risk for vein occlusion) and are easier to place in patients who already have multiple existing pacing leads.

For these reasons, the author prefers to use single-coil leads. This system has tremendous benefits, especially in younger patients, in that it permits the physician to anticipate future needs for the placement of new leads, as well as for extraction. Use of single-coil leads is probably less of an advantage in patients who are older and have a shorter life expectancy, given the expected longevity of the defibrillation system.

Finally, one of the defibrillation lead models comes with a polytetrafluoroethylene (PTFE) coating on the defibrillation coils that may decrease tissue ingrowth[39] and diminish collision artifact in comparison with existing pacing and defibrillation leads.[40]

Placement of the lead(s)

The steerability of the lead depends on the shape and thickness of the stylet. At the same time, keep in mind that insertion of even the softest stylet in the lead dramatically increases the force transmitted via the lead; thus, considerable care must be exercised at all times during lead manipulation to avoid heart perforation.

To cross the tricuspid valve, the stylet must be curved to facilitate passage. Such curving usually does not create any difficulty with traversing the venous system and the right atrium. Should any difficulty arise, a straight stylet may be inserted and the lead advanced to the right atrium. If the venous system exhibits significant tortuosity or if multiple leads are already present, a hydrophilic wire should be inserted first, followed by a long peel-away sheath, to enable easy maneuvering of the lead.

The lead is then advanced to the right ventricle and subsequently to the right ventricular outflow tract (RVOT) to confirm that it is indeed placed in the right ventricle. In this instance, the lead will be located most anteriorly over the heart silhouette in the right anterior oblique (RAO) projection. This ensures that the lead has not inadvertently crossed a patent foramen ovale (PFO) or, potentially, a ventricular septal defect (VSD) and, ultimately, into the left ventricle.

The observation of premature ventricular contractions (PVCs) as the lead is advanced to the ventricle does not confirm right ventricular placement, because placement of the lead in the left ventricle will also result in PVCs.

At this time, the stylet is removed, and another stylet (a soft one with 135° angulation at the distal 2-3 cm) is placed in the lead. Counterclockwise torque is maintained on the stylet as the lead is slowly withdrawn from RVOT allowing it to drop to the lower portion of the right ventricle. The lead is then gently advanced, with counterclockwise rotation maintained, to allow septal positioning of the lead.

Once the entire length of the distal defibrillation coil has traversed the tricuspid valve, the lead position is inspected in the left anterior oblique (LAO) projection. In this projection, the tip of the lead should be pointing to the right of the screen, apposed to the intraventricular septum in a perpendicular fashion.

If the positioning is unsatisfactory, the lead is withdrawn slightly, the stylet is rotated clockwise or counterclockwise, and the lead is advanced once more. If these steps are not helpful, the lead may not have crossed the central portion of the tricuspid valve and may be caught in the chordal apparatus. In this setting, the lead should be withdrawn to the right atrium and the entire process repeated.

Once the fluoroscopic position of the lead is satisfactory, the Alligator type testing wires should be used to assess the appropriate sensing, pacing, impedance parameters (the cathode connects to the distal pacing pole; the anode, to the proximal pacing pole [ring electrode]) using a pacing system analyzer (PSA). Initial sensing (R wave amplitude) should be checked via the PSA; it should be at least 5 mV or greater. The lead can be repositioned to achieve better sensing if less than 5 mV is noted.

In patients with existing leads, pay careful attention to the new lead placement to ensure that any new lead is remote from the previously placed leads, because a possibility always exists that collision artifact may be generated by the new lead touching the old lead ("chattering"). If chattering occurs, it can be sensed/detected as a ventricular arrhythmia by the device, resulting in inappropriate shocks. Any lead position on the intraventricular septum from the RVOT to the apical septum may be acceptable; no specific sites have been documented to be particularly advantageous.

Once appropriate sensing has been confirmed, the lead is fixed by extending the fixing screw. After lead fixation, the stylet is pulled to one third of its length, and the position of the lead is again inspected in the anteroposterior (AP) view to reconfirm that the entire defibrillation coil has passed the tricuspid valve and that there is enough slack left on the lead. At this time, the electrical waveform should be evaluated carefully on an analyzer.

