Two-incision technique for implantation of the subcutaneous implantable cardioverter-defibrillator

doi:10.1016/j.hrthm.2013.05.016

Heart Rhythm

Volume 10, Issue 8, August 2013, Pages 1240-1243

https://doi.org/10.1016/j.hrthm.2013.05.016 Get rights and content

Background

Three incisions in the chest are necessary for implantation of the entirely subcutaneous implantable cardioverter-defibrillator (S-ICD). The superior parasternal incision is a possible risk for infection and a potential source of discomfort. A less invasive alternative technique of implanting the S-ICD electrode—the two-incision technique—avoids the superior parasternal incision.

Objective

The purpose of this prospective cohort study was to evaluate the safety and efficacy of the two-incision technique for implantation of the S-ICD.

Methods

Consecutive patients who received an S-ICD between October 2010 and December 2011 were implanted using the two-incision technique, which positions the parasternal part of the S-ICD electrode using a standard 11Fr peel-away sheath. All patients were routinely evaluated for at least 1 year for complications and device interrogation at the outpatient clinic.

Results

Thirty-nine patients (46% male, mean age 44 ± 15 years) were implanted with a S-ICD using the two-incision technique. During mean follow-up of 18 months (range 14–27 months) no dislocations were observed, and there was no need for repositioning of either the ICD or the electrode. No serious infections occurred during follow-up except for 2 superficial wound infections of the pocket incision site. Device function was normal in all patients, and no inappropriate sensing occurred related to the implantation technique.

Conclusion

The two-incision technique is a safe and efficacious alternative for S-ICD implantations and may help to reduce complications. The two-incision technique offers physicians a less invasive and simplified implantation procedure of the S-ICD.

Introduction

Prevention of sudden cardiac death with an implantable cardioverter-defibrillator (ICD) has become one of the most important treatment modalities for life-threatening cardiac arrhythmias. Several trials have demonstrated significant survival benefit in both primary and secondary prevention of sudden cardiac death.¹ However, this benefit comes at the cost of ICD-related complications, among which are inappropriate shocks and implantation-related complications, such as pneumothorax, perforation, and lead dislocation.² Also, late complications such as lead fractures and infections account for significant morbidity and even mortality in ICD patients.³

In search of a solution for some of these ICD-related complications, a new entirely subcutaneous implantable cardioverter-defibrillator (S-ICD) was introduced in 2010.⁴ The S-ICD does not require leads in or on the heart. This allows for a more robust lead design. Potentially, the implantation technique and new lead design might result in increased lead longevity and fewer implantation-related complications, but this has yet to be confirmed. To date, there are only reports on the feasibility and safety of the S-ICD.4, 5

The conventional S-ICD implantation technique consists of electrode and device implantation by making 3 incisions: 1 lateral pocket incision and 2 parasternal incisions. The electrode is then tunneled from the lateral pocket through the parasternal incisions to its final position, and sutures are applied at all incision sites. Particularly, the superior parasternal incision, located on the sternomanubrial junction, may be a risk for infection,⁵ a potential source of discomfort, and cosmetically less appealing. On the other hand, adequate electrode positioning is important for appropriate sensing. and inappropriate shocks have been reported due to lead migrations.⁵ We present here an alternative technique for implanting the electrode that avoids the superior parasternal incision and suture, and we report on the efficacy and safety of this new implantation technique.

Section snippets

Patients

Consecutive patients who received an S-ICD between October 2010 and December 2011 were included in the study. The inclusion period was chosen to study patients with at least 12 months of follow-up. All patients were aware of the innovative aspects, limitations, and potential advantages and disadvantages of the device. Our institutional review board waived the requirement for informed consent.

Two-incision S-ICD implant technique

Procedures were performed in a catheterization laboratory or operation room under standard sterile

Results

Thirty-nine patients (46% male, mean age 44 ± 15 years) were implanted with an S-ICD using the two-incision techniques during the study period. Table 1 lists the patients’ baseline characteristics. All patients were successfully implanted using the alternative two-incision implantation technique avoiding a superior parasternal incision. DFT testing was performed in all but 2 patients. In those 2 patients, DFT testing was not performed because 1 patient was pregnant and 1 patient had a left

Discussion

The superior parasternal incision for implantation of the S-ICD is a possible risk for infection, sometimes even leading to device explantation,⁵ and is a potential source of discomfort. Using only 2 incisions instead of the currently advised 3 incisions of the labeled implantation technique is less invasive and simplifies the procedure. Moreover, the superior parasternal incision is often visible wearing normal clothing and considered, especially by female patients, to be cosmetically

Conclusion

The two-incision technique is a safe and efficacious alternative for S-ICD implantations and may help to reduce complications in S-ICD patients. The two-incision technique offers physicians a less invasive and simplified implantation procedure.

