Independent risk factors for ICU mortality after left ventricular assist device implantation.

Left ventricular assist devices (LVADs) are used as an alternative therapy for heart transplantation in patients with advanced heart failure. However, the mortality rate of these patients remains relatively high. A large proportion of deaths after LVAD implantation occur during intensive care unit (ICU) stay. We conducted a retrospective study to identify the risk factors for all-cause ICU mortality in patients with an implanted LVAD. Between January 1, 2008 and December 31, 2016, 70 consecutive patients who had received an LVAD were analyzed. The median ICU length of stay was 14 days (IQR: 8-31) and 16 patients (22.9% [95%CI: 13.1-32.7]) died in the ICU. The 90-day mortality rate was 25.7% (95%CI: 15.5-35.9). The main causes of ICU mortality were: multiple organ failure, stroke, and hemorrhagic events. The univariate analysis identified the following perioperative risk factors for all-cause ICU mortality: hypertension, preoperative platelet count, preoperative white cell count, inotropic support before LVAD implantation, mechanical ventilation before LVAD implantation, renal replacement therapy before LVAD implantation, short-term mechanical support before LVAD implantation, INTERMACS class 1 to 2, low intraoperative platelet count, low early postoperative hemoglobin level, low early postoperative platelet count, low early postoperative pH, and massive perioperative blood transfusion. In the multivariate logistic regression analysis, only mechanical ventilation before LVAD implantation was retained as an independent risk factor for ICU mortality (OR = 11.96 [95%CI: 2.67-53.45], P < .01). These findings confirm that most deaths after LVAD implantation occur in the ICU. Patients that receive mechanical ventilation preoperatively have the highest risk of death. This confirms the need to actively treat respiratory failure and to wean patients from respiratory support before LVAD implantation. Such a strategy offers the best opportunity to initiate active rehabilitation.

Left ventricle reconstruction and heartmate3 implantation. The "double patch technique".

BACKGROUND: HeartMate 3 is a left ventricular assist device, composed of a centrifugal pump. It can be applied as a myocardial recovery, a bridge to transplant, or a destination therapy, in the treatment of patients with left ventricular heart failure. METHODS: Herein we describe a technique applied against a giant aneurysmal dilatation, which combines a surgical device implantation and a left ventricular reconstruction using a double patch. RESULTS: The patch minimizes thrombotic risk thanks to its internal bovine pericardium layer, which is in contact with blood. CONCLUSIONS: The outlined technique is relatively reproducible and safe in a selected group of patients, as it employs a high-quality device and enables the restoration of an appropriate ventricular geometry.

Risk factors and prognostic impact of left ventricular assist device-associated infections.

BACKGROUND: Left ventricular assist device (LVAD)-associated infections may be life-threatening and impact patients' outcome. We aimed to identify the characteristics, risk factors, and prognosis of LVAD-associated infections. METHODS: Patients included in the ASSIST-ICD study (19 centers) were enrolled. The main outcome was the occurrence of LVAD-associated infection (driveline infection, pocket infection, or pump/cannula infection) during follow-up. RESULTS: Of the 652 patients enrolled, 201 (30.1%) presented a total of 248 LVAD infections diagnosed 6.5 months after implantation, including 171 (26.2%), 51 (7.8%), and 26 (4.0%) percutaneous driveline infection, pocket infection, or pump/cannula infection, respectively. Patients with infections were aged 58.7 years, and most received HeartMate II (82.1%) or HeartWare (13.4%). Most patients (62%) had implantable cardioverter-defibrillators (ICDs) before LVAD, and 104 (16.0%) had ICD implantation, extraction, or replacement after the LVAD surgery. Main pathogens found among the 248 infections were Staphylococcus aureus (n = 113' 45.4%), Enterobacteriaceae (n = 61; 24.6%), Pseudomonas aeruginosa (n = 34; 13.7%), coagulase-negative staphylococci (n = 13; 5.2%), and Candida species (n = 13; 5.2%). In multivariable analysis, HeartMate II (subhazard ratio, 1.56; 95% CI, 1.03 to 2.36; P = .031) and ICD-related procedures post-LVAD (subhazard ratio, 1.43; 95% CI, 1.03-1.98; P = .031) were significantly associated with LVAD infections. Infections had no detrimental impact on survival. CONCLUSIONS: Left ventricular assist device-associated infections affect one-third of LVAD recipients, mostly related to skin pathogens and gram-negative bacilli, with increased risk with HeartMate II as compared with HeartWare, and in patients who required ICD-related procedures post-LVAD. This is a plea to better select patients needing ICD implantation/replacement after LVAD implantation.

