Pressure-dimension index and left ventricular sphericity index following HeartMate II and HeartMate 3 implantation.

AIMS: This study aimed to compare the changes in the left ventricle (LV) and right ventricle (RV) geometry and performance after the implantation of HeartMate II (HMII) and HeartMate 3 (HM3). In addition, we investigated whether the echocardiographic parameters LV sphericity index (LVSI) and the novel pressure-dimension index (PDI) can predict post-operative right ventricular failure (RVF). METHODS AND RESULTS: Between 2012 and 2020, 46 patients [HMII (n = 22) and HM3 (n = 24)] met the study's criteria and had echocardiography tests pre-operatively, 6 and 12 months post-operatively. The LVSI and PDI were calculated together with the standard LV and RV echocardiographic parameters. The mean follow-up was 24 ± 7 months. In both groups, the LV end-diastolic diameter (LVEDD) significantly decreased 12 months post-operatively compared with the pre-operative values (HMII: 6.4 ± 1.4 cm vs. 5.7 ± 0.9 cm, P = 0.040; HM3: 6.7 ± 1.3 cm vs. 5.5 ± 0.9 cm, P < 0.01, respectively). RV function 12 months post-operatively was better in the HM3 group than in the HMII group, as indicated by a significantly higher RV fractional area change (RVFAC) in the HM3 group than in the HMII group 12 months post-operatively (35 ± 12% vs. 26 ± 16%, P = 0.039), significantly higher tricuspid annular plane systolic excursion (TAPSE) in the HM3 group 12 months post-operatively compared with the HMII group (13.9 ± 1.9 mm vs. 12.0 ± 2.1 mm, P = 0.002), and the tissue Doppler estimated tricuspid annular systolic velocity (TASV) was also significantly higher in the HM3 group 12 months post-operatively compared with the HMII group (11.5 ± 2.7 mm/s vs. 9.9 ± 1.5 mm/s, P = 0.020). The LVSI value was significantly higher 12 months post-operatively in the HMII group than in the HM3 group (1.2 ± 0.4 vs. 0.8 ± 0.2, P = 0.001, respectively), indicating worse geometric changes. The PDI decreased 12 months post-operatively in the HM3-group compared with the baseline (3.4 ± 1.4 mmHg/cm2 vs. 2.0 ± 0.8 mmHg/cm2, P < 0.001). In the univariate and multivariate analyses, only the pre-operative PDI was a predictor of post-operative RVF [odds ratio: 3.84 (95% CI: 1.53-18.16, P = 0.022)]. The area under the curve for pre-operative PDI was 0.912. The 2 year survival was significantly better in the HM3 group (log-rank, P = 0.042). CONCLUSIONS: The design of HM3 offered better geometrical preservation of the LV and enabled normal PDI values, leading to improved RV function, as indicated by better RVFAC, TAPSE, and TASV values. The use of pre-operative PDI as an additional tool for established risk scores might offer a better pre-operative predictor of RVF.

Conventional vs. Sutureless Aortic Valve Bioprosthesis: Is Faster Better?