Evaluation of electrical parameters

It is important to look for the "current of injury" on the PSA, which is shown as ST elevation; higher ST elevation has been associated with lower dislodgment rates. The lead impedance is checked to verify that it is in the appropriate range (as indicated by the lead manufacturer), bearing in mind that too aggressive fixation can cause perforation. Typically, an acceptable impedance range is 300-1100 ohms, depending on the lead manufacturer. A capture threshold of less than 1 V is acceptable. The author always uses high-output pacing (10 V and 1 msec) to ensure that no phrenic nerve stimulation (which causes diaphragmatic contraction) is noted.

Securing of the lead(s)

If the electrical parameters are acceptable, the hemostatic sheath is spilt and pulled, and a suture sleeve is advanced over the lead to the level of the muscle to provide hemostasis at the access site, securing it to the pocket's floor using nonabsorbable sutures. If there is significant bleeding from the access site as a result of increased central venous pressure, a purse-string suture may be placed around the access site; this usually yields appropriate hemostasis.

Appropriate slack should be provided to allow the lead to move freely without placing any traction on the myocardium. Especially in obese patients, the slack is usually substantial because, in the recumbent position, the diaphragm and the heart are significantly displaced superiorly. In pediatric patients, pay careful attention to the amount of slack that remains in the right atrium. If significant additional growth is expected, a large loop may be left in the right atrium to allow the lead to follow the growth of the heart.

The lead is usually secured to the pectoralis muscle with 0 to 2-0 silk sutures, with the initial ties placed on the muscle right below the lead. Several knots should be made for secure placement, but avoid a very tight ligature on the pectoralis muscle to minimize the risk of muscle necrosis. If muscle necrosis does occur, the necrotic part of the pectoralis muscle can detach itself from the rest of the muscle, resulting in dislodgment of the lead. Once secured, the lead should be inspected for appropriate slack and adjusted accordingly.

Subsequently, the suture is wrapped around the suture sleeve, and several more knots are securely tied, with constant tension maintained on the silk suture to keep the lead from moving. A minimum of two sutures should be applied over the suture sleeve for secure lead placement. Always check to ensure the lead cannot be moved in the suture sleeve. Once this is achieved, the stylet is fully withdrawn from the lead.

Connection to the device

The lead connectors are cleaned with wet and dry gauze to ensure that there is no contamination by blood. If the lead has separate connections for the pacing-sensing portion and for the defibrillation coils (ie, does not have an IS-4 connector), it is critical to confirm that these connections are not switched. Such an error may result in inappropriate therapy from the device in the future. This is particularly critical for defibrillation systems using extended bipolar sensing leads (eg, those from Boston Scientific).

In patients undergoing implantation with a single-coil lead (which has only a distal coil), the channel for the proximal coil must be plugged with the DF-1 connector plug and secured in the device. With the new IS-4 connector, such considerations have become obsolete, because there is only one connection for the entire ICD lead.

Some manufactures require that the connector channels be “burped” by inserting the torque wrench in the receptacle before inserting the lead. This should always be done with the IS-1 connectors (for high-voltage defibrillation lead terminals). If there is more than one screw securing the lead in the header, the distal screw must always be tightened first and the lead pulled to ensure good mechanical connection.

Insertion of Generator

Following placement of the pacing and defibrillator lead(s), an anchor suture is placed in the superior and medial aspect of the pocket. The pocket is irrigated with an antibiotic solution. Any of several antibiotics can be used; the choice is generally dictated by the facility’s infection control policy. The author typically uses either cephalexin or, in patients with penicillin and cephalosporin allergy, bacitracin or vancomycin. Although there is no direct evidence that this technique is helpful, the orthopedic experience suggests that the mechanical force of the washing may remove at least some contaminants.

Once pocket lavage is completed, the device is placed in the pocket. It is important to place the lead(s) in the bottom of the pocket and then to position the device in such a way that it covers the lead(s). As noted earlier, this protects the lead(s) during any future pulse generator (PG) change. With this positioning, the first element of the device that will be encountered in the dissection is the implantable cardioverter-defibrillator (ICD) PG itself or its header, either of which is far more resistant to mechanical or electrical injury than a lead is.