Infections in patients using ventricular-assist devices: Comparison of the diagnostic performance of 18F-FDG PET/CT scan and leucocyte-labeled scintigraphy.

BACKGROUND: The usage of left-ventricular-assist device (LVAD) is increasing in patients presenting with advanced heart failure. However, device-related infections are a challenge to recognize and to treat, with an important morbidity and mortality rate. The role of nuclear medicine imaging remains not well established for LVAD infections. The present study compared the accuracy of positron emission tomography/computed tomography with 18F-fludeoxyglucose (18F-FDG PET/CT) and radiolabeled leucocyte scintigraphy for the diagnosis of infections in patients supported with a continuous-flow LVAD. METHODS: From a prospectively maintained database, we retrospectively analyzed the diagnostic performance of radiolabeled leucocyte scintigraphy and 18F-FDG PET/CT in 24 patients who had a LVAD with a suspected device-related infection. Both examinations were routinely performed in all patients. Infection was assessed by the International Society for Heart and Lung Transplantation criteria. RESULTS: Twenty-four patients were included: 15 had a specific VAD infection (5 cardiac-LVAD and 10 driveline), 6 had a VAD-related infection, while 3 patients had a non-VAD-related infection. Sensitivity, specificity, positive predictive value, negative predictive value, and accuracy were 95.2%, 66.7%, 95.2%, 66.7%, and 91.6%, respectively, for 18F-FDG-PET; and 71.4%, 100%, 100%, 33.3%, and 75%, respectively, for leucocyte scintigraphy. 18F-FDG PET/CT showed significantly higher sensitivity (P = 0.01) than leucocyte scintigraphy. CONCLUSION: 18F-FDG PET/CT and radiolabeled leucocyte scintigraphy single-photon emission computed tomography carry high performance in the diagnostic of LVAD infections. 18F-FDG PET/CT shows significantly higher sensitivity and could be proposed as first-line nuclear medicine procedure.

The use of Impella 2.5 in severe refractory cardiogenic shock complicating an acute myocardial infarction.

OBJECTIVES: To investigate the outcome of patients with acute myocardial infarction (AMI) complicated by refractory cardiogenic shock (CS) who underwent mechanical circulatory support with Impella 2.5. BACKGROUND: AMI complicated by CS remains a highly fatal condition. A potent and minimally invasive left ventricular assist device might improve patient outcomes. METHODS: We analyzed the procedural characteristics and outcomes of 22 consecutive patients who underwent, between July 2008 and December 2012, a percutaneous coronary intervention and Impella 2.5 support for AMI complicated by CS refractory to first-line therapy with inotropes and/or Intra-aortic balloon pump. RESULTS: In this analysis, patients were relatively young with a mean age of 57.9 ± 11.6 year old and 59.1% were male. The majority of patients (77.3%) were admitted in CS and 40.9% sustained cardiac arrest prior to admission. Hemodynamics improved significantly upon initiation of support, end-organ and tissue perfusion improved subsequently demonstrated by a significant decrease in lactate levels from 6.37 ± 5.3 mmol/L to 2.41 ± 2.1 mmo/L, (P = 0.008) after 2 days of support. Thirteen (59.1%) patients were successfully weaned-off Impella 2.5 and 4 (18.2%) were transitioned to another device. We observed a functional recovery of the left ventricle when compared to baseline (43 ± 10% vs. 27 ± 9%, P < 0.0001). The survival rate at 6 months and 1 year was 59.1% and 54.5%, respectively. CONCLUSION: Impella 2.5 was initiated as a last resort therapy to support very sick patients with refractory CS after failed conventional therapy. The use of the device yielded favorable short and mid-term survival results with recovery being the most frequently observed outcome.

Predicting fluid responsiveness during infrarenal aortic cross-clamping in pigs.