Purpose: The benefits of sutureless compared to conventional aortic valve prosthesis replacement remain controversial. Supposed advantages of sutureless aortic valve replacement include shortened cross-clamp and implantation time, as well as improved overall safety and good post-operative performance. We aimed to compare the early outcomes and performance of sutureless aortic valve replacement (su-AVR) with the sutureless Perceval (Corcym, Milan, Italy) vs. the conventional AVR with a conventional counterpart, in this case, the Labcor Dokimos Plus (LDP) aortic bioprosthesis. Methods: We compared two types of aortic valve prostheses, the sutureless (Corcym, Milan, Italy) and the conventional valve Labcor Dokimos Plus (LDP), implanted between August 2014 and May 2019 in our Department of Cardiac Surgery at RWTH Aachen University Hospital. Data were collected from 141 patients who received the Perceval (Corcym, Milan, Italy) and 138 who received the Labcor Dokimos Plus (LDP) aortic bioprosthesis. After matching the two groups considering STS mortality risk and pre-operative LDH levels, 201 patients were included in our final study cohort. Seventy-one patients (17 from the Perceval group and 54 from the Dokimos group) were excluded due to the lack of complete data, particularly standardized echocardiographic data (n = 71). Primary endpoints were 30-day mortality, length of hospital stay, and pacemaker implantation. Secondary endpoints were echocardiographic parameters, major adverse cardiovascular events, and prosthesis failure (grade II aortic regurgitation, paravalvular leak with reintervention). Results: Bypass and cross-clamp time proved to be shorter in the Perceval group, while hospital stays were longer. The faster implantation had no effect on the 30-day mortality primary endpoint. Transvalvular gradients were significantly higher in the Perceval group, in addition to a smaller effective orifice area. The LDH values were remarkably higher post-operatively in the Perceval group. Conclusions: Regarding the clinical outcomes, Perceval was equivalent and not superior to the Dokimus bioprosthesis. The suitability of a Perceval prosthesis implantation must be determined on a case-by-case basis and reserved for elderly patients with increased comorbidity.

Conventional Prostheses versus Sutureless Perceval for Aortic Valve Replacement: A Meta-Analysis.

PURPOSE: Perceval sutureless valves have gained popularity. Whether this implant performs superior to the traditional sutured prosthesis remains unclear. This meta- analysis compared the Perceval implants versus the sutured conventional valves for aortic valve replacement (AVR). METHODS: This meta-analysis was conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. The following databases were accessed: PubMed, Google Scholar, Web of Science, Scopus, and EMBASE. All clinical investigations comparing Perceval versus the conventional prostheses for AVR were considered. RESULTS: The Perceval group demonstrated higher rate of pacemaker implantation (P <0.00001). Aortic cross-clamp (ACC) time (P <0.00001) and cardiopulmonary bypass (CPB) time (P <0.00001) were shorter in the Perceval group. Similarity was found in mean and peak pressure gradient (P = 0.8 and P = 0.2, respectively), mean aortic valve area (P = 0.3), length of intensive care unit (P = 0.4) and hospital stay (P = 0.2), rate of revision (P = 0.11), hemorrhages (P = 0.05), paravalvular leak (P = 0.3), cerebrovascular complication (P = 0.7), and early mortality (P = 0.06). CONCLUSION: Given the shorter ACC time and CPB time, Perceval AVR can be an alternative in high-risk patients. The higher rate of pacemaker implantation following Perceval may limit its routine implantation.

VAD Patients' Perception of Potential Telemedicine Support.

Technical possibilities for patient support must be user-friendly. This includes acceptance on the part of the patients, and safe function that must not lead to the user being overtaxed. In a study of Ventricular Assist Device (VAD) patients at the Department of Thoracic and Cardiovascular Surgery at the University Hospital RWTH Aachen, a questionnaire was used to investigate the current situation in dealing with the VAD system. This was followed by a query about ideas, wishes, and fears regarding the increased use of telemedical applications. An adapted Service User Technology Acceptability Questionnaire (SUTAQ) was used and the evaluation was carried out with the help of Office-based applications. As a result, it can be stated that the patients do not want to see personal contacts and care be completely replaced by telemedical remote support. If the application is stable and functioning, the majority is very much open to such support.

Combining Minimally Invasive Surgery With Ultra-Fast-Track Anesthesia in HeartMate 3 Patients: A Pilot Study.