Acknowledgment

We thank Rob Kreuger for creating the images used in the figure.

References (6)

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Inappropriate implantable cardioverter-defibrillator shocks: incidence, predictors, and impact on mortality
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M.R. Sohail et al.
Management and outcome of permanent pacemaker and implantable cardioverter-defibrillator infections
J Am Coll Cardiol
(2007)
A.J. Moss et al.
Prophylactic implantation of a defibrillator in patients with myocardial infarction and reduced ejection fraction
N Engl J Med
(2002)

There are more references available in the full text version of this article.

Cited by (133)

Validation of the PRAETORIAN score in a large subcutaneous implantable cardioverter-defibrillator collective: Usefulness in clinical routine
2024, Heart Rhythm
To assess the risk of unsuccessful conversion of ventricular fibrillation during defibrillation testing (DFT) with the subcutaneous implantable cardioverter-defibrillator (S-ICD), the PRAETORIAN score has been proposed.
The purpose of this study was to validate the PRAETORIAN score in a large S-ICD collective.
A retrospective single-center analysis of S-ICD patients receiving intraoperative DFT was performed. DFT was performed using a stepwise protocol with 65-J standard polarity, change of polarity, increase to 80 J, and repositioning if necessary. If all DFTs failed, we switched to a transvenous ICD.
Overall, 398 patients were analyzed (268 male [67.3%]; mean age 42.4 ± 15.9 years; mean body mass index [BMI] 25.9 ± 4.8 kg/m²). Successful DFT with the first ICD shock was observed in 264 patients (66.3%). One hundred fourteen patients were defibrillated with the second (n = 104) or third (n = 10) DFT after changing shock polarity and/or shock energy. Overall, 20 patients needed at least 3 DFT (ie, 80 J and/or re-positioning). The majority (n = 88 [65.7%]) of DFT failures occurred before 2015 with the first-generation S-ICD. PRAETORIAN score was an independent predictor of DFT failure (odds ratio [OR] 1.007; 95% confidence interval [CI] 1.003–1.011 P ≤.001), while whereas BMI alone was not (P = .31). Presence of hypertrophic cardiomyopathy (HCM) (OR 2.6; 95% CI 1.3–4.4; P = .004) was predictive for at least 1 unsuccessful DFT in our multivariate regression analysis.
PRAETORIAN score proved to be a useful and valid predictive tool for successful DFT, whereas BMI only had a limited role. Patients with HCM were at increased risk for DFT failure or needed higher DFT energy.
Subcutaneous Implantable Cardioverter Defibrillators in Pediatrics and Congenital Heart Disease
2023, Cardiac Electrophysiology Clinics
Characterization of the PRAETORIAN score in Japanese patients undergoing subcutaneous implantable cardioverter-defibrillator implantation
2022, Journal of Cardiology
The PRAETORIAN score was developed to evaluate the implant position and predict defibrillation success in patients implanted with a subcutaneous implantable cardioverter-defibrillator (S-ICD). However, usefulness of the PRAETORIAN score for Japanese patients is unknown.
We evaluated usefulness of this score, which was determined by width of sub-coil fat, sub-generator fat, and anterior positioning of the S-ICD generator by post-operative chest X-ray, in consecutive 100 Japanese S-ICD implanted patients [78 men, median age 59 (IQR 46.5–67.0) years, median body mass index (BMI) 24.2 (21.3–27.2) kg/m²].
The median PRAETORIAN score was 30 (30–45) and 93 patients were classified as a low risk of conversion failure. The remaining seven were at an intermediate risk. Almost all patients were classified as an optimal pulse-generator position in the second and third steps of the PRAETORIAN score. The only difference observed was in the width of sub-coil fat in the first step. To further evaluate its significance, patients were divided into the Thicker group (sub-coil fat >1 coil width, n = 19) and the Thinner group (sub-coil fat ≤1 coil width, n = 81). BMI and post-shock impedance were both higher in the Thicker group than in the Thinner group [27.1 (25.6–31.6) versus 23.1 (20.9–25.7) kg/m², p < 0.001, and 75 (68–88) versus 63 (55–74) Ω, p = 0.003, respectively]. During the median follow-up periods of 888 (523–1418) days, 7 patients experienced appropriate shock therapy for spontaneous ventricular tachyarrhythmias, who were all at a low risk. No conversion failure was observed. Inappropriate shock (IAS) occurred in 11 patients, and there was no difference in IAS rate between the Thicker group (n = 2) and the Thinner group (n = 9) (p = 0.747 by log-rank test).
Most Japanese patients were classified as at low risk of conversion failure. The PRAETORIAN score may be useful for the evaluation of conversion failure in Japanese S-ICD implanted patients.
