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.

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.

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?).

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.

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).

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.

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.

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.

Ablation of Atrial Fibrillation With Pulsed Electric Fields: An Ultra-Rapid, Tissue-Selective Modality for Cardiac Ablation.

OBJECTIVES: The authors report the first acute clinical experience of atrial fibrillation ablation with PEF-both epicardial box lesions during cardiac surgery, and catheter-based PV isolation. BACKGROUND: Standard energy sources rely on time-dependent conductive heating/cooling and ablate all tissue types indiscriminately. Pulsed electric field (PEF) energy ablates nonthermally by creating nanoscale pores in cell membranes. Potential advantages for atrial fibrillation ablation include: 1) cardiomyocytes have among the lowest sensitivity of any tissue to PEF-allowing tissue selectivity, thereby minimizing ablation of nontarget collateral tissue; 2) PEF is delivered rapidly over a few seconds; and 3) the absence of coagulative necrosis obviates the risk of pulmonary vein (PV) stenosis. METHODS: PEF ablation was performed using a custom over-the-wire endocardial catheter for percutaneous transseptal PV isolation, and a linear catheter for encircling the PVs and posterior left atrium during concomitant cardiac surgery. Endocardial voltage maps were created pre- and post-ablation. Continuous and categorical data are summarized and presented as mean ± SD and frequencies. RESULTS: At 2 centers, 22 patients underwent ablation under general anesthesia: 15 endocardial and 7 epicardial. Catheter PV isolation was successful in all 57 PVs in 15 patients (100%) using 3.26 ± 0.5 lesions/PV: procedure time 67 ± 10.5 min, catheter time (PEF catheter entry to exit) 19 ± 2.5 min, total PEF energy delivery time <60 s/patient, and fluoroscopy time 12 ± 4.0 min. Surgical box lesions were successful in 6 of 7 patients (86%) using 2 lesions/patient. The catheter time for epicardial ablation was 50.7 ± 19.5 min. There were no complications. CONCLUSIONS: These data usher in a new era of tissue-specific, ultrarapid ablation of atrial fibrillation.

Electrical storm in the early phase of HeartMate® II device implantation: Incidence, risk factors and prognosis.

BACKGROUND: Ventricular arrhythmia is common after left ventricular assist device (LVAD) implantation, especially in the early postoperative phase (<30 days). AIM: To identify the incidence of and risk factors for electrical storm (ES) occurring within 30 days of HeartMate® II implantation. METHODS: We reviewed data from all consecutive patients undergoing HeartMate® II device implantation at our institution from January 2008 to December 2014. Patient demographic data, pharmacotherapies and outcomes were collected. The primary endpoint was occurrence of early ES (within 30 days of surgery), defined as three or more separate episodes of sustained ventricular arrhythmia within a 24-hour interval, requiring appropriate therapy. RESULTS: Forty-three patients (mean age 56.7±11.2 years; 39 men) were included. At HeartMate® II implantation, mean left ventricular ejection fraction was 20±5%, 32 (74.4%) patients had ischaemic cardiomyopathy and 31 (72.1%) were implanted with an indication of bridge to cardiac transplantation. During follow-up, 12 (27.9%) patients experienced early ES after HeartMate® II implantation (median delay 9.1±7.8 days). Early ES was more frequent in larger patients (body surface area 1.99 vs 1.81 m2; P<0.01), tended to be associated with previous sustained ventricular tachycardia (50.0% vs 22.6%; P=0.08), previous implantable cardioverter-defibrillator implantation (66.7% vs 38.7%; P=0.09), discontinuation of long-term beta-blocker therapy (75.0% vs 45.2%; P=0.08), weaning of adrenergic drugs after the third day (66.7% vs 35.5%; P=0.06) and the use of extracorporeal life support (50% vs 22.6%; P=0.079), but was not associated with the cardiomyopathy aetiology or the indication for assistance. Catheter ventricular tachycardia ablation was performed in six (14.0%) patients. Early ES was associated with a significantly higher all-cause mortality rate at the 30th day (33.3% vs 6.5%; P=0.02). CONCLUSION: ES is a common and pejorative feature in the early postoperative period.

Impact of Afterload Increase on Left Ventricular Myocardial Deformation Indices.

