scholarly journals Comparison of Electrocautery Platforms for Pulse Generator Replacement Procedures

Author(s):  
Caleb Chiang ◽  
Muhammad Ayub ◽  
Kousik Krishnan ◽  
Richard Trohman ◽  
Parikshit Sharma ◽  
...  

Introduction: Lead damage can occur during cardiovascular implantable electronic device (CIED) generator replacement procedures, resulting in additional procedures and added costs. PlasmaBlade (PL) and PhotonBlade (PH) are two commercially available insulated electrocautery devices designed to reduce this risk. Objective: This study compared complication rates of PL and PH in CIED generator replacement procedures. Methods: This retrospective study analyzed transvenous CIED generator replacements using PL or PH from 2017-2020. The primary endpoint was lead damage. Secondary endpoints included rate of pocket hematoma, superficial infection, and infections requiring device removal. Results: A total of 209 patients were included for analysis, including 86 procedures (188 leads) using PL and 123 procedures (266 leads) using PH. Lead insulation material consisted of 237 (52.2%) silicone, 66 (14.5%) polyurethane, and 151 (33.3%) copolymer leads, with no significant difference in frequency of insulation materials (p=0.91). The rate of lead damage was low for both PL and PH (0 vs. 0.4%, p=0.59). There was no significant difference in pocket hematoma (1.2% vs. 1.6%, p=0.43), superficial infection (1.2% vs. 0.8%, p=0.49), or infection requiring device removal (1.2% vs. 0%, p=0.41). The mean absolute change in lead impedance from pre- to post-procedure was similar between PL and PH (72.3 ± 126.1 ohms vs. 60.6 ± 72.3 ohms, p=0.10). Conclusions: There was a low rate of complications after CIED replacement procedures, with no significant difference between the PL and PH groups. A majority of leads with silicone insulation material may have contributed to the low rate of lead damage.

Circulation ◽  
2014 ◽  
Vol 130 (suppl_2) ◽  
Author(s):  
Takanori Takahashi ◽  
Junichi Shimotakahara ◽  
Nobuhito Yagi ◽  
Jun Nakazato ◽  
Tadayoshi Miyagi ◽  
...  

Introduction: Cardiovascular Implantable Electronic Device(CIED) Infections are one of the most serious complication after CIED implantation or replacement. To prevent infection, appropriate skin antisepsis and perioperative antibiotic prophylaxis at CIED implantation/replacement are important. But the most optimal antisepsis for CIED surgery is not well defined. Then we assessed whether additional wiping of the skin with 70% isopropyl alcohol just before routine skin antisepsis with povidone-iodine reduces the incidence of CIED infection. Methods: Consecutive 473 cases of CIED implantation or generator replacement from Jan.2008 to Dec.2013 at one community hospital were divided into two groups according to preoperative skin antisepsis with 70% isopropyl alcohol wipes lasting for at least 1 minute just before povidone-iodine scrub and paint(IPA group, n=183), or povidone-iodine only(No IPA group, n=290). All cases received perioperative antibiotic prophylaxis 30 minute before and 6 hours after procedure. Incidence of CIED infection requiring complete extraction of the leads and the generator within 1-year after implantation/replacement were compared between two groups by Kaplan-Meier analysis. Results: There were no significant difference in background CIED infection risk factors identified by past studies (diabetes, renal insufficiency, anticoagulant use, corticosteroid use, tempolary pacing, and generator replacement) between two groups. During the follow up period, 8 cases of confirmed CIED infection requiring complete extraction were identified, 6 pacemaker and 2 implantable cardioverter-defibrillator(ICD) or biventricular ICD. All infected cases belonged to No IPA group (p = 0.0235). Conclusions: In conclusion, wiping of the skin with 70% isopropyl alcohol just before routine antisepsis with povidone-iodine at CIED implantation/replacement significantly reduces the incidence of infection.


