Pocket Hematoma Research Articles

Predictors of Long-Term Infections After Cardiac Implantable Electronic Device Surgery - Utility of Novel PADIT and PACE DRAP Scores.

Cardiac implantable electronic device-related infections (CDI) are of increasing importance and involve substantial healthcare resources. This study aimed to evaluate potential CDI risk factors and the utility of the novel PADIT and PACE DRAP scores to predict CDI. The study group included 1,000 consecutive patients undergoing implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy (CRT) surgery. Patients' and procedural characteristics were collected. CDI occurrence was assessed during 1-year follow-up. Moreover, if periprocedural significant pocket hematoma (SPH) occurred, the maximal volume was calculated based on ultrasonographic measurements and ABC/2 formula. The overall incidence of CDI was 1.8%. In the multivariable regression analysis independent CDI risk factors were: age >75 years (odds ratio [OR]: 5.93; 95% confidence interval [CI]: 1.77-19.84), system upgrade procedure (OR: 6.46; CI: 1.94-21.44), procedure duration >1 h (OR: 13.96; CI: 4.40-44.25), presence of SPH (OR: 4.95; CI: 1.62-15.13) and reintervention within 1 month (OR: 16.29; CI: 3.14-84.50). The PACE DRAP score had higher discrimination of CDI incidence (area under curve [AUC] 0.72) as compared with the PADIT score (AUC 0.63). We identified 5 independent risk factors of CDI development. Our study also showed that the PACE DRAP score was better able to identify patients at high risk of CDI than the PADIT score.

Cardiovascular Implantable Electronic Device Surgery Following Left Ventricular Assist Device Implantation.

This study sought to determine the indications, characteristics, and outcomes of cardiovascular implantable electronic device (CIED) surgery in patients with LVAD. Many patients with a left ventricular assist device (LVAD) will require implantable cardioverter-defibrillator generator change or device revision or are candidates for de novo implantable cardioverter-defibrillator implantation following LVAD implantation. We performed an observational retrospective study of all LVAD recipients who subsequently underwent CIED surgery at Duke University Hospital from 2009 to2019. A total of 159 patients underwent CIED surgery following LVAD implantation, including generator change (n=93), device revision (n=38), and de novo implant (n=28). The median (interquartile range) time from LVAD implantation to CIED surgery was 18.1 months (5.5 to 35.1 months). Pre-operative risk for infection was elevated in the overall cohort with a median (interquartile range) Prevention of Arrhythmia Device Infection Trial (PADIT) score of 7.0 (5.0 to 9.0). Pocket hematoma occurred in 21 patients (13.2%) following CIED surgery. Antimicrobial envelops were used in 43 patients (27%). Device infection due to CIED surgery occurred in 5 (3.1%) patients and occurred only in patients who developed post-operative pocket hematoma (p<0.001). Mortality at 1 year following CIED surgery was 20% (n=32). CIED surgery following LVAD implantation is associated with an increased risk for pocket hematomaand CIED infection. Further studies are needed to determine the risk-benefit ratio of CIED surgery in patients withLVADs.

Implementation of a Hepatic Artery Infusion Program: Initial Patient Selection and Perioperative Outcomes of Concurrent Hepatic Artery Infusion and Systemic Chemotherapy for Colorectal Liver Metastases.

Hepatic artery infusion (HAI) combined with systemic chemotherapy is a treatment strategy for patients with unresectable liver-only or liver-dominant colorectal liver metastases (CRLM). Although HAI has previously been performed in only a few centers, this study aimed to describe patient selection and initial perioperative outcomes during implementation of a new HAI program. The study enrolled patients with CRLM selected for HAI after multi-disciplinary review November 2018-January 2020. Demographics, prior treatment, and perioperative outcomes were assessed. Objective hepatic response was calculated according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. During a 14-month period, 21 patients with CRLM underwent HAI pump placement. Of these 21 patients, 20 (95%) had unresectable disease. Most of the patients had synchronous disease (n = 18, 86%) and had received prior chemotherapy (n = 20, 95%) with extended treatment cycles (median 16; interquartile range, 8-22; range, 0-66). The median number of CRLMs was 7 (range, 2-40). Operations often were performed with combined hepatectomy (n = 4, 19%) and/or colectomy/proctectomy (n = 11, 52%). The study had no 90-day mortality. The overall surgical morbidity was 19%. The HAI-specific complications included pump pocket seroma (n = 2), hematoma (n = 1), surgical-site infection (n = 1), and extrahepatic perfusion (n = 1). HAI was initiated in 20 patients (95%). The hepatic response rates at 3months included partial response (n = 4, 24%), stable disease (n = 9, 53%), and progression of disease (n = 4, 24%), yielding a 3-month hepatic disease control rate (DCR) of 76%. Implementation of a new HAI program is feasible, and HAI can be delivered safely to selected patients with CRLM. The initial response and DCR are promising, even for patients heavily pretreated with chemotherapy.