BACKGROUND: Left ventricular (LV) afterload could be associated with reduced myocardial contractility. The aim of this study was to evaluate the relative impact of increased afterload on LV myocardial deformation indices in chronic aortic constriction, with regard to hypertrophy, myocardial fibrosis, and mitochondrial function, and to differentiate acute versus chronic afterload effect. METHODS: Young pigs underwent aortic banding (n = 11) or sham (n = 7) operations. Nineteen weeks later, LV morphology and systolic function, including myocardial deformation, were assessed by echocardiography before and after banding release or acute aortic constriction (in the sham group). After the animals were euthanized, mitochondrial function and LV interstitial fibrosis were assessed. RESULTS: The chronic banding group (n = 8) presented with significant LV hypertrophy compared with the sham group (n = 7), and longitudinal strain (LS) was significantly altered (16.9 ± 0.7% vs 20.3 ± 0.7%, P = .001) while circumferential, radial strain, and ejection fraction were not. LS abnormalities were situated mostly on the basal and mid segments and on the septal wall. There was also significantly more myocardial fibrosis in the chronic banding group compared with the sham group, while mitochondrial function was preserved. The relative contributions of hypertrophic and fibrotic remodeling and of afterload to alter global LS were 62%, and 38%, respectively. Acute aortic banding also significantly altered LS. The ratio of LS to septal wall thickness enabled differentiation between chronic and acute afterload increase (1.9 ± 0.2 in the chronic group vs 2.9 ± 0.3 in the acute group, P = .001). CONCLUSIONS: LS is susceptible to both hypertrophic and fibrotic remodeling and afterload increase, particularly on the basal and mid LV segments of the septum. The ratio of LS to septal wall thickness enables differentiation of acute from chronic afterload LS alteration.

Characteristics of ventricular tachycardia ablation in patients with continuous flow left ventricular assist devices.

BACKGROUND: Left ventricular assist devices (LVADs) are increasingly used as a bridge to cardiac transplantation or as destination therapy. Patients with LVADs are at high risk for ventricular arrhythmias. This study describes ventricular arrhythmia characteristics and ablation in patients implanted with a Heart Mate II device. METHODS AND RESULTS: All patients with a Heart Mate II device who underwent ventricular arrhythmia catheter ablation at 9 tertiary centers were included. Thirty-four patients (30 male, age 58±10 years) underwent 39 ablation procedures. The underlying cardiomyopathy pathogenesis was ischemic in 21 and nonischemic in 13 patients with a mean left ventricular ejection fraction of 17%±5% before LVAD implantation. One hundred and ten ventricular tachycardias (VTs; cycle lengths, 230-740 ms, arrhythmic storm n=28) and 2 ventricular fibrillation triggers were targeted (25 transseptal, 14 retrograde aortic approaches). Nine patients required VT ablation <1 month after LVAD implantation because of intractable VT. Only 10/110 (9%) of the targeted VTs were related to the Heart Mate II cannula. During follow-up, 7 patients were transplanted and 10 died. Of the remaining 17 patients, 13 were arrhythmia-free at 25±15 months. In 1 patient with VT recurrence, change of turbine speed from 9400 to 9000 rpm extinguished VT. CONCLUSIONS: Catheter ablation of VT among LVAD recipients is feasible and reasonably safe even soon after LVAD implantation. Intrinsic myocardial scar, rather than the apical cannula, seems to be the dominant substrate.

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.

Comparison of delayed transvenous reimplantation and immediate surgical epicardial approach in pacing-dependent patients undergoing extraction of infected permanent pacemakers.