2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
K Anusonadisai ◽  
A Suwanagool

Abstract Background Each year, 1.65 million people around the world are implanted with Cardiac Implantable Electronic Devices [CIEDs], which our center, performed about 300–350 cases per year. These implantation process needs expertise and specializes in preventing the complication. Some complications, such as device-related bleeding complications (DRBCs) and pocket hematoma, especially in those patients receiving oral antithrombotic drugs before the surgery, should be preventable. Based on our observation of cases in the operation room, the wounds which were easily bleed can effectively create hemostasis by using adrenaline-packed dressing. The purpose of this study is to explore if the adrenaline pack dressing could reduce bleeding complications and reduce pocket hematoma in patients undergoing CIED implantation. Purpose To evaluate if adrenaline-packed dressing during CIED implantation can demonstrate a reduction in bleeding complication. Methods This is a single-center double-blind, randomized control study that included most of the patients undergoing CIED implantation in our center from June 2019 to Jan 2020. The patients will be randomized to adrenaline-packed dressing or matched control group. The protocol requires each patient to have a 2-weeks evaluation at the device clinic by two device-clinic staff. If DRBCs are detected, we used a caliper to measure the size in the largest dimension. Our primary outcome is the incidence of DRBCs at 2-weeks. Results There were 165 patients enrolled from June 2019 to Jan 2020. Mean age was 73 (female 52%), 24% on antiplatelet, 36% on anticoagulant. The pocket hematoma and ecchymosis at the 2-week was 15.8% and 15.2%, respectively. The DRBCs at 2-weeks was not significantly different between groups (22.6% vs. 33.3%; p=0.125). However, the next morning hematoma was significantly decreased in the adrenaline-packed dressing group (13.1% vs. 28.4%; p=0.015). The trend of subgroup analysis in the adrenaline pack dressing group was showing a reduction of DRBCs in patients who on anticoagulation therapy. Conclusion The adrenaline pack dressing appears to reduce early pocket hematoma significantly, but at two weeks, most of them were resolved and make no significant difference between groups. Funding Acknowledgement Type of funding source: None


2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
C E P Brough ◽  
D J Wright

Abstract Background The rate of implantation of cardiac rhythm management devices continues to increase but it is difficult to compare the complication rates of routine cardiac implantable electronic device procedures as the follow-up durations published in literature vary widely (peri-procedure to 3 years). Purpose We demonstrate the appropriate follow-up duration for a complication to be attributed to an index procedure, by analysing the complications within the first year of routine cardiac implantable electronic device procedures (primary implant, generator replacement, lead revision only, generator and lead revision, system upgrade and reburial) and the timing of complication interventions. Methods A retrospective database was constructed of all de novo CIED operations performed at a tertiary cardio-thoracic centre between April 2008 – March 2016. Procedures were identified from theatre logbooks, with demographic and procedural data extracted from contemporaneously maintained health records (paper and electronic). Objective complications were defined as follows; 1. Any pneumothorax identified on chest x-ray, 2. Any pericardial effusion identified on transthoracic echocardiogram performed post procedure due to intra-operative clinical concern, 3. Haematoma requiring surgical evacuation, 4. Device pocket revision or system reburial, 5. Lead intervention requiring repositioning or placement of a new lead and 6. System explant/ extraction due to any indication. Post-operative complications were identified through theatre log books and cross-referenced with 3 contemporaneously maintained records (clinical health records, TOMCAT electronic database, audit department archive). All data collection was performed by a single investigator, independent of the procedures performed and operating physicians. Results 10,125 procedures were reviewed; 6,583 primary implant procedures, 2,170 generator replacements, 382 lead revisions, 253 generator and lead interventions, 575 system upgrades and 162 reburial procedures. The procedures involved 3,403 female patients and 6,722 male, with a median age 73 years (±13.7). 2,303 procedures were acute and 7,822 elective. The complication rates were; 4.3% primary implant, 4.0% generator replacements, 12.6% lead revisions, 13.0% generator and lead interventions, 6.9% system upgrades and 22.8% reburial procedures. The timing of complication intervention varied significantly (Figure 1). Timing of Complication Intervention Conclusion Complications within the first year of any cardiac implantable electronic device intervention is common, particularly system reburials, lead revisions and generator and lead procedures. 10% of complications after generator replacement, system upgrades or reburial procedures occurred at between 36–52 weeks. For lead and combined generator and lead procedures this figure rose to approximately 15%.