Hybrid transvenous lead extraction during cardiac surgery for valvular endocarditis.

In patients with endocarditis and cardiac implantable electronic devices (CIED), lead extraction is recommended according to current guidelines. In patients with short lead implant duration, lead extraction by manual traction might be sufficient for intraoperative lead removal. However, in patients with long implant duration, specialized extraction tools like laser or mechanical rotational sheaths are necessary. We report our experience with transvenous lead extraction during concomitant cardiac surgery for valvular endocarditis using mechanical rotational sheaths. Between December 2018 and April 2020, 12 patients were treated with transvenous lead extraction during open-heart surgery using mechanical rotational sheaths. Cardiac surgery was performed due to mitral, aortic, or tricuspid valve endocarditis. All patient-related and procedural data were collected, and in-hospital outcome was analyzed retrospectively. Mean patients' age was 65.2 ± 16.4 years, and 75.0% were male. Nine atrial, 15 ventricular, and 2 coronary sinus leads had to be extracted. The mean time from initial lead implantation was 94.3 ± 39.7 months. Complete procedural success was achieved in all patients with no major but one minor complication (pocket hematoma) occurring during lead extraction. Four patients with pacemaker dependency received epicardial leads, seven patients were treated in a two-step approach with endocardial leads, whereas one patient had no further CIED indication. No procedure-related mortality was seen. In-hospital survival was 91.7%. Valvular endocarditis surgery in combination with lead extraction using mechanical rotational sheaths is safe and feasible. It results in a high procedural success rate with prompt infection control by immediate removal of all infected lead materials.

848Ultrasound-guided axillary vein puncture feasibility for complex cardiac devices implantation

Abstract Background The axillary route use for cardiac devices implantation has recently expanded either with fluoroscopy or ultrasounds guidance. Few studies included defibrillators (ICD), cardiac resynchronization therapy (CRT) and upgrade procedures for ultrasound-guided axillary vein puncture (UGVP). Puropose To assess the feasibility/safety of UGVP for complex cardiac devices implantation including CRT/ICD. Methods Consecutive patients eligible for a pacemaker or ICD implantation were included. All procedures were performed by three operators (one experienced and two fellows). Guidewires insertion time (from lidocaïne administration), and complications were systematically studied. A group of patients implanted with alternative techniques was used for comparison (cephalic, subclavian). Results In 176 consecutive patients in whom UGVP was used, a total of 68 complex procedures were analyzed (74 ± 8 y, male 61 %) with 138 leads implanted including 42 ICD, 48 CRT and 16 upgrade procedures. A majority (83 %) was under anti-thrombotic therapy. UGVP was successful in 96.8 %. Mean insertion time for 1.78 guidewires per patient was 4.4 ± 4.4 min. Guidewires insertion time reached its plateau after 10 patients. One pocket hematoma (1.4 %) was drained during a mean follow-up of 12 ± 5 months. The control group included 28 patients (12 subclavian, 16 cephalic; 15 ICD, 18 CRT, 4 upgrade procedures), with a mean insertion time of 10 ± 8 min, for 1.95 guidewires per patient (p &amp;lt; 0.0005). Conclusion UGVP is feasible and safe even for complex device implantations including CRT/ICD and upgrade procedures.

