Alain Pavie

Transcatheter aortic valve implantation: early results of the FRANCE (FRench Aortic National CoreValve and Edwards) registry

AIMS Transcatheter aortic valve implantation is a therapeutic alternative for high-surgical-risk patients with severe symptomatic aortic stenosis. Two models of prosthesis are currently commercialized in France, which can be implanted either via a transarterial or a transapical approach. The aim of the study was to evaluate in a national French registry the early safety and efficacy of transcatheter aortic valve replacement (AVR) using either the Edwards SAPIEN™ or CoreValve™ in high-surgical-risk patients with severe aortic stenosis. METHODS AND RESULTS The multicentre national registry was conducted in 16 centres between February 2009 and June 2009, under the authority of the French Societies of Cardiology and Thoracic and Cardio-Vascular Surgery. The primary endpoint was mortality at 1 month. Two hundred and forty-four high-surgical-risk patients (logistic EuroSCORE ≥20%, STS ≥10%, or contra-indication to AVR) were enrolled. Mean age was 82 ± 7 years and 43.9% were female. Edwards SAPIEN and CoreValve were implanted in 68 and 32% of patients, respectively. The approaches used were transarterial (transfemoral: 66%; subclavian: 5%) or transapical in 29%. Device success rate was 98.3% and 30-day mortality was 12.7%. Severe complications included stroke (3.6%), tamponade (2%), acute coronary occlusion (1.2%), and vascular complications (7.3%). Pacemaker was required in 11.8%. At 1 month, 88% of patients were in NYHA class II or less. CONCLUSION This prospective registry reflects the real-life experience of transcatheter aortic valve implantation in high-risk elderly patients in France. The early results are satisfactory in terms of feasibility, short-term haemodynamic and functional improvement, and safety. Longer term follow-up will be further assessed.

Pacemaker infective endocarditis

We identified 33 patients with definite pacemaker endocarditis--that is, with direct evidence of infective endocarditis, based on surgery or autopsy histologic findings of or bacteriologic findings (Gram stain or culture) of valvular vegetation or electrode-tip wire vegetation. Most of the patients (75%) were > or = 60 years of age (mean 66 +/- 3; range 21 to 86). Pouch hematoma or inflammation was common (58%), but other predisposing factors for endocarditis were rare. At the time that pacemaker endocarditis was found, the mean number of leads was 2.4 +/- 1.1 (range 1 to 7). The interval from the last procedure to diagnosis of endocarditis was 20 +/- 4 months (range 1 to 72). Endocarditis appeared after pacemaker implantation, early (< 3 months) in 10 patients and late (> or = 3 months) in 23 patients. Fever was the most common symptom, being isolated in 36%, associated with a poor general condition in 24%, and associated with septic shock in 9%. Transthoracic echocardiography showed vegetations in only 2 of 9 patients. Transesophageal echocardiography demonstrated the presence of lead vegetations (n = 20) or tricuspid vegetations (n = 3) in 23 of 24 patients (96%; p <0.0001 compared with transthoracic echocardiography). Pulmonary scintigraphy showed a typical pulmonary embolization in 7 of 17 patients (41%). Pathogens were mainly isolated from blood (82%) and lead (91%) cultures. The major pathogens causing pacemaker endocarditis were Staphylococcus epidermidis (n = 17) and S. aureus (n = 7). S. epidermidis was found more often in early than in late endocarditis (90% vs 50%; p = 0.05). All patients were treated with prolonged antibiotic regimens before and after electrode removal. Electrode removal was achieved by surgery (n = 29) or traction (n = 4). Associated procedures were performed in 9 patients. After the intensive care period, only 17 patients needed a new permanent pacemaker. Overall mortality was 24% after a mean follow-up period of 22 +/- 4 months (range 1 to 88). Eight patients who were significantly older (74 +/- 3 vs 63 +/- 3 years; p = 0.05) died < or = 2 months after electrode removal, whereas 25 were alive and asymptomatic.

Guideline on antiplatelet and anticoagulation management in cardiac surgery

This document presents a professional view of evidence-based recommendations around the issues of antiplatelet and anticoagulation management in cardiac surgery. It was prepared by the Audit and Guidelines Committee of the European Association for Cardio-Thoracic Surgery (EACTS). We review the following topics: evidence for aspirin, clopidogrel and warfarin cessation prior to cardiac surgery; perioperative interventions to reduce bleeding including the use of aprotinin and tranexamic acid; the use of thromboelastography to guide blood product usage; protamine reversal of heparin; the use of factor VIIa to control severe bleeding; anticoagulation after mechanical, tissue valve replacement and mitral valve repair; the use of antiplatelets and clopidogrel after cardiac surgery to improve graft patency and reduce thromboembolic complications and thromboprophylaxis in the postoperative period. This guideline is subject to continuous informal review, and when new evidence becomes available. The formal review date will be at 5 years from publication (September 2013).

Mechanical Circulatory Support for Advanced Heart Failure

Background—Use of wearable left ventricular assist systems (LVAS) in the treatment of advanced heart failure has steadily increased since 1993, when these devices became generally available in Europe. The aim of this study was to identify in an unselected cohort of LVAS recipients those aspects of patient selection that have an impact on postimplant survival. Methods and Results—Data were obtained from the Novacor European Registry. Between 1993 and 1999, 464 patients were implanted with the Novacor LVAS. The majority had idiopathic (60%) or ischemic (27%) cardiomyopathy; the median age at implant was 49 (16 to 75) years. The median support time was 100 days (4.1 years maximum). Forty-nine percent of the recipients were discharged from the hospital on LVAS; they spent 75% of their time out of the hospital. For a subset of 366 recipients, for whom a complete set of data was available, multivariate analysis revealed that the following preimplant conditions were independent risk factors for survival after LV...