2020 ◽  
Vol 49 (3) ◽  
pp. E11 ◽  
Author(s):  
Yoshifumi Kudo ◽  
Ichiro Okano ◽  
Tomoaki Toyone ◽  
Akira Matsuoka ◽  
Hiroshi Maruyama ◽  
...  

OBJECTIVEThe purpose of this study was to compare the clinical results of revision interbody fusion surgery between lateral lumbar interbody fusion (LLIF) and posterior lumbar interbody fusion (PLIF) or transforaminal lumbar interbody fusion (TLIF) with propensity score (PS) adjustments and to investigate the efficacy of indirect decompression with LLIF in previously decompressed segments on the basis of radiological assessment.METHODSA retrospective study of patients who underwent revision surgery for recurrence of neurological symptoms after posterior decompression surgery was performed. Postoperative complications and operative factors were evaluated and compared between LLIF and PLIF/TLIF. Moreover, postoperative improvement in cross-sectional areas (CSAs) in the spinal canal and intervertebral foramen was evaluated in LLIF cases.RESULTSA total of 56 patients (21 and 35 cases of LLIF and PLIF/TLIF, respectively) were included. In the univariate analysis, the LLIF group had significantly more endplate injuries (p = 0.03) and neurological deficits (p = 0.042), whereas the PLIF/TLIF group demonstrated significantly more dural tears (p < 0.001), surgical site infections (SSIs) (p = 0.02), and estimated blood loss (EBL) (p < 0.001). After PS adjustments, the LLIF group still showed significantly more endplate injuries (p = 0.03), and the PLIF/TLIF group demonstrated significantly more dural tears (p < 0.001), EBL (p < 0.001), and operating time (p = 0.04). The PLIF/TLIF group showed a trend toward a higher incidence of SSI (p = 0.10). There was no statistically significant difference regarding improvement in the Japanese Orthopaedic Association scores between the 2 surgical procedures (p = 0.77). The CSAs in the spinal canal and foramen were both significantly improved (p < 0.001).CONCLUSIONSLLIF is a safe, effective, and less invasive procedure with acceptable complication rates for revision surgery for previously decompressed segments. Therefore, LLIF can be an alternative to PLIF/TLIF for restenosis after posterior decompression surgery.


2021 ◽  
Author(s):  
Jakrin Kewcharoen ◽  
Chanavuth Kanitsoraphan ◽  
Sittinun Thangjui ◽  
Thiratest Leesutipornchai ◽  
Sakditad Saowapa ◽  
...  

2021 ◽  
Vol 10 (10) ◽  
pp. 2054
Author(s):  
Gerasimos Kopsinis ◽  
Dimitrios Tsoukanas ◽  
Dimitra Kopsini ◽  
Theodoros Filippopoulos