P1187Pocket-Hematoma after cardiac implantable electronic devices surgery: a single centre study

Abstract Intro Pocket hematoma is a common complication after pacemaker (PMK) or implantable cardioverter defibrillator (ICD) surgery. In this clinical setting anticoagulant and antiplatelet therapy are associated with an increased risk of hemorrhagic complications, but data are sparse. Purpose We examined the impact of antiplatelet therapy and anticoagulation with vitamin K antagonists (VKA) or heparin on the risk of pocket hematoma. Materials and method: between august 2017 and june 2019, a total of 639 devices were implanted or replaced at our centre. Predictors of hematoma occurrence were determined by multivariate regression analysis. We used a specific definition of pocket hematoma: a) any palpable swelling in the pocket area requiring an unscheduled visit or prolonged hospitalization &amp;gt; 24 h or re-hospitalization for hematoma, b) interruption of antithrombotics, c) reoperation, d) hemoglobin drop &amp;gt; 2 g/dl or blood transfusion. The above criteria were assessed during hospitalization and up to 10 days after discharge. Results: the incidence of pocket hematoma was 7.5%. Among 639 patients (pts) including in the study 33.5% (214 pts) didn’ t take any antithrombotic therapy, 40.2 % (257 pts) were on single antiplatelet therapy (SAPT), 8.8 % (56 pts) were on dual antiplatelet therapy, 11.1 % (71 pts) were on uninterrupted VKA (mean INR 2). Heparin bridging was administered in 6.4% (41 pts). Ejection fraction (43 ±13 %) and hemoglobin value before implantation (12.3 ±2.6 g/dL) in patients who developed hematoma were significantly lower compared with whose without hematoma. Patients with hematoma had a higher prevalence of congestive heart failure, ischemic cardiomyopathy and intake antithrombotic therapy. After adjusting for confounding factors with multivariate logistic regression only the use of dual antiplatelet therapy (OR 5.9 95% CI 1.5-21 p = 0.008) and the bridging with enoxaparin (OR 5.6 95% CI 1.4-22 p = 0.013) increased the risk of pocket hematoma. Single antiplatelet therapy (OR 2.6 95% CI 0.8-8.4 p = ns) and uninterrupted VKA (OR 0.9 95% CI 0.7-11 p = ns) did not increased the risk of pocket hematoma compared to no antithrombotic therapy. Pulse generator change and new device implant/upgrading (OR 1.8 95% CI 0.6-5.2 p = ns) carried the same haemorrhagic risk. Conclusion the use of DAPT or bridging with enoxaparin are highly predictive for the occurrence of perioperative pocket hematoma in patients scheduled for pmk/icd surgery. In contrast, single antiplatelet therapy and uninterrupted VKA did not increase the risk of hematoma.

Cardiac Implantable Electronic Device Infections in Patients with Left Ventricular Assist Devices

Cardiac implantable electronic device infections (CIED) reflect life threatening complication for LVAD patients. Despite antibiotic treatment removal or exchange of all foreign surfaces may be required for cure. However, there is limited published data and we here present to our knowledge the largest case series of CIED removal in LVAD patients. Since 2011, 161 patients underwent LVAD Implantation at our institution. We identified 7 patients who underwent infection related CIED removal and report outcome. Patient and infection characteristics, management strategy, and clinical outcomes are described. Of the 7 patients one was female; mean age was 54 years (range 42-64). Three of 7 patients had an ischemic cardiomyopathy, and 2 of 7 patients had a continuous flow LVAD placed as destination therapy. All patients presented with clinical signs of infection, lead-related endocarditis and vegetations. In one patient additional pocket infection was present. Causative pathogens included staphylococcus aureus (1), staphylococcus epidermidis (1), enterococcus faecalis (1), candida albicans (2), and culture negative (2). All patients underwent laser assisted complete CIED removal along with antimicrobial therapy. The mean implanted age of the removed leads was 5 years (2-10 years), and 3 of the 7 patients experienced a procedural complication (pocket hematoma) from CIED removal. Infection was successfully treated in all patients, except one. No re-occurrence of endocarditis was observed and no LVAD exchange was needed. One patient died within 30 days after CIED explantation due to multi organ failure and persistent sepsis. Five patients remained alive at latest follow-up with a median duration of 15 months (0.1-55 months) from the time of CIED explantation. Complete CIED removal combined with optimal antimicrobial therapy may be an effective and safe therapy for CIED infections in LVAD patients.