OBJECTIVE: Infrarenal aortic cross-clamping (ACC) induces hemodynamic disturbances that may affect respiratory-induced variations in stroke volume and, therefore, affect the ability of dynamic parameters such as pulse-pressure variation (PPV) to predict fluid responsiveness. Since this issue has not been investigated yet to authors' knowledge, the hypothesis was tested that ACC may change PPV and impair its ability to predict fluid responsiveness. DESIGN: Prospective laboratory experiment. SETTING: A university research laboratory. PARTICIPANTS: Nineteen anesthetized and mechanically ventilated pigs. INTERVENTIONS: Two courses of volume expansion were performed using 500 mL of saline before and during ACC. Animals were monitored using a systemic arterial catheter, and a pulmonary arterial catheter (stroke volume, central venous pressure, pulmonary arterial occlusion pressure). Animals were defined as responders to volume expansion if stroke volume increased ≥ 15%. RESULTS: Before ACC, 13 animals were responders. Fluid responsiveness was predicted by a PPV ≥ 14% with a sensitivity of 77% (95% CI = 46%-95%) and a specificity of 83% (95% CI = 36%-97%). The area under the receiver operating characteristic curve was 0.90(95% CI = 0.67-0.99) and was higher than those generated for central venous pressure and pulmonary arterial occlusion pressure. ACC induced an increase in PPV (p<0.0005). During ACC, 8 animals were responders. An 18% PPV threshold discriminated between responders and non-responders to volume expansion, with a sensitivity of 87% (95% CI = 47%-98%) and a specificity of 54% (95% CI = 23%-83%). The area under the receiver operating characteristic curve was 0.72 (95% CI = 0.47-0.90) and was not different from those generated for central venous pressure and pulmonary arterial occlusion pressure. CONCLUSIONS: ACC induced a significant increase in PPV and reduced its ability to predict fluid responsiveness.

Cardiopulmonary bypass during a second-lung implantation improves postoperative oxygenation after sequential double-lung transplantation.

OBJECTIVES: During sequential double-lung transplantation (DLT), the newly implanted first lung receives the entire cardiac output during the implantation of the second one. This may be responsible for the increased hydrostatic pressure that causes severe interstitial and alveolar edema that can lead to allograft dysfunction. The authors tested the hypothesis that CPB started after first graft implantation and before second recipient lung removal should improve post-transplantation oxygenation and clinical outcomes. DESIGN: Observational during 2 consecutive 1-year periods. SETTING: University hospital. PARTICIPANTS: Nine consecutive patients undergoing sequential DLT with CPB started after first graft implantation and before second recipient lung removal were compared to controls, who were 10 consecutive patients who underwent sequential DLT but without CPB the year before. MEASUREMENTS AND MAIN RESULTS: Oxygenation after transplantation was assessed. The use of CPB during the implantation of the second lung was associated with an increased mean postoperative ratio of PaO2 to the fraction of inspired oxygen at 1 hour (363±51 v 240±113, p = 0.01) and 6 hours (430±111 v 280±103, p = 0.03). The mean duration of CPB was 111±19 min. The occurrence of primary graft dysfunction and the need for extracorporeal membrane oxygenation tended to be lower, but did not reach significance. Similarly, mortality rate was comparable between both groups, as was the rate of blood transfusions. CONCLUSIONS: The authors' results suggest that the use of CPB started after first graft implantation and before second recipient lung removal appears to benefit oxygenation and reduces the occurrence of severe pulmonary edema in the first transplanted lung.

Secreted frizzled-related protein-1 improves postinfarction scar formation through a modulation of inflammatory response.

OBJECTIVE: The inflammatory response after myocardial infarction plays a crucial role in the healing process. Lately, there is accumulating evidence that the Wnt/Frizzled pathway may play a distinct role in inflammation. We have shown that secreted frizzled-related protein-1 (sFRP-1) overexpression reduced postinfarction scar size, and we noticed a decrease in neutrophil infiltration in the ischemic tissue. We aimed to further elucidate the role of sFRP-1 in the postischemic inflammatory process. METHODS AND RESULTS: We found that in vitro, sFRP-1 was able to block leukocyte activation and cytokine production. We transplanted bone marrow cells (BMCs) from transgenic mice overexpressing sFRP-1 into wild-type recipient mice and compared myocardial healing with that of mice transplanted with wild-type BMCs. These results were compared with those obtained in transgenic mice overexpressing sFRP-1 specifically in endothelial cells or in cardiomyocytes to better understand the spatiotemporal mechanism of the sFRP-1 effect. Our findings indicate that when overexpressed in the BMCs, but not in endothelial cells or cardiomyocytes, sFRP-1 was able to reduce neutrophil infiltration after ischemia, by switching the balance of pro- and antiinflammatory cytokine expression, leading to a reduction in scar formation and better cardiac hemodynamic parameters. CONCLUSION: sFRP-1 impaired the loop of cytokine amplification and decreased neutrophil activation and recruitment into the scar, without altering the neutrophil properties. These data support the notion that sFRP-1 may be a novel antiinflammatory factor protecting the heart from damage after myocardial infarction.

