Pulsed radiofrequency energy device (PEAK plasmablade™) and CustomBone® Cranioplasty: an appealing surgical rendez-vous.

BACKGROUND: CustomBone® prosthesis is a widely recognized effective and successful technique for the reconstruction of cranial bone defects. Prior the cranioplasty implant, meticulous dissection within thick scar tissue is required. During this delicate surgical manoeuvre is vital to avoid damage to the skin flap itself and to the underlying cerebrovascular structures. We report our experience and potential applications of a novel, pulsed monopolar radiofrequency energy device (PEAK PlasmaBlade™, Medtronic plc). It reduced the incidence of post operativesubgaleal hematoma, the operative times and the intra operative blood loss following cranioplasty compared to the traditional scalpel and scissor dissection. METHODS: The authors present a one centre case series study to review the indications, safety and efficacy of the PEAK PlasmaBlade™ in adult patientsunderwent cranioplasty. Two surgical techniques for tissue dissection were compared: PEAK PlasmaBlade™ versus scalpel and scissor dissection (SSD). Treatment outcomes following each of these surgical approaches, relative to rate of post-operative subgalealhematoma formation, hospital admission, and operative times were compared. RESULTS: A total of 10 patients that had cranioplasty treatment were evaluated. In patients underwent scalp dissection with the PEAKPlasmaBlade™, we observed a reduction in the operative times, in the subgaleal hematoma formation and then in the hospital stay. CONCLUSION: PEAK PlasmaBlade™ revealed to be a safe and effective device in tissues dissection for cranioplasty implant. It provided reduction of the rate of subgaleal hematoma formation, operating times and less potential risk to damage cerebrovascular structures.

Lead damage after cardiac implantable device replacement procedure: Comparison between electrical plasma tool and electrocautery.

BACKGROUND: Lead damage is a complication caused by lead manipulation or heating damage from conventional electrocautery (EC) after cardiovascular implantable electronic device (CIED) replacement. Application of electrical plasma (PEAK PlasmaBlade) is a new technology that reportedly reduces this risk. OBJECTIVES: This study was designed to compare the effect of EC versus PEAK PlasmaBlade on lead parameters and complications after generator replacement procedures. METHODS: We retrospectively studied 410 consecutive patients (840 leads) who underwent CIED replacement using EC (EC group) and 410 consecutive patients (824 leads) using PEAK PlasmaBlade (PlamaBlade group). Pacing lead impedance, incidence of lead damage, and complications were compared between both groups. RESULTS: Lead impedance increased in 393 leads (46.8%) in the EC group versus 282 leads (34.2%) in the PlasmaBlade group (p < .01) with average percent changes of 6.7% and 4.0% (p < .01), respectively. Lead impedance decreased in 438 leads (52.1%) in the EC group versus 507 leads (61.5%) in the PlasmaBlade group (p < .01) with average percent changes of -5.7% and -7.1% (p < .01), respectively. Lead damage requiring lead revision occurred in five leads (0.6%) or after five procedures (1.2%) in the EC group compared to three leads (0.4%, p = .50) or after three procedures (0.7%, p = .48) in the PlasmaBlade group. There were no significant differences in the procedural-related complications between the EC group (nine patients, 2.2%) and the PlasmaBlade group (five patients, 1.2%, p = .28). CONCLUSION: Conventional electrocautery can potentially damage lead insulations. However, this study shows that when used carefully electrocautery is as safe as the PEAK PlasmaBlade™.

Effect of low-thermal dissection device versus conventional electrocautery in mastectomy for female-to-male transgender patients.

Subcutaneous mastectomy, the first step in sexual reassignment surgery of female-to-male transsexuals, is associated with high rates of complication and revision surgery. Also, conventional electrosurgery and the associated thermal tissue damage may compromise outcome. This retrospective randomised clinical study evaluated the effect of low-thermal plasma dissection device (PEAK PlasmaBlade, Medtronic, Minneapolis, Minnesota) in comparison with conventional electrosurgery. A total of 17 female-to-male transsexuals undergoing mastectomy were randomised to PEAK PlasmaBlade on one breast side and to monopolar electrosurgery on the other side of the same patient. Wounds of 17 patients were examined histologically for acute thermal injury. Significantly less total volume of drain output (58.8 ± 37.4 mL vs 98.5 ± 76.4 mL; P = .012) was found on the PEAK PlasmaBlade side compared with the electrosurgery side. Duration of drain was significantly shorter on the PEAK PlasmaBlade side (2.5 ± 0.7 days vs 3.2 ± 0.6 days; P = .010). Furthermore, the PEAK PlasmaBlade side showed fewer thermal damages (41.2% vs 82.4%; P = .039) and thermal injury depth from PEAK PlasmaBlade side was less (3170 vs 4060 µm). PEAK PlasmaBlade appears to be superior to monopolar electrosurgery for mastectomy in female-to-male transsexuals, because it demonstrated less thermal tissue damage, less total volume of drain output, and shorter duration of drain, resulting in faster wound healing.