For devices that are placed subpectorally, interrupted sutures with absorbable material are used to suture the pectoralis major to the deltopectoral muscle. For devices that are placed subcutaneously, an initial layer of 0 to 2-0 absorbable suture (placed in a continuous fashion) is necessary to ensure pocket integrity. When suturing, the author prefers to direct the needle in an inferior-to-superior direction to avoid inadvertently damaging the lead(s) or the device.

Subsequent suture layers are dictated by the body habitus. In patients with a very thin layer of adipose tissue, usually only an intradermal layer is required. In obese patients, another continuous layer of absorbable 2-0 suture material may be necessary. Horizontal suturing should be used. For the intradermal layer, absorbable 4-0 monofilament material is necessary for good apposition of the incision edges.

Once the incision is entirely closed, either cyanoacrylate glue or adhesive strips (skin closure strips) may be used to cover the incision. If cyanoacrylate glue is used, no further dressing is necessary. If skin closure strips such as Steri-Strips are used, an occlusive sterile dressing should be applied on top of the incision. Relatively recently, a sterile Aquacel dressing has been used to replace the Steri-Strips on surgical sites.

Testing of the Defibrillation Threshold

After the lead is secured and connected to the defibrillator, and the defibrillator is placed in the pocket, but before the pocket is closed, defibrillation threshold (DFT) testing should be performed in some patients. Although there is some controversy in the literature over the utility of DFT testing, with some studies showing it to have little clinical relevance,[41] some practitioners still use it in this setting.[42] The most common reasons for not performing DFT testing include very advanced heart failure, recent heart failure exacerbation, borderline hemodynamic status, and the presence or suspicion of intracardiac thrombi, as well as in patients with atrial fibrillation in whom anticoagulation had been stopped before surgery.

After DFT testing is completed, the pocket can be closed.

Steps in testing

Deep sedation is necessary for this part of the procedure to minimize patient discomfort. This is achieved with a combination of midazolam and fentanyl, with propofol, or with etomidate, as appropriate for the patient.

Several techniques may be used for the induction of ventricular fibrillation (VF). The most commonly used techniques include the following:

  • Low-energy shock of 1-1.2 J on the T-wave

  • Brief application of direct current to the myocardium

  • Burst pacing (50- to 60-Hz)

There should be two defibrillators (preferably biphasic waveform) in the room, one connected to the patient and one used as a backup. The defibrillator should be charged before VF induction (200 J is usually satisfactory). When VF induction is achieved, the device detects the arrhythmia, charges energy, and defibrillates the heart (with either the first or the second shock). If defibrillation fails, the patient should be immediately defibrillated with an external defibrillator.

Multiple algorithms for DFT testing have been published. Most of these have some utility for research purposes, but, in practice, it may make sense to follow a published protocol that simplifies the process.[43] The first energy shock is programmed to 14 J, and the distal coil is programmed to be a cathode; the second shock is programmed to be 10 J less than the maximal energy of the device. The 10 J safety margin has been traditionally considered satisfactory, although no randomized clinical data exist to support this view.

If the first shock fails, the device is allowed to redetect the arrhythmia, recharge, and deliver the second shock. If the second shock fails, external defibrillation rescue is necessary. If the initial 14-J shock is found to be effective in terminating the arrhythmia, further DFT is unnecessary, because it is very likely that another 14-J shock would succeed. If the defibrillation threshold is found to be higher than 14 J, another test should be performed at least 5 minutes after the initial test to allow for full hemodynamic recovery.

Management of a high defibrillation threshold

If a high defibrillation threshold (< 10 J safety margin) is encountered, there are several maneuvers that can be used to manage it.[44]

The first step is to ensure that no pneumothorax is apparent and to confirm the electrical integrity of the defibrillation system. The next (and easiest) step is to reverse the polarity of the defibrillation vector, particularly if the distal coil has not been programmed to be a cathode. If this does not improve the defibrillation threshold, the next step is mechanical or electronic elimination of the proximal coil (if present) from the defibrillation vector. The next step is to reposition the lead so that possibly more myocardial mass can be covered by the defibrillation vector.