Fast track echo of abdominal aortic aneurysm using a real pocket-ultrasound device at bedside.

BACKGROUND: Ultraminiaturization of echographic systems extraordinarily provides the image "within" the clinical examination. Abdominal aorta aneurysm (AAA) diagnosis based on conventional evaluation with a dedicated operator and ultrasound machine is still controversial due to the lack of evidence of the proposed management and guidelines' cost-effectiveness. We hypothesized that less expensive ultraportable devices could identify AAA with the same level of accuracy as conventional approaches. METHODS: A first step of this study was to validate the VSCAN's image capabilities in patients referred to the vascular Doppler laboratory. Abdominal aorta measurements were performed by an experienced physician using conventional equipment followed by a second blinded physician using the ultraportable device VSCAN. Then, 204 patients hospitalized in our cardiology institute were prospectively included for a systematic screening of AAA at bedside using the VSCAN in order to determine the feasibility and impact of fast track evaluation compared to clinical examination. RESULTS: A strong correlation was obtained between measurements of abdominal aorta diameters using the two ultrasound systems (r = 0.98, CI: 0.97-0.99, P < 0.001) with 100% of agreement for AAA diagnosis. In the second part of the study, visualization and measurement of the transverse diameter of the abdominal aorta was obtained in 199 patients, resulting in a feasibility of 97.5%. Among these patients, 18 AAAs were detected, which corresponds to a prevalence of 9%, whereas clinical evaluation did not detect any of them. Patients with AAA were more likely men (77.77% vs. 57.45%, P < 0.05) and hypertensive (88.8% vs. 56.9%, P < 0.05) as compared to those without AAA. Two patients with large AAA were quickly referred to the surgery department. CONCLUSION: Considering its low cost, diagnostic accuracy, and widespread availability, screening for AAA using an ultraportable ultrasound device such as VSCAN by an experienced physician is promising and should be used as an extension of routine physical examination in vascular patients.

Optimization of Impella 5.0 implantation using mini-sternotomy approach in postmyocardial infarction cardiogenic shock.

The Impella Recover LP 5.0® (Abiomed, Inc. Danvers, MA, USA) is an aortic transvalvular microaxial pump designed to unload the left ventricle and to ensure a systemic flow in severe left ventricular dysfunction. Surgical implantation using femoral or right subclavian approach may be difficult in certain circumstances, such as encountered in peripheral vascular disease, patients with small vessels or during substantial use of vasoactive drugs responsible for vasospasm. We propose a simple and effective technique for implantation of the Impella 5.0 LVAD by means of a mini-sternotomy in patients with postinfarction refractory cardiogenic shock.

Unilateral versus bilateral cerebral perfusion during aortic surgery for acute type A aortic dissection: a multicentre study.

OBJECTIVES: The aim of this retrospective multicentre study was to investigate and compare clinical outcomes of unilateral and bilateral antegrade cerebral perfusion (ACP) strategies on cerebral protection during surgery for type A aortic dissection. METHODS: Data from 646 patients who underwent surgical repair of thoracic type A aortic dissection using unilateral and bilateral ACP with moderate hypothermic circulatory arrest in 3 cardiac surgical institutions between 2008 and 2018 were analysed. Propensity matching was performed to assess which technique ensured better outcomes. RESULTS: Unilateral and bilateral ACP techniques were performed in 250 (39%) and in 396 (61%) patients, respectively. Propensity score analysis identified 189 matched pairs. In the matched cohort, the lowest core temperature was 27.5°C and 28°C in the bilateral and unilateral groups, respectively (P < 0.001). The unilateral technique required significantly shorter aortic cross-clamp and cardiopulmonary bypass times than bilateral technique [82 min vs 100 min (P < 0.001); 170 min vs 195 min (P < 0.001)]. The 30-day mortality was comparable (P = 0.325). The bilateral group reported a significantly higher incidence of permanent neurologic deficits (P < 0.001), left brain hemisphere stroke (P = 0.007) and all-combined complications (P < 0.001). Ten-year survival was comparable (P = 0.45). CONCLUSIONS: Unilateral and bilateral ACP are both valid brain protection strategies in the landscape of aortic arch surgery. While admitting all the study limitations, unilateral technique could offer some clinical advantages. CLINICAL REGISTRATION NUMBER: 76049.