Bilateral reduction mammaplasty with pulsed electron avalanche knife PlasmaBlade™ and conventional electrosurgical surgery: A retrospective, randomised controlled clinical trial.

Wound-healing disorders are common complications in bilateral reduction mammaplasty. Traditional electrosurgical devices generate large amounts of thermal energy, often causing extensive thermal-related collateral tissue damage. This study aimed to retrospectively analyse the operative performance of a novel low-thermal plasma dissection device (pulsed electron avalanche knife-PEAK PlasmaBlade™) compared with traditional electrosurgery. Twenty patients with breast hypertrophy were randomly treated with PEAK PlasmaBlade™ on one breast and conventional electrosurgery on the other. Primary outcome measures were resection weight, drain duration, total drainage volume, and drain output on the first postoperative day. Breasts treated with PEAK PlasmaBlade™ had significantly higher resection weights (728.0 ± 460.1 g vs 661.6 ± 463.4 g; P = .038), significantly lower drain output on the first postoperative day (15.9 ± 15.2 mL vs 27.6 ± 23.5 mL; P = .023), and significantly lower drain durations (2.8 ± 1.0 days vs 3.3 ± 1.0 days; P = .030). Mean total drainage volume was lower where breast reduction was performed with PEAK PlasmaBlade™, but this difference was not significant. No major complications occurred, but wound-healing disorders were documented in almost one-third of the patients (35.0%, n = 7). The PEAK PlasmaBlade™ seems to be superior to conventional electrosurgery for bilateral reduction mammaplasty in terms of tissue damage and wound healing.

PEAK PlasmaBlade versus monopolar electrocautery tonsillectomy in adults: A prospective double-blinded randomized controlled trial.

OBJECTIVE: To evaluate the efficacy and compare postoperative pain and recovery following PEAK PlasmaBlade and monopolar electrocautery tonsillectomy in adults. STUDY DESIGN: Prospective double-blinded randomized controlled trial. METHODS: Fifty-eight patients were recruited and randomized into 2 groups: PEAK PlasmaBlade (n = 29) or monopolar electrocautery (n = 29) tonsillectomy. Postoperative pain, complications, patient satisfaction, number of tablets of analgesia taken and days taken to return to soft diet, normal diet, normal activities and achieve pain-free swallowing were compared and analysed, with the aid of a pain diary given to patients. Statistical analysis was performed with SPSS 13.0 with statistical significance set at P < 0.05. RESULTS: Patients in the PEAK PlasmaBlade group were able to achieve pain-free swallowing in a shorter time compared to the electrocautery group (13.28 versus 15.76 days, P = 0.035). Patients were also more satisfied with PEAK PlasmaBlade tonsillectomy (P = 0.046). No significant differences in the incidence of postoperative haemorrhage, daily visual analog score for pain, number of tablets of analgesia taken and time taken to return to soft diet, normal diet and activities were seen for both groups. CONCLUSIONS: This study showed that PEAK PlasmaBlade tonsillectomy has a faster recovery period in terms of time taken to achieve pain-free swallowing and may offer advantages when compared to monopolar electrocautery tonsillectomy. LEVEL OF EVIDENCE: 1b.

Comparative analysis on the effect of low-thermal plasma dissection device (PEAK PlasmaBlade) vs conventional electrosurgery in post-bariatric abdominoplasty: A retrospective randomised clinical study.