Conjunctival wound healing determines success after filtration surgery and the quest for better antifibrotic agents remains active. This study compares intracameral bevacizumab to sub-Tenon’s mitomycin C (MMC) in trabeculectomy. Primary open-angle or exfoliative glaucoma patients were randomized to either bevacizumab (n = 50 eyes) or MMC (n = 50 eyes). The primary outcome measure was complete success, defined as Intraocular Pressure (IOP) > 5 mmHg and ≤ 21 mmHg with a minimum 20% reduction from baseline without medications. Average IOP and glaucoma medications decreased significantly in both groups at all follow-up points compared to baseline (p < 0.001), without significant difference between groups at 3 years (IOP: bevacizumab group from 29 ± 9.4 to 15 ± 3.4 mmHg, MMC group from 28.3 ± 8.7 to 15.4 ± 3.8 mmHg, p = 0.60; Medications: bevacizumab group from 3.5 ± 0.9 to 0.5 ± 1, MMC group from 3.6 ± 0.7 to 0.6 ± 1.1, p = 0.70). Complete success, although similar between groups at 3 years (66% vs. 64%), was significantly higher for bevacizumab at months 6 and 12 (96% vs. 82%, p = 0.03; 88% vs. 72%, p = 0.04, respectively) with fewer patients requiring medications at months 6, 9 and 12 (4% vs. 18%, p = 0.03; 6% vs. 20%, p = 0.04; 8% vs. 24%, p = 0.03, respectively). Complication rates were similar between groups. In conclusion, intracameral bevacizumab appears to provide similar long-term efficacy and safety results as sub-Tenon’s MMC after trabeculectomy.


2021 ◽  
Vol 09 (01) ◽  
pp. E9-E13
Author(s):  
Sachin Srinivasan ◽  
Peter D. Siersema ◽  
Madhav Desai

Abstract Background and study aims Diminutive colorectal polyps are increasingly being detected and it is not clear whether jumbo biopsy forceps (JBF) has comparable efficacy to that of cold snare polypectomy (CSP) for management of these lesions. Methods An electronic literature search was performed for studies comparing resection rates of JBF and CSP for diminutive polyps (≤ 5 mm). The primary outcome was incomplete resection rate (IRR). Secondary outcomes included failure of tissue retrieval and complication rates (post-polypectomy bleeding, perforation etc.). Leave-one-out analysis was performed to examine the disproportionate role of any of the studies. Meta-analysis outcomes and heterogeneity (I2) were computed using Comprehensive meta-analysis software. Results A total of 4 studies (3 randomized controlled trials and 1 retrospective study) with 407 patients and 569 total polyps (mean size of 3.62 mm) was included for analysis. IRR of JBF was slightly higher than that of CSP (10.2 % vs 7.2 %) but this was not statistically significantly different (Pooled OR 1.76; 95 % CI 0.94–3.28; I2 = 0). Leave-one-out analysis showed no significant difference in the pooled OR comparison either. Two of the 4 studies reported 0 % failure of tissue retrieval for JBF and 1 % and 4.3 % for CSP. There were no complications for either group from the 2 studies that reported this outcome. The quality of the included studies was moderate to high. Conclusions This systematic review with only limited data shows that JBF and CSP are not statistically different in completely removing diminutive polyps, although careful endoscopic assessment is needed to ensure complete removal of all polyp tissue.


Author(s):  
Istvan Bence Balint ◽  
Ferenc Csaszar ◽  
Krisztian Somodi ◽  
Laszlo Ternyik ◽  
Adrienn Biro ◽  
...  