BACKGROUND: Minimally invasive surgery for left ventricular assist device implantation may have advantages over conventional sternotomy (CS). Additionally, ultra-fast-track anesthesia has been linked to better outcomes after cardiac surgery. This study summarizes our early experience of combining minimally invasive surgery with ultra-fast-track anesthesia (MIFTA) in patients receiving HeartMate 3 devices and compares the outcomes between MIFTA and CS. METHODS: From October 2015 to January 2019, 18 of 49 patients with Interagency Registry for Mechanically Assisted Circulatory Support profiles >1 underwent MIFTA for HeartMate 3 implantation. For bias reduction, propensity scores were calculated and used as a covariate in a regression model to analyze outcomes. Weighted parametric survival analysis was performed. RESULTS: In the MIFTA group, intensive care unit stays were shorter (mean difference, 8 days [95% CI, 4-13]; P<0.001), and the incidences of pneumonia and right heart failure were lower than those in the CS group (odds ratio, 1.36 [95% CI, 1.01-1.75]; P=0.016, respectively). At 6 and 12 hours postoperatively, MIFTA patients had a better hemodynamic performance with lower pulmonary wedge pressure (mean difference, 2.23 mm Hg [95% CI, 0.41-4.06]; P=0.028) and a higher right ventricular stroke work index (mean difference, -1.49 g·m/m2 per beat [95% CI, -2.95 to -0.02]; P=0.031). CS patients had a worse right heart failure-free survival rate (hazard ratio, 2.35 [95% CI, 0.96-5.72]; P<0.01). CONCLUSIONS: Compared with CS, MIFTA is a beneficial approach for non-Interagency Registry for Mechanically Assisted Circulatory Support 1 HeartMate 3 patients with lower adverse event incidences, better hemodynamic performance, and preserved right heart function. Future large multicentric investigations are required to verify MIFTA's effects on outcomes.

High-dose supplementation of selenium in left ventricular assist device implant surgery: A double-blinded, randomized controlled pilot trial.

BACKGROUND: Systemic inflammation and oxidative stress remain the main causes of complications in patients with heart failure receiving a left ventricular assist device (LVAD). Selenoproteins are a cornerstone of antioxidant defense mechanisms for improving inflammatory conditions. METHODS: In a monocentric, double-blinded pilot trial patients scheduled for LVAD implantation were randomized to receive 300 mcg of selenium orally the evening before surgery, followed by a high-dose of intravenous selenium supplementation (3000 mcg after anesthesia induction, 1000 mcg upon intensive care unit [ICU] admission, and 1000 mcg daily in the ICU for a maximum of 14 days) or placebo. The main outcomes were feasibility and effectiveness in restoring serum selenium concentrations. RESULTS: Twenty patients were included in the analysis. The average duration of study intervention was 12.6 days (7-14), with 97.7% dose compliance. No patient received open-label selenium. The supplementation strategy was effective in compensating low serum selenium concentrations (before surgery: control, 63.5 ± 11.9 mcg/L vs intervention, 65.8 ± 16.5 mcg/L; ICU admission: control, 49.0 ± 9.8 mcg/L vs intervention, 144.2 ± 45.4 mcg/L). Serum selenium concentrations in the intervention group were significantly higher during the observation period (baseline: mean of placebo (MoP), 63.1 vs mean of selenium (MoS), 64.0; ICU admission: MoP, 49.0 vs MoS, 144.6; day 1-13: MoP, 43.6-48.5 vs MoS, 100.4-131.0). CONCLUSION: Selenium supplementation in patients receiving LVAD implantation is feasible and effective to compensate a selenium deficiency.

Study design and rationale of the pAtients pResenTing with cOngenital heaRt dIseAse Register (ARTORIA-R).

AIM: Due to improved therapy in childhood, many patients with congenital heart disease reach adulthood and are termed adults with congenital heart disease (ACHD). ACHD often develop heart failure (HF) as a consequence of initial palliative surgery or complex anatomy and subsequently require advanced HF therapy. ACHD are usually excluded from trials evaluating heart failure therapies, and in this context, more data about heart failure trajectories in ACHD are needed to guide the management of ACHD suffering from HF. METHODS AND RESULTS: The pAtients pResenTing with cOngenital heaRt dIseAse Register (ARTORIA-R) will collect data from ACHD evaluated or listed for heart or heart-combined organ transplantation from 16 countries in Europe and the Asia/Pacific region. We plan retrospective collection of data from 1989-2020 and will include patients prospectively. Additional organizations and hospitals in charge of transplantation of ACHD will be asked in the future to contribute data to the register. The primary outcome is the combined endpoint of delisting due to clinical worsening or death on the waiting list. The secondary outcome is delisting due to clinical improvement while on the waiting list. All-cause mortality following transplantation will also be assessed. The data will be entered into an electronic database with access to the investigators participating in the register. All variables of the register reflect key components important for listing of the patients or assessing current HF treatment. CONCLUSION: The ARTORIA-R will provide robust information on current management and outcomes of adults with congenital heart disease suffering from advanced heart failure.