Post-bariatric patients undergoing abdominoplasty have a relatively high risk of complications due to residual obesity and major comorbidities. Also, conventional electrosurgery and the associated thermal tissue damage may compromise outcomes. This retrospective randomised clinical study evaluated the effect of low-thermal plasma dissection device (PEAK [pulsed electron avalanche knife] PlasmaBlade) in comparison with conventional electrosurgery. A total of 52 post-bariatric patients undergoing abdominoplasty were randomised to PEAK PlasmaBlade (n = 26) and to monopolar electrosurgery (n = 26). Wounds of 20 patients per group were examined histologically for acute thermal injury depth. In PEAK PlasmaBlade incisions, acute thermal damage was significantly reduced compared with standard of care (40% vs 75%; P = .035). Also, acute thermal injury depth from PEAK PlasmaBlade was less than that from electrosurgery (2780 µm vs 4090 µm). Significantly less total complication rate (30.8% vs 69.2%; P = .012) was found by PEAK PlasmaBlade compared with electrosurgery. Moreover, the PEAK PlasmaBlade showed less than half as many wound healing problems (19.2% vs 46.2%; P = .075), far fewer secondary bleeding (7.7% vs 30.8%; P = .075), and no seroma compared with four seroma with the standard of care (0% vs 15.4%; P = .11). PEAK PlasmaBlade appears to be superior to traditional monopolar electrosurgery for post-bariatric abdominoplasty, because it demonstrated significantly less tissue damage, less total complication rate, and fewer postoperative seroma resulting in faster wound healing.

Comparative analysis on the effect of low-thermal plasma dissection device (PEAK PlasmaBlade) versus conventional electro surgery in post-bariatric body-contouring procedures: A retrospective randomised clinical study.

Postoperative wound-healing problems are relatively high in post-bariatric body-contouring procedures, partly because of electrosurgery and the associated thermal tissue damage. This study is a retrospective randomised evaluation of the effect of a low-thermal plasma dissection device (PEAK PlasmaBlade, Medtronic, Minneapolis, Minnesota) in comparison with conventional electrosurgery. A total of 24 patients undergoing upper arm or medial thigh lifting were randomised to PEAK PlasmaBlade on one side and to monopolar electrosurgery on the other side of the same patient. Wounds of 10 patients were examined histologically for acute thermal injury depth. Significantly lower total volume of drain output (61,1 ± 70,2 mL versus 95,1 ± 176,0 mL; P = .04) was found on the PEAK PlasmaBlade side compared with the electrosurgery side. Furthermore, the PEAK PlasmaBlade side showed fewer seromas (no case of seroma versus three seromas in the electrosurgery group) and less thermal damage (40% versus 70%; P = .26). Acute thermal injury depth from the PEAK PlasmaBlade was less than from monopolar electrosurgery (425 ± 171 µm versus 686 ± 1037 µm; P = .631). PEAK PlasmaBlade appears to be superior to traditional monopolar electrosurgery for post-bariatric body-contouring procedures because it demonstrated less tissue damage, lower total volume of drain output, and fewer postoperative seromas resulting in faster wound healing.

An electrical plasma dissection tool for surgical treatment of chronic ulcers: Results of a prospective randomised trial.

Cutaneous ulceration is a difficult medical problem and a major source of morbidity for patients. In the surgical treatment of ulcers, debridement is the first step, and it can be carried out using several surgical tools. Recently, new surgical devices have emerged using plasma-mediated electrical discharges with a lower peak temperature. A prospective single-blind trial was conducted on chronic ulcers not responsive to common non-surgical management. Patients were randomly separated into 2 groups: Group A received surgical debridement with conventional electrocautery, and Group B received surgical debridement using the plasma-mediated device. Histological samples were collected intraoperatively to evaluate the thermal damage during the surgical procedure and 2 weeks after surgery to evaluate the inflammatory response and collagen deposition. The width of coagulation necrosis at the incision margins in Group B was significantly shorter compared with Group A (P = .001). The inflammatory cell infiltration showed a cellular distribution percentage that was quite equal between the 2 groups. The granulation tissue showed an abundant deposition of dense and mature collagen in Group B, compared with Group A, where the mature collagen appeared in small quantities (P < .001). Microbial culture showed a lower incidence of postoperative infections in Group B compared with the control group (P < .05). The study demonstrated, based on the results, that the new technology with the use of a lower temperature electrosurgical device represents an effective therapeutic weapon for the surgical treatment of skin ulcers, both vascular and extravascular types.

An electrical plasma surgery tool for device replacement--retrospective evaluation of complications and economic evaluation of costs and resource use.