Abstract Purpose Based on recent scientific evidence, bariatric surgery is more effective in the management of morbid obesity and related comorbidities than conservative therapy. Pylorus preserving surgical procedures (PPBS) such as laparoscopic single-anastomosis duodeno-jejunal or duodeno-ileal bypass with sleeve gastrectomy are modified duodenal switch (DS) surgical techniques. The duodeno-jejunal bypass liner (DJBL) is a novel surgical method in the inventory of metabolism focused manual interventions that excludes duodeno-jejunal mucosa from digestion, mimicking DS procedures without the risk of surgical intervention. The aim of this article is to summarize and compare differences between safety-related features and weight loss outcomes of DJBL and PPBS. Methods A literature search was conducted in the PubMed database. Records of DJBL-related adverse events (AEs), occurrence of PPBS-related complications and reintervention rates were collected. Mean weight, mean body mass index (BMI), percent of excess of weight loss (EWL%), percent of total weight loss (TWL%) and BMI value alterations were recorded for weight loss outcomes. Results A total of 11 publications on DJBL and 6 publications on PPBS were included, involving 800 and 1462 patients, respectively. The baseline characteristics of the patients were matched. Comparison of DJBL-related AEs and PPBS-related severe complications showed an almost equal risk (risk difference (RD): −0.03 and confidence interval (CI): −0.27 to 0.21), despite higher rates among patients having received endoscopic treatment. Overall AE and complication rates classified by Clavien-Dindo showed that PPBS was superior to DJBL due to an excess risk level of 25% (RD: 0.25, CI: 0.01–0.49). Reintervention rates were more favourable in the PPBS group, without significant differences in risk (RD: −0.03, CI: −0.27 to 0.20). However, PPBS seemed more efficient regarding weight loss outcomes at 1-year follow-up according to raw data, while meta-analysis did not reveal any significant difference (odds ratio (OR): 1.08, CI: 0.74–1.59 for BMI changes). Conclusion Only limited conclusions can be made based on our findings. PPBS was superior to DJBL with regard to safety outcomes (GRADE IIB), which failed to support the authors’ hypothesis. Surgical procedures showed lower complication rates than the incidence of DJBL-related AEs, although it should be emphasized that the low number of PPBS-related mild to moderate complications reported could be the result of incomplete data recording from the analysed publications. Weight loss outcomes favoured bariatric surgery (GRADE IIB). As the DJBL is implanted into the upper gastrointestinal tract for 6 to 12 months, it seems a promising additional method in the inventory of metabolic interventions.


2021 ◽  
pp. 1-7
Author(s):  
Gamze Aytaş ◽  
Rümeyza Kazancıoğlu ◽  
Ömer C. Elçioğlu ◽  
Meltem Gürsu ◽  
A. Serra Artan ◽  
...  

<b><i>Introduction:</i></b> Orthostatic hypotension (OH) affects 5–20% of the population. Our study investigates the presence of OH in diabetic nephropathy (DNP) patients and the factors affecting OH in comparison with nondiabetic chronic kidney disease (NDCKD) patients. <b><i>Method:</i></b> Patients presented to the nephrology clinic, and those who consented were included in the study. DNP was defined by kidney biopsy and/or clinical criteria. NDCKD patients of the same sex, age, and eGFR were matched to DNP patients. Demographic parameters and medications were obtained from the records. OH was determined by Mayo clinic criteria. The same researcher used an electronic device to measure blood pressure (BP). All samples were taken and analyzed the same day for biochemical and hematologic parameters and albuminuria. <b><i>Results:</i></b> 112 (51 F, 61 M, mean age: 62.56 ± 9.35 years) DNP and 94 (40 F, 54 M, mean age: 62.23 ± 10.08 years) NDCKD patients were included. There was no significant difference between DNP and NDCKD groups in terms of OH prevalence (70.5 vs. 61.7%, <i>p</i> = 0.181). Male patients had significantly higher OH prevalence than female patients (74.7 vs. 60.0%, <i>p</i> = 0.026). There was no significant difference in change in systolic BP between the groups (24.00 [10.00–32.00] mm Hg vs. 24.00 [13.75–30.25] mm Hg, <i>p</i> = 0.797), but the change in diastolic BP was significantly higher in the DNP group (8.00 [2.00–13.00] mm Hg vs. 6.00 [2.00–9.00] mm Hg, <i>p</i> = 0.025). In the DNP group, patients with OH had significantly higher uric acid levels than those without OH (7.18 ± 1.55 vs. 6.36 ± 1.65 mg/dL, <i>p</i> = 0.017). And, 73.7% of patients on calcium channel blockers developed OH (<i>p</i> = 0.015), and OH developed in 80.6% of 36 patients on alpha-blockers (<i>p</i> = 0.049). <b><i>Conclusion:</i></b> OH prevalence is very high in CKD, and etiology of CKD does not have a statistically significant effect on the frequency of OH, despite a difference that could be meaningful clinically. Therefore, patients with CKD are checked for OH, with or without concurrent diabetes mellitus. Evaluation of postural BP changes should be a part of nephrology practice.


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