Prevention of Sternal Wound Infections in Women Using an External Sternum Fixation Corset.

PURPOSE: Deep sternal wound infection (DSWI) and mediastinitis are devastating complications after median sternotomy. Previous studies demonstrated an effective prevention of sternal wound infection (SWI) using an external sternal corset in high-risk cardiac surgery patients. The aim of this study is to assess the preventive effect of the Stern-E-Fix corset in high-risk poststernotomy female patients. METHODS: A total of 145 high-risk female patients undergoing cardiac surgery through median sternotomy were retrospectively analyzed. Patients were divided into group A (n = 71), who received the Stern-E-Fix corset (Fendel & Keuchen GmbH, Aachen, Germany), and group B (n = 74), who received the elastic thorax bandage (SanThorax) postoperatively for 6 weeks. The mean follow-up period was 12 weeks. RESULTS: Incidence of SWI was 7% in group A vs. 17.6% in group B (p = 0.025). One patient presented with DSWI in group A vs. seven patients in group B (p = 0.063). No patient developed mediastinitis in group A vs. four patients in group B (p = 0.121). In all, 4.2% of group A patients required operative wound therapy vs. 16.2% of group B patients (p = 0.026). The length of hospital stay was significantly longer in group B (p = 0.006). CONCLUSION: Using an external supportive sternal corset (Stern-E-Fix) yields a significantly better and effective prevention against development of sternal dehiscence, DSWI, and mediastinitis in high-risk poststernotomy female patients.

Clinical characteristics and outcomes of patients with adult congenital heart disease listed for heart and heart‒lung transplantation in the Eurotransplant region.

BACKGROUND: The therapeutic success in patients with congenital heart disease (CHD) leads to a growing number of adults with CHD (adult CHD [ACHD]) who develop end-stage heart failure. We aimed to determine patient characteristics and outcomes of ACHD listed for heart transplantation. METHODS: Using data from all the patients with ACHD in 20 transplant centers in the Eurotransplant region from 1999 to 2015, we analyzed patient characteristics, waiting list, and post-transplantation outcomes. RESULTS: A total of 204 patients with ACHD were listed during the study period. The median age was 38 years, and 62.3% of the patients were listed in high urgency (HU), and 37.7% of the patients were in transplantable (T)-listing status. A total of 23.5% of the patients died or were delisted owing to clinical worsening, and 75% of the patients underwent transplantation. Median waiting time for patients with HU-listing status was 4.18 months and with T-listing status 9.07 months. There was no difference in crude mortality or delisting between patients who were HU status listed and T status listed (p = 0.65). In multivariable regression analysis, markers for respiratory failure (mechanical ventilation, hazard ratio [HR]: 1.41, 95% CI: 1.11-1.81, p = 0.006) and arrhythmias (anti-arrhythmic medication, HR: 1.42, 95% CI: 1.01-2.01, p = 0.044) were associated with a higher risk of death or delisting. In the overall cohort, post-transplantation mortality was 26.8% after 1 year and 33.4% after 5 years. CONCLUSIONS: Listed patients are at high risk of death without differences in the urgency of listing. Respiratory failure requiring invasive ventilation and possibly arrhythmias requiring anti-arrhythmic medication indicate worse outcomes on waiting list.

Rescue operation retrieving an incorrectly implanted cardiac event recorder from the left main pulmonary artery.

Continuous heart rhythm monitoring with cardiac event recorders is increasing in clinical practice and may be helpful in diagnosing a wide range of disorders and pathologies. This case study describes the case of an 80-year-old female patient with a medical history of previous cardiac surgery in which a cardiac event recorder had to be retrieved from the left main pulmonary artery.