BACKGROUND: Device replacements bear many potential risks for patients. Electrocautery should be used cautiously because of heating of the cautery tip which may lead to insulation melting. The PEAK PlasmaBlade™ (Medtronic Inc., Minneapolis, MN, USA) uses a novel technology to cut tissue. The objective of this study was to evaluate if this instrument is less destructive and can decrease complications and shorten procedure times. METHODS AND RESULTS: Two groups were compared: in group 1, surgery was done with scissors and conventional electrocautery, whereas the PEAK PlasmaBlade™ was used in group 2. Procedure time and complication rates were retrospectively investigated. Group 1 comprised 509 patients, while group 2 consisted of 102 patients. Procedure time in group 2 was significantly shorter with 28.4 ± 8.9 minutes than in group 1 with 47.5 ± 24.5 minutes (P < 0.001). The hospital stay was also reduced (2.1 ± 2.2 days versus 3.1 ± 2.4 days, P < 0.001). One major complication occurred in only 2.4% (two patients) of group 2 and in 6.9% (35 patients) of group 1. There were no damaged leads in group 2 compared to 5.7% in group 1 (P = 0.008). Cost analyses showed that the use of The PEAK PlasmaBlade™ instead of conventional electrocautery resulted in cost savings of €120/patient. CONCLUSION: Device replacement is associated with a notable complication risk. Our investigation showed that a new device for generator replacement resulted in significantly reduced procedure time and length of hospital stay while completely avoiding lead damage, which translated into considerable cost savings in a real world setting.

PlasmaBlade versus Electrocautery for Deep Inferior Epigastric Perforator Flap Harvesting in Autologous Breast Reconstruction: A Comparative Clinical Outcome Study.

(1) Background: DIEP-based breast reconstruction necessitates wide undermining at the abdominal donor site, creating large wound areas. Flap harvesting is usually conducted using electrosurgical dissection devices. This study sought to compare the clinical outcomes in patients after using the PEAK PlasmaBlade (PPB) versus monopolar electrocautery (MPE). (2) Methods: This retrospective cohort study included 128 patients with DIEP-based breast reconstruction. Patient characteristics and information on the postoperative course were collected and a comparative evaluation was conducted. (3) Results: The MPE group exhibited significantly (p* = 0.0324) higher abdominal drainage volume (351.11 ± 185.96 mL) compared to the PPB group (279.38 ± 183.38 mL). A subgroup analysis demonstrated that PPB significantly reduced postoperative wound fluid in patients with BMI > 30 kg/m2 (p* = 0.0284), without prior neoadjuvant chemotherapy (p** = 0.0041), and among non-smokers (p = 0.0046). Furthermore, postoperative pain was significantly (p**** < 0.0001) lower in the PPB cohort. (4) Conclusions: This study confirms the non-inferiority of the PEAK PlasmaBlade to conventional electrocautery for abdominal flap harvesting. The PPB demonstrated advantages, notably reduced drainage volume and lower postoperative pain levels. Recognizing patient subsets that benefit more from the PPB highlights the importance of personalized device selection based on patient characteristics.

Use of PEAK PlasmaBlade in implant-based breast reconstruction and radiotherapy: new strategy to reduce complications.

BACKGROUND: Implant-based breast reconstruction in the setting of radiotherapy often leads to higher complications rates (mainly capsular contracture and wound dehiscence) and poor cosmetic outcomes. We hypothesized that the combination of pulsed-electron avalanche knife (PEAK) PlasmaBlade (a pulsed radiofrequency electrosurgery) and acellular dermal matrix Veritas® in postmastectomy radiotherapy implant-based breast reconstruction could result in lower complications rate, better reconstructive results, and patient satisfaction. METHODS: A prospective observational study focused on the use of PEAK PlasmaBlade in implant-based breast reconstruction and radiotherapy was carried out in the Plastic Reconstructive Surgery Unit at Fondazione IRCCS Istituto Nazionale Tumori Milano between December 2017 and 2019 (2017-2018: enrollment; 2018-2019: follow-up). Patient demographics were queried and complication rates and patient and surgeon satisfaction were assessed. RESULTS: A total of 88 patients were enrolled; 2 patients received bilateral reconstruction, leading to a total of 90 procedures. Sixty-two women received contralateral symmetrization. Seroma was the most frequent minor complication (8.8%); implant exposure was the most recorded among major complications (5.5%). Preoperative lipofilling was the most substantial protective factor for preventing complications (p < 0.001). A significant association between capsular thermal damage thickness and the type of electrosurgery used (traditional electrosurgery vs PEAK PlasmaBlade) was observed, with lower values with PEAK PlasmaBlade (p < 0.0001). CONCLUSIONS: Our protocol results in low rates of surgical complications and a high level of patient and surgeon satisfaction although longer follow-up is needed.

Comparison of PEAK PlasmaBlade™ to conventional diathermy in abdominal-based free-flap breast reconstruction surgery-A single-centre double-blinded randomised controlled trial.