Long-term outcomes after pocket or scar revision and reimplantation of pacemakers with preerosion.

INTRODUCTION: Cardiac pacemakers with preerosion are often reimplanted. Preerosion may be caused by an evolving local infectious process affecting the entire pacing system or by mechanical migration of the device causing ischemic necrosis of the skin tissues. We examined the long-term outcome of 33 patients who underwent pocket or scar revision and submuscular reimplantation of cardiac pacemakers in our institution. METHODS: Before undergoing pocket or scar revision and reimplantation, all patients (1) had negative serial blood cultures, (2) had no vegetation on transesophageal echocardiography, (3) had a normal blood C-reactive protein concentrations, (4) were afebrile, (5) had no cutaneous breakthrough, and (6) presented with preerosion of the pulse generator or granulomatous-like scar abnormality. RESULTS: THE mean follow-up was 37 ± 12 months. Among 16 patients presenting with preerosion associated with signs of local cutaneous inflammation, 62.5% developed an infection of the pacing system requiring later explantation. Of eight patients presenting initially with migration of the pulse generator and mechanical protrusion, none required subsequent explantation of the system. Among nine patients presenting initially with granulomatous-like scar abnormalities, 55.6% underwent explantation of the pacing system during follow-up for management of documented local infection. CONCLUSIONS: The reimplantation of pulse generators with preerosion in the presence of local inflammatory manifestations or granulomatous-like changes of the scar is complicated by documented cardiac pacemaker infection in >50% of cases. In these patients, the explantation of the pacing system is recommended before the development of prognostically much more serious spread of infection to the leads and cardiac tissues.

Beating-heart coronary artery bypass surgery with the help of mini extracorporeal circulation for very high-risk patients.

BACKGROUND: Left ventricle dysfunction and co-morbidities are responsible for a large number of complications after coronary artery bypass graft (CABG) surgery. The best strategy for these patients, including the use or not and type of extracorporeal circulation (ECC), the use of minimized ECC (MECC), or conventional ECC (CECC), remains unclear. The aim of the present study was to investigate the potential effect of on-pump beating-heart (OPBH) surgery with the help of MECC for CABG in patients with a high-risk EuroSCORE and to compare this strategy to three other different procedures, including OPCAB and MECC or CECC with cardiac arrest. METHODS: Patients were included if their EuroSCORE was strictly >" xbd="1427" xhg="1404" ybd="1477" yhg="1440"/>9. Four groups were retrospectively compared: an OPCAB, an OPBH, a MECC and a CECC group under cardiac arrest. RESULTS: 214 patients, mean age 74.26 ± 8.5 years, 68.7% male, were operated. Mean EuroSCORE was 12.1 ± 2.9, left ventricular (LV) function 37.4 ± 12.3%, recent myocardial infarction (MI) 49.5%, renal failure 48.1%, chronic obstructive pulmonary disease (COPD) 42.2%, and peripheral vascular disease (PVD) 55.6%. Mean number of grafts per patient was 2.4 ± 0.7. Our study showed that it was possible, in very high-risk patients, to carry out revascularisation with OPBH similar to that using MECC or CECC under cardiac arrest (p=NS). This technique reduces troponin release (3.23 vs 6.56, p<0.01), postoperative myocardial complications (2% vs 8%, p<0.01), cardiotonic drug prescription (15.7% vs 31.3%, p<0.01), ventilation time (4.57H vs 6.48H, p<0.01) and length of stay (LOS) in ICU (2.16 vs 2.53, p=0.02). CONCLUSION: The OPBH method seems to be safe, secure and effective in this population of very high-risk patients, reducing early complications and multi-organ failure. OPBH surgery, combining MECC without aortic cross-clamping, makes it possible to perform complete revascularization and is an interesting alternative for CABG in high-risk patients.

Rapid-deployment aortic valve replacement in high-risk patients with severe endocarditis.