Effective Combination of Different Surgical Strategies for Deep Sternal Wound Infection and Mediastinitis.

PURPOSE: Timing and ideal reconstructive approach in deep sternal wound infection (DSWI) and mediastinitis still remain controversially debated. We present our own combined surgical strategy of bilateral pectoralis major muscle flap (BPMMF) or omental flap (OF) transposition. METHODS: Between July 2010 and July 2016, poststernotomy patients with DSWI and mediastinitis underwent a secondary wound closure with modified BPMMF (Group A, center for disease control class (CDC)-II, n = 21; Group B, CDC-III, n = 20) or with OF (Group C, CDC-III, n = 19) following vacuum-assisted closure (VAC). RESULTS: Significant risk factors for mediastinitis (CDC-III) were chronic obstructive pulmonary disease (COPD; p = 0.001), peripheral arterial disease (PAD; p = 0.012), cardiopulmonary bypass (CPB) time (p = 0.027), total operation time (p = 0.039), total intensive care unit (ICU) stay (p = 0.011), and blood transfusion (p = 0.049). Mean antibiotic therapy (18.4 ± 8.8[B] vs. 36.2 ± 24.4[C] days, p = 0.026) and length of hospitalization (25.2 ± 12.1[B] vs 53.8 ± 18.5 days[C], p = 0.053) were significantly longer in group C. In-hospital death was 3/19 (15.8%) in group C versus 0 in group B (p = 0.026). Frequency of recurrent mediastinitis was equal (p = 0.92); however, complications occurred more often in group C (31.6% vs. 0%, p = 0.031). The mean follow-up time was 111 ± 62 days. CONCLUSION: In younger (<70 years) patients without sternal bone necrosis, the BPMMF is superior to the OF technique with relatively low recurrence and mortality risks.

Radial Artery Tonometry to Monitor Blood Pressure and Hemodynamics in Ambulatory Left Ventricular Assist Device Patients in Comparison With Doppler Ultrasound and Transthoracic Echocardiography: A Pilot Study.

Noninvasive measurements of blood pressure (BP) and cardiac output (CO) are crucial in the follow-up of continuous-flow left ventricular assist device (CF-LVAD) patients. For our pilot study, we sought to compare BP measurements between a tonometry blood pressure pulse analyzer (BPPA) (DMP-Life, DAEYOMEDI Co., Ltd., Gyeonggi-do, South Korea) and Doppler ultrasound in CF-LVAD patients, as well as to compare the BPPA estimated CO to LVAD calculated blood flow and to the patient's intrinsic CO estimated with transthoracic echocardiography (TTE). Ambulatory CF-LVAD patients (6 HeartMate, 26 HeartMate II), were included. According to TTE findings, patients were then subdivided in two groups: patients with an opening aortic valve (OAV) [n = 21] and those with an intermittent opening aortic valve (IOAV) [n = 11]. We found a very good correlation of systolic BP (SBP) measurements between the two methods, BPPA and Doppler ultrasound (r = 0.87, P < 0.0001). Bland-Altman plots for SBP revealed a low bias of -4.6 mm Hg and SD of ±4.7 mm Hg. In CF-LVAD patients with IOAV, the BPPA-CO had a good correlation with the LVAD-flow (r = 0.78, P < 0.0001), but in OAV patients, there was no correlation. After adding the patient's intrinsic CO, estimated from TTE in patients with OAV to the LVAD-flow, we found a very good correlation between the BPPA-CO and LVAD-flow + TTE-CO (r = 0.81, P = 0.002). Our study demonstrated that compared with the standard clinical method, Doppler ultrasound, the BPPA measured BP noninvasively with good accuracy and precision of agreement. In addition, tonometry BPPA provided further valuable information regarding the CF-LVAD patient's intrinsic CO.

In vitro comparison of the hemocompatibility of two centrifugal left ventricular assist devices.