BACKGROUND: Pacemaker infection in pacing-dependent patients is challenging. After extraction, temporary pacing usually is utilized before delayed reimplantation (after an appropriate course of antibiotics), resulting in prolonged hospital stays. A single combined procedure of epicardial (EPI) pacemaker implantation and system extraction may prevent this. OBJECTIVE: The purpose of this study was to evaluate the feasibility and safety of these 2 approaches by comparing clinical outcome for both strategies over 1 year. METHODS: In center 1, 80 consecutive pacemaker-dependent patients underwent extraction with an externalized pacemaker and delayed implantation on the contralateral side (ENDO group). In center 2, 80 consecutive patients had 2 epicardial ventricular leads surgically implanted with extraction of the infected pacemaker during the same procedure (EPI group). Patients were followed-up for 12 months. RESULTS: One hundred sixty pacing-dependent patients were successfully implanted and extracted (ENDO group 71 ± 13 years vs EPI group 73 ± 14, P = NS). In the EPI group, 2 patients developed significant pericardial bleeding. In-hospital mortality was 0% in the ENDO group and 2.5% in the EPI group. Total hospitalization time was 15 ± 7 days in the ENDO group vs 9 ± 6 days in the EPI group (P <.001). At 1 year, no infection recurrences occurred in either group, and mortality was equal (5% in each group). Median 1-year pacing thresholds were lower in the ENDO vs the EPI group (0.8 ± 0.6 V vs 1.1 ± 0.6 V, P = .02). CONCLUSION: The ENDO and EPI strategies had an excellent success rate and low risk of complications. A single procedure using surgical epicardial lead implantation was associated with a shorter duration of hospital stay.

Electrophysiological study 6 months after Epicor™ high-intensity focused ultrasound atrial fibrillation ablation.

PURPOSE: Little is presently known about the outcome of atrial lesions performed with high-intensity focused ultrasound (HIFU) for atrial fibrillation ablation. We aimed to assess endocardial atrial lesions 6 months after epicardial HIFU ablation (Epicor(™)) and to evaluate the benefit of a combined ablation approach. METHODS: Thirty patients (21 males, mean age 68 ± 12 years old) undergoing HIFU atrial fibrillation ablation during cardiac surgery were enrolled. Electrophysiological study (EPS) was performed 6 months after HIFU ablation, and endovascular radiofrequency was delivered in case of conduction gaps. Patients were followed up for at least 6 months after the EPS. RESULTS: At EPS, ten patients (38 %) had achieved complete or near-complete "box" isolation and four (15 %) had no visible lesion. Using this technology, freedom from symptomatic atrial arrhythmia at 6 months was 60 % (n = 18/30) (64 % for paroxysmal and 56 % for persistent subgroups) improving to 81 % (n = 21/26) (90 % for paroxysmal and 73 % for persistent subgroups) at 12 months after a facultative percutaneous endocardial approach was performed. Using an UltraCinch device sized below 10 improved the rate of complete lesion as assessed 6 months after surgery (58 % of complete or near-complete box isolation with UltraCinch device <10 vs 21 % when ≥11; p = 0.05). CONCLUSION: Six months after HIFU ablation, only 38 % of the patients had complete or near-complete box isolation, and the recurrence rate of symptomatic atrial arrhythmia was 40 %. The latter was reduced to 19 % 6 months after complementary percutaneous approach.

Assessment of platelet function with light transmission aggregometry in 24 patients supported with a continuous-flow left ventricular assist device: a single-center experience.

OBJECTIVES: This study evaluated platelet function for an extended period of time in patients with a HeartMate II continuous-flow left ventricular assist device (Thoratec Corporation, Pleasanton, Calif) with light transmission aggregometry and investigated the potential role of this test in clinical management. METHODS: Twenty-four patients were studied prospectively after implantation. Mean duration of support was 8.5 months. Platelet functions were assessed with light transmission aggregometry induced by thrombin receptor agonist peptide, ristocetin, or arachidonic acid. All patients received an aspirin regimen that was progressively increased until arachidonic acid-triggered platelet aggregation dropped lower than 20%. Plasma levels of von Willebrand factor were also determined when ristocetin-induced platelet agglutination was impaired. RESULTS: Intensity of platelet aggregation with thrombin receptor agonist peptide was little changed in patients with a HeartMate II relative to control subjects. Aspirin dose greater than 160 mg/d was progressively required in 46% of patients. Ristocetin-induced platelet agglutination was impaired in 4 patients in association with a lack of high molecular weight von Willebrand factor multimers. Three patients had thromboembolic events (12.5%) and 8 (33%) suffered from major bleeding complications. CONCLUSIONS: High platelet reactivity during treatment with aspirin is common in patients with a HeartMate II. Moreover, light transmission aggregometry may detect impaired ristocetin-induced platelet agglutination, enabling dosage of aspirin to be adjusted. Our strategy showed no major improvements in terms of thrombosis rate when compared with published data, although bleeding frequency was somewhat reduced. Benefits of light transmission aggregometry testing need to be assessed in a larger randomized study with a longer follow-up.