Efficacy and safety of regenerated cellulose topical gauze haemostats in managing secondary haemostasis: a randomised control trial.

OBJECTIVE: To compare the efficacy and safety of HemoStyp (United Health Products, US), a neutralised oxidised regenerated cellulose (NORC) and Surgicel (Johnson & Johnson, US), an oxidised regenerated cellulose (ORC), in the management of bleeding of surgical wounds during abdominal, thoracic and vascular surgeries. METHOD: This study was a prospective, non-inferiority, multicentre, randomised, open-label trial. Surgical procedures were performed according to expected standard of care and in compliance with all relevant laws and institutional guidelines. Patients who developed Lewis Bleeding Scale grade 1 and grade 2 bleeds not controlled through conventional techniques were randomised to either the NORC or ORC treatment arms. Bleeding was measured every 30 seconds after treatment, ending at five minutes after haemostasis was achieved or at 10 minutes if haemostasis was not achieved. RESULTS: A total of 236 patients were included in the study. There was a total of seven adverse events in the study, none of which had causality related to either the NORC or ORC. For all surgical procedures, haemostasis was achieved more quickly with the NORC than the ORC (p CONCLUSION: For patients in this study, haemostasis was achieved more quickly in the NORC treatment group compared with the ORC group, in patients with Lewis grade 1 or 2 bleeds caused by surgical wounds generated during abdominal, thoracic and vascular surgeries

Defibrillation thresholds with right pectoral implantable cardioverter defibrillators and impact of waveform tuning (the Tilt and Tune trial).

Aims: Assess defibrillation thresholds (DFTs) with right active pectoral implantable cardioverter defibrillator (RICDs). Defibrillation thresholds in patients receiving RICDs are regarded as \u27high\u27 and potentially improved by waveform optimization (tuning). However, this has not been systematically tested. Methods and results: Patients receiving RICDs [Single chamber (VVI) = 16, DDD = 32, cardiac resynchronization therapy (CRT) = 43] were randomized to either 50/50% fixed tilt (FT) or tuned waveform (3.5 ms time constant based). Defibrillation threshold was tested with a binary search protocol in single coil anodal configuration. Then RICDs were compared with left-sided placements. Baseline patient characteristics in FT (n = 54) and tuned (n = 37) were similar (65 ± 14 years, 71% male, Left ventricular ejection fraction 31 ± 13%; and proportions VVI/DDD/Cardiac resynchronization therapy defibrillator). Tuning reduced Phase 1 by 15% and Phase 2 by 45%. For FT vs. tuned: high voltage impedance was 61.9 ± 13.2 vs. 64.5 ± 12.7 Ω (P = 0.33) and mean DFT 14.2 ± 8.8 vs. 14.9 ± 9.2 J (P = 0.8). When high voltage impedance was \u3e62 Ω (mean 73.6 ± 8.6 Ω), DFT was identical [FT 13.0 ± 7.9 J vs. tuned 12.0 ± 5.9 J (P= 0.7)]. Defibrillation thresholds exceeded 20 J (600 V) in \u3e20% of patients [FT 11/54 (20.4%) vs. tuned 12/37 (32%) patients]. Defibrillation threshold with RICD was greater and exhibited wider dispersion compared with left ICDs (n = 54) under similar conditions. Conclusion: This first randomized trial investigating DFTs with right ICDs confirms relatively higher DFTs with RICDs than reported for left pectoral ICDs. However, DFTs were generally unaffected by 3.5 ms time constant-based waveform tuning compared with a 50% tilt waveform. Implant testing may be preferred with RICDs. Clinical trial number: NCT00873691

Transcatheter aspiration of large pacemaker and implantable cardioverter-defibrillator lead vegetations facilitating safe transvenous lead extraction