Predictors of infection after “de novo” cardiac electronic device implantation

BackgroundCardiac implantable electronic device (CIED) infection is a major complication that increases morbidity and mortality after the procedure. Several infection risk scores have been suggested to identify patients at higher pre-procedural risk of infection Objectivethis study sought to evaluate rates of infection, potential risk factors and the role of a modified “Shariff” score as predictor of infection in high-risk patients undergoing de novo CIED implantation. Methods and ResultsWe retrospectively analysed 1391 patients underwent a de novo CIED procedure during the study period. At the median follow-up of 48 months, 20 patients of 1391 (1.4%) developed a CIED-related infective event. In our population, we studied a modified version of the “Shariff” score for only first-time implant patients. At multivariate regression analysis, three factors were independent predictors of infection: previous pocket hematoma [RR 27.2 (8.30–54.02), p = 10−10], a Shariff Score ≥ 4 [RR 3.20 (1.29–12.59), p= 0.029]. and reintervention for catheter malfunction or dislocation [RR 3.57 (1.2–37.4), p= 0.048]. Conclusionsa “Shariff” score > 4 is suggested as a predictor of higher risk of infection in patients after de novo device implantation. The use of an infection risk score may help to improve tailored pre-operatory strategies to prevent infection.

Impact on All-Cause and Cardiovascular Mortality of Cardiac Implantable Electronic Device Complications: Results From the POINTED Registry.

This study aimed to determine how CIED-related complications affect all-cause and cardiovascular mortality over a long-term follow-up. Although complications related to implantable electronic device (CIED) implantation are steadily increasing in Europe, little is known about the impact of complications other than device infection on mortality. The POINTED (Impact on Patient Outcome and health care utilization of cardiac ImplaNTable Electronic Device complications) registry was a prospective, multicenter, observational study designed to collect data on complications in patients undergoing de novo CIED implantation (NCT03612635). All consecutive patients were enrolled in 6high-volume centers between January 2010 and December 2012 and followed up for at least 3 years. A complication was defined as any CIED-related adverse event requiring surgical revision after implantation. During follow-up (median 56.9months), we observed 283 complications in 263 of 2811 consecutive patients (71 ± 14 years of age, 66.7% men). Early complications (≤30days) were associated with significantly lower cumulative survival from cardiovascular death in comparison with late complications and with freedom from complications. On multivariate analysis, early complication, pneumothorax, and pocket hematoma were significantly associated with a higher risk of all-cause death, while device infection remained the only complication significantly associated with a higher risk of cardiovascular death. All CIED-related complications are associated with an increased risk of cardiovascular mortality, andearly complications are associated with an increased risk of all-cause mortality. These data underline the importanceof specific measures aimed at reducing CIED complications and improving their management.

Real-world evidence of pacemaker and ICD implantation in patients taking apixaban: The French AMPER-AF implantation study

Implantation of permanent pacemakers (PPMs) or implantable cardiac defibrillators (ICDs) may be complicated by the development of pocket hematomas. To evaluate bleeding complications in patients taking apixaban and undergoing a pacemaker or ICD implantation in everyday clinical practice. It is a multicenter, observational, prospective study of patients with non-valvular atrial fibrillation (AF) undergoing a pacemaker or implantable cardioverter defibrillator [ICD]. Eligible patients had been taking apixaban (2.5 or 5 mg twice daily) for ≥ 3 weeks before the procedure, and were followed for 30 days afterwards. A total of 115 patients (80 [72,85] years, 63% male, mean CHA2DS2-VASc score 3, mean HAS BLED score 3) were enrolled at 25 academic/non-academic centres in France; 68 patients (59%) were receiving apixaban 10 mg/day and 47 (41%) 5 mg/day. The most prevalent concomitant disorders were hypertension (55% of patients), diabetes (15%), vascular disease (10%) and a history of stroke (6%). Mean creatinine value was 93 ± 25 μmol/L, median weight was 83 ± 18 kg and mean creatinine clearance (Cockroft − Gault) was 82 ± 34 mL/min. The implantation was a planned procedure in 102 (89%) of cases. The mean duration of procedure was 51 min. The management of apixaban in the periprocedural period was let to the investigators preference. Median withdrawal time was 25 h. Bleeding events were detected in 4 (3.5%) cases. One of them was a pocket hematoma with infection treated by the extraction of the device. Three patients presented minor bleedings according to ISTH classification without prolongation of hospitalization. These observational data of patients on apixaban undergoing pacemaker/ICD implantation in everyday practice show a management of apixaban according to guidelines with a low rate of bleeding events.