The subcutaneous implantable cardioverter-defibrillator should be considered for all patients with an implantable cardioverter-defibrillator indication
2022, Heart Rhythm O2
Subcutaneous ICD implantation under ultrasound-guided serratus anterior plane block: Single-center experience in the Netherlands
2022, IJC Heart and Vasculature
To avoid general anesthesia (GA) and improve postoperative pain management for subcutaneous implantable cardioverter-defibrillator (S-ICD) implantation there is a growing interest for alternative methods. We describe the first experience in the Netherlands of S-ICD implantation under Ultrasound-guided Serratus Anterior Plane Block (US-SAPB).
US-SAPB was performed 1 hour before S-ICD implantation. The two-incision technique was used and a pocket beneath the latissimus dorsi muscle was surgically created. Lidocaine was used to provide anesthesia of the skin. Sedation during defibrillation testing (DFT) was induced by intravenous Propofol. Periprocedural pain experience was monitored using the Numerical Rating Scale for Pain (NRS-Pain). The results were compared with a control group of patients undergoing S-ICD implantation under GA.
Forty consecutive patients (29 Male/11 Female, median age 59 years (range 34–84 years), median body mass index 26 (range 17–41) underwent S-ICD implantation; Twenty patients under US-SAPB and twenty under GA. Median procedure time was 42 min. (range 28–60 min.) with no differences between both groups. In both groups implantations went successful and defibrillation was accomplished using 65 J. US-SAPB was successful in 19 of the 20 patients and GA was successful in all cases. Median NRS-Pain in the US-SAPB group was 2 (range 2–6) and in the GA group 4 (range 2–6). In the US-SAPB group 5 patients required additional opioids postoperatively compared to 10 patients in the GA group.
S-ICD implantation under US-SAPB is feasible, safe and reduces the need for postoperative opioids significantly. S-ICD implantation under US-SAPB seems a good alternative for GA.
Analgesic Efficacy of Regional Anesthesia of the Hemithorax in Patients Undergoing Subcutaneous Implantable Cardioverter-Defibrillator Placement
2021, Journal of Cardiothoracic and Vascular Anesthesia
Patients undergoing subcutaneous implantable cardioverter-defibrillator (S-ICD) placement usually experience substantial perioperative pain. The aim of the present study was to investigate the effect of transversus thoracic muscle plane block combined with serratus anterior plane block in patients undergoing S-ICD placement.
Double-blind, randomized controlled study.
First Affiliated Hospital of Nanchang University.
Patients aged 18-to-80 years who underwent new S-ICD placement.
A group of 80 patients randomly were allocated to either the regional group (R group) or local group (L group).
The primary endpoint was pain during S-ICD placement. The secondary outcome measures included pain intensity at rest and after movement one, three, six, 12, 24, and 48 hours after surgery; the dose of dexmedetomidine and remifentanil during surgery; 24-hour ketorolac administration; postoperative sufentanil dosage; the total duration of hospitalization; intraoperative sedation; and the incidence of hypoxemia. Mean Critical-Care Pain Observation Tool scores were significantly higher during pocket creation, lead tunneling A, and lead tunneling B in the L group compared with the R group. The R group required significantly less intraoperative dexmedetomidine, intraoperative remifentanil, postoperative sufentanil, and ketorolac consumption. Compared with the R group, the L group had higher Numerical Rating Scale pain scores at 24 hours after surgery both at rest and after movement. The intraoperative Ramsay score and the incidence of hypoxemia were significantly higher in the L group compared with the R group.
Ultrasound-guided transversus thoracic muscle plane block and serratus anterior plane block resulted in lower intraoperative Critical-Care Pain Observation Tool scores and the need for less adjunctive pain medication and sedation compared with local anesthesia in patients undergoing S-ICD placement.

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Hands OnTwo-incision technique for implantation of the subcutaneous implantable cardioverter-defibrillator

Background

Objective

Methods

Results

Conclusion

Introduction

Section snippets

Patients

Two-incision S-ICD implant technique

Results

Discussion

Conclusion

Acknowledgment

J Am Coll Cardiol

J Am Coll Cardiol

Prophylactic implantation of a defibrillator in patients with myocardial infarction and reduced ejection fraction

N Engl J Med

Hands On
Two-incision technique for implantation of the subcutaneous implantable cardioverter-defibrillator