With one of manufacturing companies (formerly St Jude Medical; bought by Abbott), additional steps can be taken even before polarity switching or elimination of the proximal coil from the defibrillation circuit and lead repositioning. Data suggest that adjusting the duration of defibrillation pulse phases and its tilt slope in accordance with the high-voltage lead impedance will improve the DFT.

If all of these maneuvers fail, additional hardware may have to be implanted to improve the DFT. Multiple techniques for additional defibrillation coil placement in the innominate vein, as well as in the coronary sinus, have been described; however, a far easier approach is to place an additional defibrillation coil subcutaneously.

Subcutaneous coil placement

Whenever possible, the author prefers to use a separate incision in the anterior or midaxillary line in the middle of the chest ipsilateral to the device. If this is not possible, the subcutaneous coil may be advanced from the device pocket. Several models are commercially available; in the author’s experience, the Medtronic model 6996SQ works well and is very easy to insert.

Initially, the sheath and the stylet that is driving the sheath should be curved, and they should be advanced under fluoroscopic guidance over the lateral aspect of the chest posteriorly to the border of the spine. Subsequently, the stylet is removed from the sheath, and another defibrillation coil is passed through the sheath to the subcutaneous tissue in the posterior aspect of the chest.

The sheath is then split, and the coil is secured in much the same way as the lead was secured to the pectoralis fascia. This coil must always be plugged in where the proximal coil plugs into the implantable cardioverter-defibrillator (ICD) pulse generator (PG).

At this time, DFT testing may be repeated. Different configurations may be tried; defibrillation may be accomplished from the subcutaneous coil to the distal coil and ICD PG, or the PG can be electrically eliminated from the defibrillation vector and defibrillation accomplished using a vector between the subcutaneous and distal coils.

Postoperative Care

Appropriate pain medication is necessary after the implantation procedure. Patients in whom the device was placed subpectorally experience significantly more pain than those in whom the device was placed subcutaneously.

Usually, an overnight stay is necessary. The next morning, if the device parameters are within the acceptable range, the pain is controlled, and no local complications are present in the pocket area, the patient can be safely discharged home. Instructions for appropriate incision care should be provided. If cyanoacrylate glue was used, patients can shower within 24 hours if they refrain from rubbing over the incision site. If skin closure strips such as Steri-Strips were used, patients should avoid showering until postoperative day 5-7, at which time the occlusive dressing is removed. If a sterile Aquacel dressing is used, the patient can shower on the day of discharge.

The evidence for postprocedural antibiotic administration is inconclusive and, for the most part, not based on randomized trials. Nevertheless, most practitioners prescribe oral antibiotics for a short period. The author typically uses cephalexin (500 mg every 8 hours for 5 days) for patients who do not have a penicillin or cephalosporin allergy, and clindamycin (300 mg every 8 hours for 5 days) for patients who are allergic to penicillin.

Patients should also be advised to avoid extreme motions of the arm on the side of the implant for up to 6 weeks. The patient should be seen within a few days after the implantation for a wound check to verify that the wound is healing appropriately.

Anticoagulant therapy is provided as warranted after the procedure. In the BRUISE CONTROL (Bridge or Continue Coumadin for Device Surgery Randomized Controlled) trial, patients at high risk for thromboembolism who remained on uninterrupted warfarin therapy before, during, and after the implantation of a pacemaker or ICD had a significantly lower device-pocket hematoma rate than did similar pacemaker and ICD patients whose antithrombotic treatment was bridged with heparin.[37, 45]

Early in-person follow-up visit improves survival after ICD implantation

An analysis of data from the ICD Registry of the National Cardiovascular Data Registry (NCDR) determined that patients who completed a follow-up clinic visit 2 weeks to 3 months after receiving an ICD, with or without biventricular pacing, had significantly greater survival over the following year than those who did not complete an in-person visit.[46, 47] Although these patients were more likely to be readmitted for cardiovascular causes, these hospital readmissions were largely for arrhythmias rather than heart failure.