Ultrasound-guided axillary vein puncture feasibility for complex cardiac devices implantation

The axillary route use for cardiac devices implantation has recently expanded either with fluoroscopy or ultrasounds guidance. Few studies included defibrillators (ICD), cardiac resynchronization therapy (CRT) and upgrade procedures for ultrasound-guided axillary vein puncture (UGVP). To assess the feasibility/safety of UGVP for complex cardiac devices implantation including CRT/ICD. Consecutive patients eligible for a pacemaker or ICD implantation were included. All procedures were performed by three operators (one experienced and two fellows). Guidewires insertion time (from lidocaïne administration), and complications were systematically studied. A group of patients implanted with alternative techniques was used for comparison (cephalic, subclavian). In 176 consecutive patients in whom UGVP was used, a total of 68 complex procedures were analyzed (74 ± 8 y, male 73%) with 138 leads implanted including 42 ICD, 48 CRT and 16 upgrade procedures. A majority (83%) was under anti-thrombotic therapy. UGAVP was successful in 96.8%. Mean insertion time for 2.02 guidewires per patient was 4.4 ± 4.4 min. Guidewires insertion time reached its plateau after 10 patients. One pocket hematoma (1.4%) was drained during a mean follow-up of 12 ± 5 months. The control group included 24 patients (8 subclavian, 16 cephalic; 15 ICD, 14 CRT, 4 upgrade procedures), with a mean insertion time of 10 ± 8 min, for 1.95 guidewires per patient ( P < 0.0005). UGVP is feasible and safe even for complex device implantations including CRT/ICD and upgrade procedures.

200 Bleeding Outcomes With Direct-Acting Oral Anticoagulants in Patients Undergoing Cardiac Device Implantation

Over one third of patients undergoing permanent pacemaker or cardiac defibrillator implantation have an indication for therapeutic anticoagulation. Accumulating evidence supports continuation of warfarin therapy for these procedures. The evidence is less clear for direct acting oral anticoagulants (DOAC), medications now more commonly prescribed than warfarin. A best evidence topic was written according to a structured protocol addressing the question “does continuation of direct acting oral anticoagulants affect bleeding outcomes compared to discontinuation among patients undergoing cardiac pacemaker or defibrillator implantation?” Altogether, 1507 papers were found searching Medline, Embase, and Pubmed databases of which five represented the best evidence to answer the clinical question. Although modest evidence exists to answer this question, two recent randomised trials as well as two cohort studies and one case series have addressed the issue with similar findings. Interrupted and uninterrupted DOAC therapy resulted in similar rates of major bleeding (0-2.1% vs 0-4% respectively, no significant p-values reported) particularly in pocket haematoma formation, a clinically important event that substantially increases risk for infection and reoperation. Other adverse events reported were similar between the two groups. In well-selected patients at high risk for thromboembolic complications, it is reasonable to undertake cardiac device implantation without cessation of DOAC therapy as rates of bleeding complications are not significantly higher compared to interrupted therapy.

201 Cardiac Device Related Complications Over 3 Years in a Large Volume Tertiary Centre

Recent, controversial evidence suggests the complication rate in Australia and New Zealand for ICD/ Pacemaker procedures is ∼8.2%. It has been suggested that this figure is skewed by high complication rates in low volume centres. To investigate this, we analysed device related complications over 3 years in a large volume tertiary centre. A total of 1137 devices were implanted over 3 years with 815 new devices (72%), 288 generator changes (25%) and 34 device upgrades (3%). 204 (25%) of the new devices were implantable defibrillators. During the 3 year period, 83 (7.2%) of patients encountered a complication. 25 patients developed a pocket hematoma. Hematoma rates were 5% in patients anticoagulated and 1.25% without anticoagulation. 1 patient developed an infection requiring device extraction. 20 patients required lead revisions for lead dislodgement. 9 patients developed a pneumothorax requiring drainage. 1 patient required pericardiocentesis for RV perforation. There were an additional 10 pneumothoraces and 2 pericardial effusions which were not clinically significant. 15 patients developed other minor complications such as antibiotics allergies. There were no deaths. Even in a high volume centre, device implantation related complications occur at a rate of around 7%. This confirms previous work and should be used to ensure appropriate informed consent is gained from patients.