OBJECTIVES: Shear stress from left ventricular assist devices induces von Willebrand factor degradation and platelet dysfunction, leading to nonsurgical bleeding. We characterized the hemostatic changes induced by 2 centrifugal left ventricular assist devices, the HeartMate 3 (Abbott Inc, Chicago, Ill) and the EVAHEART (Evaheart Inc, Houston, Tex), for comparison. METHODS: Whole blood from 8 healthy volunteers was used ex vivo. Blood from the same donor was used for 6 hours of circulation in a miniature mock-loop system consisting of 2 identical extracorporeal circuits to compare the following experimental settings: (1) optimal revolutions per minute (rpm) for the HeartMate 3 (n = 4; 5000 rpm) and the EVAHEART (n = 4; 2500 rpm) and (2) equal rpm (3000 rpm for the HeartMate 3 and EVAHEART, n = 4 vs n = 4). For both settings, blood flow was adjusted to 1 mock-loop filling volume per minute (HeartMate 3 = 82 mL/min, EVAHEART = 100 mL/min). A panel of coagulation markers was analyzed to investigate hemostatic changes. RESULTS: The free plasma hemoglobin concentration was significantly lower in the EVAHEART compared with the HeartMate 3 after 6 hours of mock-loop circulation under both settings (optimal: 37 ± 31 vs 503 ± 173 mg/dL, P < .0001; equal: 27 ± 4 vs 139 ± 135 mg/dL, P = .024). Loss of von Willebrand factor high-molecular-weight multimers occurred in both left ventricular assist devices and settings, but the von Willebrand factor:activity/von Willebrand factor:antigen ratio after 6 hours was significantly lower in optimal settings for the HeartMate 3 (P = .009). The thrombin-antithrombin complex level was significantly lower with the EVAHEART for both settings (P < .0001). CONCLUSIONS: The EVAHEART left ventricular assist device caused less hemolysis, resulted in lower coagulation activation, and provided better preservation of von Willebrand factor functional activity compared with the HeartMate 3 device. These findings prove that left ventricular assist device design plays a major role in minimizing blood damage during left ventricular assist device support.

Synchronous or Staged Carotid Endarterectomy and Coronary Artery Bypass Grafting? Propensity score matched study.

BACKGROUND: The optimal treatment strategy in patients presenting with hemodynamically significant carotid artery disease who are to undergo cardiac surgery, remains controversial. In this study, we retrospectively analyzed the outcome data of patients receiving synchronous or staged coronary artery bypass graft (CABG) surgery and carotid endarterectomy (CEA). METHODS: Between 2011 and 2016, 3173 patients underwent CABG surgery in our institution, of whom 323 received CABG and CEA either as synchronous (N = 307) or as staged (N = 16) procedures. Patients´ characteristics, peri- and postoperative data were collected from our digital medical database. Propensity score matching was used to match each patient from the staged group to two appropriate patients (1:2 matching) from the synchronous group (synchronousmatched). RESULTS: The overall incidence of ischemic stroke (IS) and transitory ischemic attack (TIA) was 4.9% and 5.6%, respectively. No hemorrhagic stroke was noted in both groups. Incidence of IS did not differ significantly between matched groups (P = 1.000). Significantly higher rates of postoperative neurological complications, such as TIA and delirium, were found in the synchronousmatched group (P = .041 and P = .043, respectively) compared with the staged group. Additionally, there were more postoperative respiratory insufficiencies in the synchronousmatched group (P = .043). Thirty days mortality did not differ significantly between the matched groups. CONCLUSION: In this experience combined with the data given in literature, our findings suggest a possible superiority of the staged CABG/CEA approach. Large, randomized studies are required to verify our findings and to establish applicable guidelines.

Sildenafil Reduces the Risk of Thromboembolic Events in HeartMate II Patients with Low-Level Hemolysis and Significantly Improves the Pulmonary Circulation.

