Patient Selection

Which Patients Should Be Considered for an S-ICD?

 
The S-ICD has been implanted with great outcomes in over 99,000 patients.1 These patients are protected from both the risk of sudden cardiac death and the risks of complications with transvenous leads. The S-ICD system is guideline recommended for the majority of ICD indicated patients without a pacing indication.

Logo showing that S-ICD is guideline recommended by ESC, AHA, ACC and HRS.
 

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S-ICD 100K parients
 
Patient selection
The arrow indicates the patient prioritisation for the S-ICD based on guidelines and clinical literature8, in increasing order. Consider screening all ICD indicated patients without the need for pacing


S-ICD is Guideline Recommended 

Data visualization showing 75% of ICD-indicated patients have ≥1 comorbidity associated with device infection.
75% of ICD-Indicated Patients
Have ≥1 Comorbidity Associated
with Device Infection15-17
Data visualization showing 70% of DR and VR ICD patients under 75 have no pacing indication at implant.
70% of DR & VR ICD Patients
Under 75 Have No Pacing
Indication at Implant18-19
Data visualization showing 61% of patients may have venous stenosis following initial device implantation
61% of Patients May Have
Venous Stenosis Following
Initial Device Implantation20

 

 

Clinical Data Supports S-ICD for a Broad Group of Patients 

Both the PRAETORIAN and UNTOUCHED studies confirm S-ICD should be considered the first choice for all ICD-indicated patients without a pacing indication.

PRAETORIAN2

This investigator-sponsored trial demonstrated S-ICD had comparable performance to TV-ICD, despite including primarily older S-ICD devices and implant techniques. According to the PRAETORIAN study, S-ICD:

  • Had significantly fewer lead-related complications (1.4% vs. 6.6%, P=0.001)
  • Demonstrated fewer serious infections requiring extraction (8 TV-ICD vs. 4 S-ICD)
  • Showed a trend in fewer overall complications (5.9% vs. 9.8%, P=0.11); likely to be significantly lower at 8 years in PRAETORIAN XL

 

UNTOUCHED6

The UNTOUCHED study demonstrated patients with EMBLEM™ MRI S-ICD with SMART Pass had a 2.4% rate of inappropriate shocks at 1 year, which is as low or lower than TV-ICD devices.2,18,21,22

Chart showing the S-ICD cumulative event rate at five years was non-inferior to TV-ICD.
Chart showing S-ICD had lower inappropriate shocks (IAS) at one year than TV-ICD.
Charts showing S-ICD had fewer device- and lead-related complications than TV-ICD.



As S-ICD Technology Evolves, So Does the Clinical Data

Early S-ICD trials typically had younger patients with less advanced heart disease and “niche” indications, including channelopathies, hypertrophic cardiomyopathy, congenital heart disease or previous ICD indication. However, both the PRAETORIAN and UNTOUCHED studies included older and sicker patients. In fact, UNTOUCHED included the most traditional cohort of patients (primary prevention, LVEF ≤ 35%) and showed the S-ICD has lower inappropriate shock (IAS) rates than TV-ICDs. 

S-ICD Evolution Chart



Patient Comorbidities and S-ICD

It’s important to consider patient comorbidities and other risk factors for complications when determining whether a TV-ICD is required or if a patient should be offered both S-ICD and TV-ICD when taking a shared decision-making approach to the treatment decision.

 

Patient Comorbidities

S-ICD
Considered2,8

TV-ICD Required2,8

TV-ICD Considered2,8
Evaluating Need for Brady Pacing7,23-24

Brady pacing indication at implant

 

 

No current pacing indication, but has 1 or more of the following:

  • H/O CABG surgery
  • H/O atrial fibrillation
  • Age > 80
  • PR interval > 200 ms
  

 

No pacing indication at implant and age < 80

 

 
High Risk for TV Lead Failure25

Life expectancy > 8 years

 

 
High Risk for Infection15 H/O device infection

 

 
Prosthetic heart valve

 

  
On dialysis or renal insufficiency

 

  
Diabetes

 

  

Other risk factors:

  • COPD
  • Corticosteroid use
  • Oral anticoagulation
  • Class II-IV heart failure
  • Chronic skin disorder
  • Malignancy

 

  
High or Low Risk for ATP26-27

Ischemic or non-ischemic heart failure or ICD-indicated patient with NO history of recurrent sustained monomorphic VT

   

ICD-indicated patient WITH a history of recurrent sustained monomorphic VT amenable to ATP therapy

  

 
 
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why sicd

Why S-ICD?

See how S-ICD helps protect patients at risk for sudden cardiac death while also eliminating the risk of TV-ICD lead complications.

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Clinical Data

Clinical Data

Explore clinical outcomes and learn about the first prospective, randomized, non-inferiority clinical trial comparing S-ICD to TV-ICD

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Videos & Resources

Hear physician perspectives about S-ICD, find media information, and download product images, patient videos and more.

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