AIMS Treatment of patients with systemic cardiac implantable electronic device (CIED) infection with large lead vegetations is challenging and associated with relevant morbidity and mortality. To avoid complications from open surgical extraction, a novel approach with percutaneous aspiration of large vegetations prior to transvenous lead extraction was instituted. The results of this treatment concept were retrospectively analysed in this multicentre study. METHODS AND RESULTS One hundred and one patients [mean age 68.2 ± 13.1 (30-92) years] were treated in four centres for endovascular CIED infection with large lead vegetations. Mean lead vegetation size was 30.7 ± 13.5 mm. Two hundred and forty-seven leads were targeted for extraction (170 pacemaker leads, 77 implantable cardioverter-defibrillator leads). Mean lead implant duration was 81.7 (1-254) months. The transcatheter aspiration system with a specialized long venous drainage cannula and a funnel-shaped tip was based on a veno-venous extracorporeal circuit with an in-line filter. The aspiration of vegetations showed complete procedural success in 94.0% (n = 95), partial success in 5.0% (n = 5). Three major complications (3.0%) were encountered. Complete procedural success (per lead) of the subsequently performed transvenous lead extraction procedure was 99.2% (n = 245). Thirty-day mortality was 3.0% (n = 3). Five patients (5.0%) died in the further course on Days 51, 54, 68, 134, and 182 post-procedure (septic complications: n = 4; heart failure: n = 1). CONCLUSION The percutaneous aspiration procedure is highly effective and is associated with a low complication profile. The aspiration of vegetations immediately prior and during the lead extraction procedure may avoid septic embolization into the pulmonary circulation. This may potentially lead to a long-term survival benefit

Transcatheter aspiration of large pacemaker and implantable cardioverter-defibrillator lead vegetations facilitating safe transvenous lead extraction.

AIMS: Treatment of patients with systemic cardiac implantable electronic device (CIED) infection with large lead vegetations is challenging and associated with relevant morbidity and mortality. To avoid complications from open surgical extraction, a novel approach with percutaneous aspiration of large vegetations prior to transvenous lead extraction was instituted. The results of this treatment concept were retrospectively analysed in this multicentre study. METHODS AND RESULTS: One hundred and one patients [mean age 68.2 ± 13.1 (30-92) years] were treated in four centres for endovascular CIED infection with large lead vegetations. Mean lead vegetation size was 30.7 ± 13.5 mm. Two hundred and forty-seven leads were targeted for extraction (170 pacemaker leads, 77 implantable cardioverter-defibrillator leads). Mean lead implant duration was 81.7 (1-254) months. The transcatheter aspiration system with a specialized long venous drainage cannula and a funnel-shaped tip was based on a veno-venous extracorporeal circuit with an in-line filter. The aspiration of vegetations showed complete procedural success in 94.0% (n = 95), partial success in 5.0% (n = 5). Three major complications (3.0%) were encountered. Complete procedural success (per lead) of the subsequently performed transvenous lead extraction procedure was 99.2% (n = 245). Thirty-day mortality was 3.0% (n = 3). Five patients (5.0%) died in the further course on Days 51, 54, 68, 134, and 182 post-procedure (septic complications: n = 4; heart failure: n = 1). CONCLUSION: The percutaneous aspiration procedure is highly effective and is associated with a low complication profile. The aspiration of vegetations immediately prior and during the lead extraction procedure may avoid septic embolization into the pulmonary circulation. This may potentially lead to a long-term survival benefit

Regional Thoracic Surgery Quality Collaboration Formation: Providence Thoracic Surgery Initiative.

BACKGROUND: Surgery quality initiatives improve clinical outcomes in cardiac and general surgery. No mature thoracic surgery (TS) regional effort has been described. METHODS: An intramural grant funded the Thoracic Surgery Initiative (TSI). Using professional organization, site specific administrative and clinical databases, surgeons performing TS across a large western health system were identified. Participants were recruited through stakeholder surveys, personal contact and meetings. Differences in practices and outcomes were identified. 14 centers performing TS in 5 states formed the TSI with a mission to define, implement and monitor TS quality. RESULTS: A TS data system based on Society of Thoracic Surgeons General TS Database was implemented. 2015/2016 clinical data revealed significant differences in outcomes. Clinical data allows quality implementation including identification and propagation of internal best practices and monitoring. TS practice standardization was agreed to using predefined TS best practice components that were incorporated into standardized TS care documents. Standardized care document completion by providers was intended to provoke desired TS care. The standardized care documents reside on the system wide electronic health record. Using literature and substantial surgeon experience, standardized TS care pathways for important or common clinical scenarios were developed (pneumonectomy, primary spontaneous pneumothorax, etc). The TSI internet site serves as a harbor for standardization products. CONCLUSIONS: The TSI is evolving. Surgeon engagement remains high. The TSI enabled surgeons to lead, set the agenda and remain in control of our destiny. Indeed, health care cannot appropriately evolve without such physician vision, engagement and leadership