Low-level hemolysis (LLH) after left ventricular assist device implantation contributes to thromboembolic events (TE). Free plasma hemoglobin (fHb) scavenges nitric oxide (NO), which causes endothelial dysfunction and activates platelets. fHb also interacts with von Willebrand factor (vWF). We hypothesized that improved hemodynamic and enhanced NO signaling in HeartMate II (HMII) patients with LLH taking the phosphodiesterase-5 inhibitor sildenafil may reduce the risk of TE.From 2011 to 2015, 83 patients underwent HMII implantation. Patients with LLH as defined by elevated lactate dehydrogenase (400 < LDH ≤ 700 U/L) at hospital discharge were identified. Patients were categorized into 4 groups: 1) LLH + sildenafil, 2) LLH no sildenafil, 3) no LLH + sildenafil, and 4) no LLH no sildenafil. Adverse event-free survival was compared between the groups.Thirty-four patients (40.9%) were discharged with LLH and 22 (64.7%) of them took sildenafil. LDH and fHb remained significantly elevated in both LLH groups compared to the no LLH patients (P < 0.0001). Overall incidence of pump thrombosis (PT) was 4.8% and of ischemic stroke (IS) was 8.4%. HMII patients with LLH not on sildenafil had higher risk of TE (hazard ratio (HR): 14.4, 95%-CI: 1.8-117.1, P = 0.001). vWF activity and bleeding incidence did not differ between the LLH and no LLH patients. Mean pulmonary artery pressure and pulmonary vascular resistance decreased significantly in HMII taking sildenafil (P < 0.0001) while cardiac index increased (P < 0.0001).Sildenafil treatment among HMII patients with LLH reduced the risk of thromboembolic events and significantly improved and decompressed the pulmonary circulation during HMII support.

The Effect of Ultrasound-Assisted Debridement Combined with Vacuum Pump Therapy in Deep Sternal Wound Infections.

PURPOSE: To assess whether a combined treatment of low-frequency (25 kHz) ultrasonic-debridement systems followed by vacuum-assisted wound closure (VAC) produces a better outcome in deep sternal wound infections (SWIs) compared to that of VAC alone. METHODS: We evaluated 45 consecutive patients (25 males) between January 2013 and December 2016, in whom deep SWI was treated with a combination of low-frequency ultrasonic debridement system followed by vacuum-assisted closure (group A, n = 23) or with only vacuum-assisted closure therapy (group B, n = 22). Our final step in both groups was a secondary wound closure with a musculocutaneous flap. RESULTS: In both groups, a similar variety of bacteria were isolated. The time between eradication and secondary wound closure was significantly shorter in group A (7.3 ± 4.8 vs. 19.9 ± 17.2 days, p = 0.001). After a third debridement session, 95.7% of microbiological cultures were negative in group A versus 54.5% in B ( p = 0.001). Duration of antibiotic treatment ( p = 0.003) and hospitalization time ( p = 0.0001) were significantly shorter in group A. CONCLUSION: The use of low-frequency ultrasonic debridement system is an effective, less invasive technique to combat wound infection. In combination with vacuum-assisted closure therapy, we documented good mid-term results in our patients.

Are elevated serum haemolysis markers a harbinger of adverse events in HeartMate II patients?

OBJECTIVES: Haemolysis during left ventricular assist device support is associated with thrombosis. In this retrospective study, we analysed whether low-level haemolysis (LLH) as defined by simultaneously elevated lactate dehydrogenase (LDH) and free haemoglobin (fHb) levels had an impact on thromboembolic and bleeding events and on von Willebrand factor levels in HeartMate II patients. METHODS: After exclusion of patients with LDH >700 U/l and fHb >40 mg/dl at hospital discharge, 79 HeartMate II patients were included. LDH and fHb levels were measured at discharge and in 3 months interval. von Willebrand factor activity and antigen activity were measured 3 months postoperatively. Outcomes regarding ischaemic stroke (IS), pump thrombosis (PT) and gastrointestinal bleeding were recorded. Patients with LLH (400 < LDH ≤ 700 U/l and 30 < fHb ≤ 40 mg/dl) at discharge (pre-Hemolyzers) were compared with the rest of the cohort (non-Hemolyzers). Competing risk analysis and Cox regression were applied for the comparison between groups. RESULTS: In all, 20% of the patients were identified as pre-Hemolyzers. Of these, 5 patients had PT and 3 patients had IS compared with 2 PT and 2 IS in the non-Hemolyzers group (P = 0.003 and P = 0.053, respectively). Fifty percent of the pre-Hemolyzers suffered gastrointestinal bleeding compared with 42% of the non-Hemolyzers (P = 0.399). The cumulative risk of thromboembolic events (IS or PT) in the pre-Hemolyzers group was significantly higher compared with the non-Hemolyzers group (hazard ratio 11.8, 95% confidence interval 3.7-37.7; P = 0.005). LLH did not have an impact on von Willebrand factor and the incidence of gastrointestinal bleeding. CONCLUSIONS: LLH as assessed by elevated fHb and LDH values at discharge during HeartMate II support is associated with thromboembolic events.