Adjuvant hepatic arterial infusion pump chemotherapy after resection of colorectal liver metastases; a phase II trial

Introduction: Adjuvant hepatic arterial infusion pump (HAIP) chemotherapy demonstrated promising results with a median overall survival of 67 months (n=785) versus 44 months without HAIP (n=1.583, p<0.001) in a propensity scored analysis in patients with resectable colorectal liver metastases (CRLM).[J Clin Onc;35(17):1938] However, its general application is limited. Previous results from Memorial Sloan Kettering Cancer Center (MSKCC) should be confirmed in a randomized controlled trial (RCT) outside MSKCC. The aim of this study was to investigate the feasibility and safety of HAIP chemotherapy in a multicenter setting in the Netherlands. Materials & Methods: A phase II study was performed in two high-volume centers in the Netherlands. Patients with resectable CRLM without extrahepatic disease were eligible. All patients were scheduled for 6 cycles of adjuvant HAIP chemotherapy with floxuridine, after complete resection of CRLM with pump placement. The main endpoints were feasibility (defined as successful administration of at least one cycle of HAIP chemotherapy) and safety (defined as 90-day postoperative complications). Result(s): Twenty patients with resectable CRLM were included. The median age of patients was 57 years (range 42-75). The median clinical risk score was 2 (range 1-5). All 20 patients (100%) received at least one dose of HAIP chemotherapy at a median of 42.5 days (range 26-57) after surgery. Pump related postoperative complications occurred in 2 patients (10%); replacement of a malfunctioning pump and repositioning of a flipped (upside down) pump. No arterial hemorrhage or dissection, extrahepatic perfusion, catheter related problems, pump pocket hematoma or pump pocket infections were found within 90-days after resection and implantation. Conclusion(s): Adjuvant HAIP chemotherapy in patients with resectable CRLM is safe and feasible as demonstrated in a phase II study of 20 patients. The PUMP trial (NTR 7493) has started to investigate the effectiveness of adjuvant HAIP chemotherapy in a randomized controlled trial.

Adjuvant Hepatic Arterial Infusion Pump Chemotherapy After Resection of Colorectal Liver Metastases: Results of a Safety and Feasibility Study in The Netherlands

BackgroundThe 10-year overall survival with adjuvant hepatic arterial infusion pump (HAIP) chemotherapy after resection of colorectal liver metastases (CRLMs) was 61% in clinical trials from Memorial Sloan Kettering Cancer Center. A pilot study was performed to evaluate the safety and feasibility of adjuvant HAIP chemotherapy in patients with resectable CRLMs.Study DesignA phase II study was performed in two centers in The Netherlands. Patients with resectable CRLM without extrahepatic disease were eligible. All patients underwent complete resection and/or ablation of CRLMs and pump implantation. Safety was determined by the 90-day HAIP-related postoperative complications from the day of pump placement (Clavien–Dindo classification, grade III or higher) and feasibility by the successful administration of the first cycle of HAIP chemotherapy.ResultsA total of 20 patients, with a median age of 57 years (interquartile range [IQR] 51–64) were included. Grade III or higher HAIP-related postoperative complications were found in two patients (10%), both of whom had a reoperation (without laparotomy) to replace a pump with a slow flow rate or to reposition a flipped pump. No arterial bleeding, arterial dissection, arterial thrombosis, extrahepatic perfusion, pump pocket hematoma, or pump pocket infections were found within 90 days after surgery. After a median of 43 days (IQR 29–52) following surgery, all patients received the first dose of HAIP chemotherapy, which was completed uneventfully in all patients.ConclusionPump implantation is safe, and administration of HAIP chemotherapy is feasible, in patients with resectable CRLMs, after training of a dedicated multidisciplinary team.

The relationship between pocket hematoma and risk of wound infection among patients with a cardiovascular implantable electronic device: An integrative review

BackgroundPocket hematoma is a common adverse event following the insertion of cardiovascular implantable electronic devices (CIEDs), but the risk of wound infections associated with a pocket hematoma is unclear. ObjectivesThis integrative review aims to examine the relationship between pocket hematoma and risk of wound infection in a CIED population. MethodsA comprehensive literature search for articles assessing the relationship between pocket hematoma and infection in four electronic databases was conducted in October 2018. ResultsAfter screening and full text review, 7 studies met inclusion criteria (combined sample = 8,177 patients). Most studies (6/7) reported a significant relationship between pocket hematoma and all types of infection (OR = 6.9–24.98; p < 0.05). The proportion of wound infection among all types of infections was 61.5 - 100%. ConclusionsPocket hematoma is a significant risk factor for all types of infection, with the most frequent type of infection being wound infection.