Complications

Complications of placing an implantable cardioverter-defibrillator (ICD) placement include the following:

  • Inadvertent access to the axillary/subclavian artery rather than the axillary/subclavian vein
  • Arteriovenous (AV) fistula formation if both vessels (artery and vein) are accessed
  • Thrombosis of the axillary vein or subclavian vein (incidence, 1%-3%) [48]
  • Injury to the lung parenchyma, or pneumothorax or hemothorax
  • Perforation of any vascular structures, including perforation of the right atrium/ventricle and cardiac tamponade
  • Infection of the system, including intravascular hardware and endocarditis (incidence, 1%-7%) [29]
  • Local pocket hematoma
  • Obstruction of the superior vena cava by lead bulk
  • High defibrillation thresholds (DFTs) and failure to defibrillate
  • Death (incidence, 0.2%)
  • Rejection phenomena
  • Erosion through the skin/muscle
  • Oversensing, causing inappropriate shocks or undersensing/failure to detect and/or terminate arrhythmia episodes
  • Surgical complications, such as hematoma, infection, inflammation, and thrombosis; an additional complication for ICDs is the acceleration of ventricular tachycardia (VT) to a faster VT either by antitachycardia pacing (ATP) therapy or shock.

Monitoring and Follow-up

Generally, every 3 months, interrogation of the implantable cardioverter-defibrillator (ICD)/leads system is required. A programmer is placed over the ICD pulse generator (PG). Manufacturers have also developed a remote monitoring system that allows patients to have their device interrogated from home using the internet or a telephone. Remote monitoring occurs every 3 months, and patients should have their devices physically monitored once a year. The information on the device can be reviewed to examine the remaining battery life, the stability of the lead(s), the program settings, and the shock and pacing parameters, as well as assessed for rhythm disturbances.

 

Medication

Medication Summary

The goals of pharmacotherapy are to reduce morbidity and to prevent complications.

Local Anesthetics, Amides

Class Summary

Local anesthetics block the initiation and conduction of nerve impulses.Anesthetics used for the permanent pacemaker insertion include bupivacaine and lidocaine.

Bupivacaine (Marcaine)

Decreases permeability to sodium ions in neuronal membranes. This results in the inhibition of depolarization, blocking the transmission of nerve impulses.

Lidocaine (Xylocaine)

Lidocaine is an amide local anesthetic used in 1%-2% concentration. The 1% preparation contains 10 mg of lidocaine for each 1 mL of solution; the 2% preparation contains 20 mg of lidocaine for each 1 mL of solution. Lidocaine inhibits depolarization of type C sensory neurons by blocking sodium channels.

To improve local anesthetic injection, cool the skin with ethyl chloride before injection. Use smaller-gauge needles (eg, 27 gauge or 30 gauge). Make sure the solution is at body temperature. Infiltrate very slowly to minimize the pain. The time from administration to onset of action is 2-5 minutes, and the effect lasts for 1.5-2 hours.

Antibiotics, Other

Class Summary

Insertion of Generator

Prophylactic antibiotics are used for insertion of generator and postoperatively. Any of several antibiotics can be used; the choice is generally dictated by the facility’s infection control policy. The author typically uses either cephalexin or, in patients with penicillin and cephalosporin allergy, bacitracin or vancomycin, and clindamycin.

Cephalexin (Keflex)

Cephalexin is a first-generation cephalosporin that arrests bacterial growth by inhibiting bacterial cell wall synthesis. It has bactericidal activity against rapidly growing organisms. Cephalexin's primary activity is against skin flora; the drug is used for skin infections or prophylaxis in minor procedures.

Bacitracin (Baciim, Baciquent)

Bacitracin prevents transfer of mucopeptides into the growing cell wall, which causes inhibition of bacterial cell wall synthesis.

Clindamycin (Cleocin)

Clindamycin is a lincosamide that is useful in treating serious skin and soft tissue infections caused by most staphylococcal strains. It is also effective against aerobic and anaerobic streptococci, except enterococci.

Clindamycin inhibits bacterial protein synthesis by inhibiting peptide chain initiation at the bacterial ribosome, where it preferentially binds to the 50S ribosomal subunit, inhibiting bacterial growth.

Vancomycin (Vancocin)

Vancomycin is an antibiotic directed against gram-positive organisms and active against Enterococcus species. It is useful in the treatment of septicemia and skin-structure infections. Vancomycin is indicated for patients who cannot take or whose conditions fail to respond to penicillins and cephalosporins or those with infections with resistant staphylococci.