BACKGROUND: Surgical management of aortic valve endocarditis in high risk patients is controversial and the ideal treatment has not been found yet. We describe a selected series of eight patients treated with rapid-deployment aortic valve prosthesis as a therapeutic solution for minimizing the risks associated with annulus manipulation in case of severe aortic infective endocarditis. METHODS: Eight consecutive patients (five men and three women) with a mean age of 74.3±7.2 years, mean logistic EuroSCORE II of 16.0%±0.1%, affected by aortic native (1 patient), or prosthetic valve endocarditis (7 patients), were treated with Edwards Intuity Elite implantation. Hemodynamic performance and infective data were collected pre-, intra-, and postoperatively with a mean follow-up of 2.7±0.7 years. RESULTS: One case of in-hospital mortality was noted. None of the patients had any embolic or infective complication postoperatively. The cardiopulmonary bypass and aortic cross-clamp times were 148.4±41.6 and 90.5±25.3 min, respectively. The postoperative echocardiographic controls indicated a mean transvalvular gradient of 16.7±3.0 mmHg and one case of paravalvular leaks (2 +). Two patients underwent epigastric permanent pacemaker implantation. During the follow-up, seven patients were alive, with no evidence of symptoms or recurrences of endocarditis or embolic episodes. No new paravalvular leaks were noted, and the mean gradient on the valves was 12.4±3.4 mmHg. CONCLUSIONS: Rapid deployment aortic valve replacement in selected very high-risk patients affected by infective endocarditis could be a reasonable choice with acceptable results. However, further studies are needed to confirm these results.

Current results of left ventricular assist device therapy in France: the ASSIST-ICD registry.

OBJECTIVES: Our goal was to provide a picture of left ventricular assist device (LVAD) activity in France between 2007 and 2016 based on the multicentric ASSIST-ICD registry. METHODS: We retrospectively collected 136 variables including in-hospital data, follow-up survival rates and adverse events from 671 LVAD recipients at 20 out of 24 LVAD implant centres in France. The average follow-up time was 1.2 years (standard deviation: 1.4); the total follow-up time was 807.5 patient-years. RESULTS: The included devices were the HeartMate II®, HeartWare LVAS® or Jarvik 2000®. The overall likelihood of being alive while on LVAD support or having a transplant (primary end point) at 1, 2, 3 and 5 years postimplantation was 65.2%, 59.7%, 55.9% and 47.7%, respectively, given a cumulative incidence of 29.2% of receiving a transplant at year 5. At implantation, 21.5% of patients were on extracorporeal life support. The overall rate of cardiogenic shock at implantation was 53%. The major complications were driveline infection (26.1%), pump pocket or cannula infection (12.6%), LVAD thrombosis (12.2%), ischaemic (12.8%) or haemorrhagic stroke (5.4%; all strokes 18.2%), non-cerebral haemorrhage (9.1%) and LVAD exchange (5.2%). The primary end point (survival) was stratified by age at surgery and by the type of device used, with inference from baseline profiles. The primary end point combined with an absence of complications (secondary end point) was also stratified by device type. CONCLUSIONS: The ASSIST-ICD registry provides a real-life picture of LVAD use in 20 of the 24 implant centres in France. Despite older average age and a higher proportion of patients chosen for destination therapy, survival rates improved compared to those in previous national registry results. This LVAD registry contrasts with other international registries because patients with implants have more severe disease, and the national policy for graft attribution is distinct. We recommend referring patients for LVAD earlier and suggest a discussion of the optimal timing of a transplant for bridged patients (more dismal results after the second year of support?).

Contributions of advanced techniques to the success and safety of transvenous leads extraction.

PURPOSE: We measured the proportion of intravascular leads, which can be extracted by simple traction versus with newer techniques, and examined the overall safety and success rate of lead extractions. METHODS: Between January 2005 and December 2007, 311 consecutive patients (mean age = 70 +/- 14 years, 79% men) underwent extractions of 250 atrial, 318 ventricular, and 22 coronary sinus leads, in the surgical facilities of two experienced medical centers, under general anesthesia, at a mean of 7.2 +/- 5.1 years (range 0.1-27.0) after lead implantation. Infection was the indication for extraction in 67.5% of cases. Complementary techniques were used when simple extraction with a locking stylet was unsuccessful. RESULTS: Simple traction, with or without a locking stylet, allowed the complete removal in 27.0% (95% confidence interval [CI] 22.1-31.9) of patients. A mechanical sheath, laser sheath, and/or lasso catheter were used in the remaining patients. The overall extraction success rate was 89.7% (95% CI 86.3-93.1). There was one procedure-related death (0.3%; 95% CI 0.0-1.0). Among five other deaths occurring within 10 days after the procedure, four were due to septic shock. Duration of lead implantation was the strongest independent predictor of major adverse events (P = 0.002) and incomplete lead extraction (P = 0.005). CONCLUSION: In contrast with simple traction, advanced techniques allowed the complete extraction of nearly 90% of leads. In experienced hands and with surgical back-up, these techniques were safe. Patients presenting with infected implanted cardiac devices suffered a high rate of major adverse despite complete extraction of the lead(s).