P3141Transvenous lead extractions in patients on continuous flow left ventricular assist device support

Abstract Objectives The outcomes of transvenous lead extractions in patients with left ventricular assist device support and a cardiac implantable electronic device (CIED) are not well studied. The purpose of this study was to examine the feasibility and safety of transvenous lead extraction in this patient cohort. Methods We performed a retrospective single-center analysis of patients with a left ventricular assist device and a CIED undergoing a transvenous lead extraction procedure. Between October 2014 and November 2018 we overall performed transvenous lead extractions (TLE) of 622 leads in 286 patients. During this time period we performed transvenous lead extractions In 34 patients (mean age 60.9±9.4 years; 32 male, 2 female) with different continuous flow left ventricular assist devices (LVAD). A total of 91 leads were targeted for extraction in these LVAD patients. Indication for extraction was infection in 79.4% (n=27; systemic infection=15 (44.1%), local pocket infection n=12 (35.3%)) and lead failure in 20.6% (n=7). Mean lead implant duration was 80.7 (1–252) months. 55 pacemaker leads and 36 ICD leads (30 dual coil, 6 single coil) were extracted. Results Complete procedural success could be achieved in 86 of 91 leads (94.5%). In 79.1% (n=72) a locking stylet and a compression coil, in 73.6% (n=67) a bidirectional rotational extraction sheath was used. No operative mortality and no major complications were observed. 30-day mortality was 5.9% (n=2). Minor complications occurred in 7 patients (20.6%), mainly consisting of bleeding complications: pocket hematoma (n=5; 14.7%) and hematothorax (n=1; 2.9%). Conclusions Patients on continuous flow left ventricular assist device support represent a challenging population in many regards, especially considering the altered coagulation system and device associated infection management. TLE procedures in LVAD patients are feasible and safe, however associated with an increased risk for postoperative bleeding complications.

P6019His-Purkinje system pacing in single centre experience after 324 cases

Abstract Introduction His-Purkinje system pacing preserves or restores physiologic depolarization of the left ventricle during permanent pacing. It consists of two complementary techniques: His bundle pacing (HB-P) and the recently introduced left bundle branch pacing (LBB-P). There is limited data on HB-P outcomes and only a few reports of LBB-P results. Purpose Our aim was to investigate success rate, complications, acute and early pacing parameters in patients undergoing HB-P and LBB-P in the setting of a cardiology tertiary centre that routinely implants HB-P and LBB-P pacemakers. Methods On the basis of a prospective database we performed a longitudinal cohort study of all consecutive patients with His-Purkinje system devices implanted in the years 2014–2019. In all cases, model 3830 lumen-less 4.1 Fr pacing lead was used. HB-P was achieved via HB mapping or pace mapping, LBB-P was achieved via deep septal lead deployment under electrophysiological and 12-lead ECG guidance. Results Since 2014 there were 324 implantations of His-Purkinje system pacemakers. Baseline patients' characteristics are presented in Table. The overall success rate was 81.5%. Selective HB-P, non-selective HB-P and LBB-P were achieved in 53%, 19% and 28% of successful cases. The mean fluoroscopy time was 11±9 min. The lead delivery was performed using single sheath (C315His) in 83% cases, while in 17% extra steerable sheath was necessary (C304XL). The acute mean LBB-P capture threshold @0.5 ms was significantly lower than in HB-P (0.65±0.43V vs. 1.47±0.8V). The mean chronic LBB-P capture threshold @1.0 ms was also lower than in HB-P (0.45±0.3V vs. 0.95±0.7V, p&lt;0.001). The acute sensing amplitude was significantly higher in LBB-P vs HB-P (10±5mV vs 4±3mV). The mean paced QRS duration was significantly shorter for selective HB-P (113±22 ms) and LBB-P (108±12 ms) vs. non-selective HB-P (132±22 ms). The complications included: 4 cases of threshold increase that required lead revision; 3 early lead dislodgments; 1 loss of LBB capture, 3 pocket hematomas, 2 system infections and 1 pneumothorax. Baseline characteristics Age; sex 73±12 years (19–95 years); 64% males Mean EF; mean QRS duration; Presence of heart failuire or ischemic heart disease 47±15%; 128±32 ms; 48%; 37.5% Pacing indication AV block 31%; sinus node disease 12%; atrial fibrillation with bradycardia 37%; CRT 20% QRS morphology narrow QRS 61%; LBBB 20%; other 14%; IVCD 6% CRT, Cardiac Resynchronization Therapy; IVCD, Interventricular Conduction Delay. Conclusion His-Purkinje system pacing in routine practice has an acceptable success rate, pacing parameters and complication rate; the LBB-P provides better pacing parameters than HB-P. We believe that such single-centre experience paves the way for a large randomized trial of physiologic pacing.