BACKGROUND: Electrosurgery makes dissection with simultaneous haemostasis possible. The produced heat can cause injury to the surrounding tissue. The PEAK PlasmaBlade™(PPB) is a new electrosurgery device which may overcome this by having the ability to operate on a lower temperature, therefore reducing collateral thermal damage. METHOD: A single-centre, double-blinded, randomised controlled trial (RCT) was conducted which included 108 abdominal-based free-flap breast reconstruction patients who had their flap raise performed using either the PPB (n = 56) or the conventional diathermy (n = 52). Data were collected during their in-patient stay and out-patient appointments. The primary outcome value was the number of days the abdominal drains were required. RESULTS: Baseline characteristics were similar between the groups, except a significantly lower flap weight in the PPB group. The median number of days the drains were required did not differ significantly (p = 0.48; 6.0 days for the diathermy and 5.0 days for the PPB). The total drain output (p = 0.68), the inflammatory cytokine in the drain fluid (p>0.054) and complications (p>0.24) did not differ significantly between the two groups. At the 2-week follow-up appointment, there was a trend towards less abdominal seromas on abdominal ultrasound (p = 0.09) in the PPB group which were significantly smaller (p = 0.04). CONCLUSION: The use of the PPB did not result in a significant reduction of drain requirement, total drain output or inflammatory cytokines but did reduce the size of seroma collections at the 2-week follow-up appointment. Therefore, the use of the PPB device could reduce early seroma formation after drain removal.

Plasma Technology Reduces Blood Loss in Adolescent Idiopathic Scoliosis Surgery: A Prospective Randomized Clinical Trial.

STUDY DESIGN: Prospective randomized clinical trial. OBJECTIVES: To assess the effectiveness of PEAK Plasmablade (PPB), compared with bipolar sealer and standard electrocautery, in the posterior spinal instrumentation and fusion (PSF) surgery performed for adolescent idiopathic scoliosis (AIS). METHODS: Ninety-three patients undergoing PSF surgery for AIS were randomized in 2 groups: group-A patients (n = 45) underwent PSF surgery using PPB; group-B patients (n = 48) were treated with bipolar sealer and standard electrocautery. Demographic and surgical data was recorded. All the patients underwent serial blood tests on the day before surgery (T0) and at 24 (T1), 48 (T2), 72 (T3), and 96 (T4) hours postoperatively. Visual analogue scale for pain (VAS) score, the percentage of paracetamol assumption, and the blood transfusion rate were recorded in the time-lapse T1 to T4. Intergroup variability was assessed. Pearson correlation test was performed. A P value <.05 was considered significant. RESULTS: In group A, a significantly shorter total operative time (P = .0087), a significantly lower total intraoperative blood loss (TBL) (P = .001), and a higher postoperative hemoglobin (Hb) (P = .01) were recorded. A significant higher mean Hb concentration and mean albumin value was recorded in group A at 24 and 48 hours postoperatively. A significant correlation between TBL and hospital stay was recorded in both groups (group A, P = .00 001; group B, P = .00 006); moreover, in both groups, a significant correlation was observed between TBL and mean VAS at 72 hours postoperatively (group A, P = .0009; group B, P = .0001) and at 96 hours postoperatively (group A, P = .000 044; group B, P = .00 001). CONCLUSIONS: PPB reduces the intraoperative blood loss in PSF performed for AIS, thus allowing a patient's faster recovery.

The use of plasmakinetic cautery compared to conventional electrocautery for dissection of abdominal free flap for breast reconstruction: single-centre, randomized controlled study.

BACKGROUND: The plasmakinetic cautery is a surgical dissection instrument that combines scalpel-like cutting precision with electrocautery-like haemostasis properties, and operates at lower temperatures (40-170 °C) than conventional electrocautery (200-350 °C). The aim of this study is to evaluate the clinical benefits of using plasmakinetic cautery in abdominal free flap dissection for breast reconstruction. METHODS: Forty women undergoing abdominal-based microsurgical breast reconstruction (DIEP/MS-TRAM) were randomized to plasmakinetic cautery (n=20) or conventional electrocautery (n=20) for dissection of the abdominal free flap. Total abdominal wound drainage volume/duration, operation time and complications such as seroma and haematoma were examined. RESULTS: Age, body mass index, type of reconstruction and abdominal flap weight were similar in both groups. Mean abdominal drainage volume was (279±262) mL in conventional electrocautery group and (294±265) mL in plasmakinetic cautery group (P=0.853). Plasmakinetic cautery group mean drainage duration (4.3±2.2 days) was no difference compared to conventional diathermy group (3.8±2.0 days, P=0.501). Mean operation time in the conventional electrocautery group and plasmakinetic cautery group was 157±50 vs. 174±70 min respectively (P=0.195). There was more seroma detected in the conventional electrocautery group compared to plasmakinetic cautery group at days 7, 14 and 42 post-operation, but this was not statically significant. 2 haematomas in conventional diathermy group and 1 haematoms in the plasmakinetic cautery group required evacuation. CONCLUSIONS: This study demonstrates that there are no significant differences between the use of plasmakinetic cautery and conventional electrocautery for abdominal free flap dissection.