Aortic root surgery with the CARDIOROOT vascular graft: results of a prospective multicenter post-market surveillance study.

BACKGROUND: Sparing Aortic Valve procedure requires to reproduction of the geometry of the physiologic anatomy of the aortic root. Thus, the materials adopted may make a difference. CARDIOROOT is a one-piece collagen-coated woven vascular graft with pseudo-sinuses, which was designed for use in the treatment of aortic root disease. We report the results of a prospective, multicenter, observational post-market surveillance study evaluating the safety and performance of the CARDIOROOT in patients requiring aortic root surgery. METHODS: Patients with aortic root disease suitable for treatment with a vascular graft with pseudo-sinuses CARDIOROOT graft were eligible for participation. The enrolled patients were assessed intraoperatively, post-operatively, at discharge and at 1-year. Sites assessed complications at each visit, and recorded any reported adverse events. The study endpoint was mortality and complications through 1-year post-procedure. RESULTS: Fifty-two patients were enrolled from 6 European centers. All procedures were technically successful. Operative mortality was 1.9%: one patient suffered hemorrhagic shock unrelated to the graft 1 day following surgery. At 1-year follow-up the survival rate was 96.2%, with a late death due to pneumonia 5 months post-procedure. Eleven serious adverse events occurred in 7 patients, which included cardiac complications (pericardial effusion, myocardial infarction and ventricular arrhythmia), infection (pericardial infection, deep sternal infection and superficial sternal infection), vascular disorders, including hemorrhagic shock and pleural effusion requiring drainage. Nine of the 11 events were deemed procedure-related by the local investigator, and all were deemed unrelated to the device. There were no reports of graft-related adverse events, infection, occlusion or graft failure. CONCLUSIONS: The results of this 1-year follow-up study showed that the CARDIOROOT vascular graft is safe and effective for the treatment of aneurysmal aortic root in immediate and mid-term follow-up. However, longer term follow-up is needed before conclusions can be made on the long-term safety and effectiveness. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01609270. Registered 31 May 2012.

Early Ventricular Arrhythmias After LVAD Implantation Is the Strongest Predictor of 30-Day Post-Operative Mortality.

OBJECTIVES: This study aimed to evaluate incidence, clinical significance, and predictors of early ventricular arrhythmias (VAs) in left ventricular assist device (LVAD) recipients. BACKGROUND: LVAD implantation is increasingly used in patients with end-stage heart failure. Early VAs may occur during the 30-day post-operative period, but many questions remain unanswered regarding their incidence and clinical impact. METHODS: This observational study was conducted in 19 centers between 2006 and 2016. Early VAs were defined as sustained ventricular tachycardia and/or ventricular fibrillation occurring <30 days post-LVAD implantation and requiring appropriate implantable cardioverter-defibrillator therapy, external electrical shock, or medical therapy. RESULTS: A total of 652 patients (median age: 59.8 years; left ventricular ejection fraction: 20.7 ± 7.4%; HeartMate 2: 72.8%; HeartWare: 19.5%; Jarvik 2000: 7.7%) were included in the analysis. Early VAs occurred in 162 patients (24.8%), most frequently during the first week after LVAD implantation. Multivariable analysis identified history of VAs prior to LVAD and any combined surgery with LVAD as 2 predictors of early VAs. The occurrence of early VAs with electrical storm was the strongest predictor of 30-day post-operative mortality, associated with a 7-fold increase of 30-day mortality. However, in patients discharged alive from hospital, occurrence of early VAs did not influence long-term survival. CONCLUSIONS: Early VAs are common after LVAD implantation and increase 30-day post-operative mortality, without affecting long-term survival. Further studies will be needed to analyze whether pre- or pre-operative ablation of VAs may improve post-operative outcomes. (Determination of Risk Factors of Ventricular Arrhythmias After Implantation of Continuous Flow Left Ventricular Assist Device With Continuous Flow Left Ventricular Assist Device [ASSIST-ICD]; NCT02873169).