Survival of HeartMate II Patients Despite Cessation of Anticoagulation　- Outcomes and Hemostatic Analysis.

BACKGROUND: In long-term left ventricular assist device (LVAD) therapy, recurrent bleeding events may justify cessation of anticoagulation therapy (AT). However, data about THE safety and risks of AT cessation in LVAD patients are scarce.Methods and Results:Between 2010 and 2015, 128 patients received a HeartMate II (HMII). Following recurrent bleeding events, we ceased vitamin K antagonist (VKA) therapy in 13 patients (10%) (no-VKA group). To characterize the hemostatic profile, we performed von Willebrand factor (vWF), platelet function (PF), and other hemostatic tests in all HMII patients. The incidence of pump thrombosis (PT), ischemic stroke (IS) and bleeding events in this HMII population was 4.7 %, 6.2% and 36.7%, respectively. Median survival without VKA was 435 days. No cases of PT and only 1 of IS occurred after AT discontinuation. All patients had impaired PF and acquired von Willebrand syndrome (AvWS). However, the vWF collagen-binding activity to antigen ratio before and after VKA cessation was significantly lower in the no-VKA group compared with the HMII population (0.60±0.12 vs. 0.73±0.14, P=0.006). The thrombin-antithrombin III complex (TAT) value was significantly higher in the no-VKA group (P=0.0005). CONCLUSIONS: We experienced good results with AT cessation in specific HMII patients. The simultaneous onset of AvWS and high TAT values could explain at least in part the low thromboembolic rate in HMII patients without VKA.

A core outcome set for adult cardiac surgery trials: A consensus study.

BACKGROUND: Invasive off- or on-pump cardiac surgery (elective and emergency procedures, excluding transplants are routinely performed to treat complications of ischaemic heart disease. Randomised controlled trials (RCT) evaluate the effectiveness of treatments in the setting of cardiac surgery. However, the impact of RCTs is weakened by heterogeneity in outcome measuring and reporting, which hinders comparison across trials. Core outcome sets (COS, a set of outcomes that should be measured and reported, as a minimum, in clinical trials for a specific clinical field) help reduce this problem. In light of the above, we developed a COS for cardiac surgery effectiveness trials. METHODS: Potential core outcomes were identified a priori by analysing data on 371 RCTs of 58,253 patients. We reached consensus on core outcomes in an international three-round eDelphi exercise. Outcomes for which at least 60% of the participants chose the response option "no" and less than 20% chose the response option "yes" were excluded. RESULTS: Eighty-six participants from 23 different countries involving adult cardiac patients, cardiac surgeons, anaesthesiologists, nursing staff and researchers contributed to this eDelphi. The panel reached consensus on four core outcomes: 1) Measure of mortality, 2) Measure of quality of life, 3) Measure of hospitalisation and 4) Measure of cerebrovascular complication to be included in adult cardiac surgery trials. CONCLUSION: This study used robust research methodology to develop a minimum core outcome set for clinical trials evaluating the effectiveness of treatments in the setting of cardiac surgery. As a next step, appropriate outcome measurement instruments have to be selected.