P2884Complications of cardiac implantable electronic device intervention in patients with left ventricular assist devices

Abstract Background There are limited data on management of cardiac implantable electronic devices (CIED) in patients with left ventricular assist devices (LVADs). These patients may be at elevated risk of complications after undergoing CIED procedures. Purpose In order to better understand these risks, we set out to describe and quantify the complications associated with CIED procedures among patients with LVADs. Methods We retrospectively evaluated all patients with LVADs at our institution (n=235) from August 2007 to November 2017 who had any subsequent CIED procedure (initial implant, generator exchange, lead revision or extraction). We identified device-related complications at 30 days and one year from the time of the CIED procedure. Complications were defined as death, stroke, cardiac perforation, pericardial effusion, pneumothorax, lead dislodgment, infection, and any hematoma requiring a direct physician encounter. Results Forty-eight CIED interventions were performed on 42 patients after LVAD implant. Mean age was 49.4±15.1 years and 64% were male. Mean duration of LVAD therapy prior to procedure was 396 days. All patients were on warfarin therapy (mean INR 2.33±0.68); in 83% of procedures patients were on at least one anti-platelet agent. All interventions involved placement or revision of an ICD system. Fourteen procedures (29%) were initial implants and 34 (71%) were secondary procedures (19 generator exchanges, 13 lead revisions ± generator exchange and 2 extractions). Seven procedures (14.5%) were complicated by pocket hematoma; all of these were in secondary procedures. Patients with hematomas trended toward higher INR (2.51±0.26 vs 2.31±0.72); this was not statistically significant. Two patients with hematoma developed CIED infection, resulting in a total infection rate of 4.2%. Of those, one developed systemic infection requiring extraction of the system and the other developed a pocket infection managed with pocket washout and prolonged antibiotics. All complications occurred within 30 days of the procedure (Figure 1). Figure 1. Complication free survival Conclusion In this single center study, CIED procedures on patients with preexisting LVAD was associated with a low rate of complications requiring intervention. Acknowledgement/Funding Emory University

Effect of Direct Oral Anticoagulants, Warfarin, and Antiplatelet Agents on Risk of Device Pocket Hematoma: Combined Analysis of BRUISE CONTROL 1 and 2.

Oral anticoagulant use is common among patients undergoing pacemaker or defibrillator surgery. BRUISE CONTROL (Bridge or Continue Coumadin for Device Surgery Randomized Controlled Trial; NCT00800137) demonstrated that perioperative warfarin continuation reduced clinically significant hematomas (CSH) by 80% compared with heparin bridging (3.5% versus 16%). BRUISE-CONTROL-2 (NCT01675076) observed a similarly low risk of CSH when comparing continued versus interrupted direct oral anticoagulant (2.1% in both groups). Using patient level data from both trials, the current study aims to: (1) evaluate the effect of concomitant antiplatelet therapy on CSH, and (2) understand the relative risk of CSH in patients treated with direct oral anticoagulant versus continued warfarin. We analyzed 1343 patients included in BRUISE-CONTROL-1 and BRUISE-CONTROL-2. The primary outcome for both trials was CSH. There were 408 patients identified as having continued either a single or dual antiplatelet agent at the time of device surgery. Antiplatelet use (versus nonuse) was associated with CSH in 9.8% versus 4.3% of patients (P<0.001), and remained a strong independent predictor after multivariable adjustment (odds ratio, 1.965; 95% CI, 1.202-3.213; P=0.0071). In multivariable analysis, adjusting for antiplatelet use, there was no significant difference in CSH observed between direct oral anticoagulant use compared with continued warfarin (odds ratio, 0.858; 95% CI, 0.375-1.963; P=0.717). Concomitant antiplatelet therapy doubled the risk of CSH during device surgery. No difference in CSH was found between direct oral anticoagulant versus continued warfarin. In anticoagulated patients undergoing elective or semi-urgent device surgery, the patient specific benefit/risk of holding an antiplatelet should be carefully considered. URL: https://www.clinicaltrials.gov. Unique identifiers: NCT00800137, NCT01675076.