Use of pulsed electron avalanche knife (PEAK) PlasmaBlade™ in patients undergoing implantation of subcutaneous implantable cardioverter-defibrillator.

INTRODUCTION: Surgical implantation of subcutaneous implantable cardioverter-defibrillators (S-ICD) requires preparation of a deeper and larger pocket. Infection and bleeding complications are reported, particularly in patients requiring antiplatelet therapy (APT) or being on oral anticoagulation (OAC), with rates up to 25%. The pulsed electron avalanche knife (PEAK) PlasmaBlade™ has been reported to reduce bleeding complications. The purpose of this study was to evaluate the safety and feasibility of a PEAK guided S-ICD implantation with respect to perioperative complications. METHODS AND RESULTS: We enrolled 36 consecutive patients (75% male; mean age 52.1 ±â€¯14.4 years) undergoing S-ICD implantation. Periprocedural safety endpoints comprised major complications including pocket hematomas, wound infections, bleeding (BARC ≥2) or events requiring interventions. Patients were divided into three groups according to management of their anticoagulation: i.) APT, n = 15 (41.7%); ii.) OAC, n = 10 patients (27.8%); iii.) none (neither OAC nor APT), n = 11 (30.6%). Mean procedure duration was 33.1 ±â€¯13.4 min. Mean length of hospital stay was 3.3 ±â€¯2.1 days. Overall analysis showed no differences between the 3 groups with respect to major complications, major bleeding episodes or other procedural parameters, beside a trend towards more minor hematomas in the OAC group (OAC: 22.2% vs. APT: 11.4% vs. none: 9.1%; p = 0.15). CONCLUSION: The results of our pilot study suggest that intermuscular S-ICD implantation using PEAK is safe and potentially beneficial in patients receiving OAC or APT with respect to prevention of bleeding complications. These results support the rationale for large prospective controlled trials evaluating a beneficial effect of PEAK use in S-ICD implantation procedures.

Pulsed electron avalanche knife (PEAK) PlasmaBlade™ in pacemaker and defibrillator procedures.

BACKGROUND: The pulsed electron avalanche knife (PEAK) PlasmaBlade™ is an innovative electrosurgical device that uses a novel technology to cut tissues. It has been proven to be safe and feasible in ear, nose, and throat surgery, but there are only limited data concerning the use of PlasmaBlade™ instead of conventional electrocautery in cardiac implantable electronic device (CIED) procedures except for generator replacements. METHODS: We conducted a retrospective, single-center study with patients undergoing CIED surgery at our center between December 2015 and March 2017 and evaluate the feasibility and the clinical outcome of the PlasmaBlade™. RESULTS: 282 patients (mean age 70.7 ±  12.9 years; 65.6% male) were included, of which 119 (42.2%) underwent pacemaker implantation, 95 (33.7%) implantable cardioverter defibrillator implantation, and 68 (24.1%) received a generator replacement. At the time of the procedure, 55 patients (19.5%) were on dual antiplatelet therapy, and 109 (38.7%) patients were on oral anticoagulation (30.5% vitamin K antagonists, 8.2% novel oral anticoagulants). The overall perioperative complication rate was 3.9%. Device-pocket hematoma occurred in 9 patients (3.2%) requiring further surgery. No lead damage was seen within a follow-up of 6 months. One patient presented with device-pocket infection 2.9 months after implantation of a cardiac resynchronization therapy defibrillator requiring CIED system extraction. CONCLUSIONS: Replacing conventional electrocautery by PlasmaBlade™ for CIED procedures is feasible with a moderate rate of perioperative complications compared to the literature. Studies comparing the PlasmaBlade™ with conventional electrocautery are necessary to investigate whether PlasmaBlade™ offers an additional benefit over conventional electrocautery.