Emergency circulatory support in refractory cardiogenic shock patients in remote institutions: a pilot study (the cardiac-RESCUE program)

AIMS Temporary circulatory support with extracorporeal membrane oxygenation (ECMO) is often the only alternative for supporting patients with refractory cardiogenic shock (RCS). In practice, this strategy is limited to a small minority of patients hospitalized in tertiary-care centres with ECMO programs. The cardiac-RESCUE program was designed to test the feasibility of providing circulatory support distant from specialized ECMO centres, for RCS patients in remote locations. METHODS AND RESULTS From January 2005 to December 2009, hospitals without ECMO facilities throughout the Greater Paris area were invited to participate. One hundred and four RCS cases were assessed and 87 consecutively eligible patients (mean age 46 ± 15 years, 41% following cardiac arrest) had ECMO support instituted locally and were enrolled into the program. Local initiation of ECMO support allowed successful transfer to the tertiary-care centre in 75 patients. Of these, 32 patients survived to hospital discharge [overall survival rate 36.8%, 95% confidence interval (CI) 27.4-46.2]. Independent predictors for in-hospital mortality included initiation of ECMO during cardiopulmonary resuscitation [hazard ratio (HR) = 4.81, 95% CI 2.25-10.30, P < 0.001] and oligo-anuria (HR = 2.48, 95% CI 1.29-4.76, P = 0.006). After adjusting for other confounding factors, in-hospital mortality was not statistically different from that of 123 consecutive patients who received ECMO at our institution during the same period (odds ratio 1.48, 95% CI 0.72-3.00, P = 0.29). CONCLUSION Offering local ECMO support appears feasible in a majority of RCS patients hospitalized in remote hospitals. In this otherwise lethal situation, our pilot experience suggests that over one-third of such patients can survive to hospital discharge.

Early Percutaneous Tracheotomy Versus Prolonged Intubation of Mechanically Ventilated Patients After Cardiac Surgery: A Randomized Trial

BACKGROUND Whether early percutaneous tracheotomy in patients who require prolonged mechanical ventilation can shorten mechanical ventilation duration and lower mortality remains controversial. OBJECTIVE To compare the outcomes of severely ill patients who require prolonged mechanical ventilation randomly assigned to early percutaneous tracheotomy or prolonged intubation. DESIGN Prospective, randomized, controlled, single-center trial (ClinicalTrials.gov registration number: NCT00347321). SETTING Academic center. PATIENTS 216 adults requiring mechanical ventilation 4 or more days after cardiac surgery. INTERVENTION Immediate early percutaneous tracheotomy or prolonged intubation with tracheotomy 15 days after randomization. MEASUREMENTS The primary end point was the number of ventilator-free days during the first 60 days after randomization. Secondary outcomes included 28-, 60-, or 90-day mortality rates; durations of mechanical ventilation, intensive care unit stay, and hospitalization; sedative, analgesic, and neuroleptic use; ventilator-associated pneumonia rate; unscheduled extubations; comfort and ease of care; and long-term health-related quality of life (HRQoL) and psychosocial evaluations. RESULTS There was no difference in ventilator-free days during the first 60 days after randomization between early percutaneous tracheotomy and prolonged intubation groups (mean, 30.4 days [SD, 22.4] vs. 28.3 days [SD, 23.7], respectively; absolute difference, 2.1 days [95% CI, -4.1 to 8.3 days]) nor in 28-, 60-, or 90-day mortality rates (16% vs. 21%, 26% vs. 28%, and 30% vs. 30%, respectively). The durations of mechanical ventilation and hospitalization, as well as frequencies of ventilator-associated pneumonia and other severe infections, were also similar. However, early percutaneous tracheotomy was associated with less intravenous sedation; less time of heavy sedation; less haloperidol use for agitation, delirium, or both; fewer unscheduled extubations; better comfort and ease of care; and earlier resumption of oral nutrition. After a median follow-up of 873 days, between-group survival, psychosocial evaluations, and HRQoL were similar. LIMITATION The prolonged intubation group had more ventilator-free days during days 1 to 60 than what was hypothesized (mean, 23.0 days [SD, 17.0]). CONCLUSION Early tracheotomy provided no benefit in terms of mechanical ventilation and length of hospital stay, rates of mortality or infectious complications, and long-term HRQoL for patients who require prolonged mechanical ventilation after cardiac surgery. However, the well-tolerated procedure was associated with less sedation, better comfort, and earlier resumption of autonomy. PRIMARY FUNDING SOURCE French Ministry of Health.

Cardiac Tumors: Clinical Experience and Surgical Results in 74 Patients

A series of 75 cardiac tumors in 74 patients were operated on at La Pitie Hospital between 1972 and 1989. There were 73 primary and 2 metastatic tumors. Among the benign neoplasms, 58 were myxomas; seven of the nine malignant tumors were primary heart tumors. The mean age of the patients was 48 years (range, 9 to 75 years); 46 patients were female and 28 male. Fifty-seven percent of the patients had congestive heart failure, 13% had chest pain, 17% had neurological symptoms, and only 1 patient was totally asymptomatic. The cardiac tumors were incidental findings in 3 patients. Complete resection was carried out in 66 benign lesions and only four of the malignant tumors. All patients survived operation, although 4 died in the early postoperative period. Long-term results were excellent in patients with benign lesions, and no recurrences were found. In patients with malignant tumors, surgical procedures were only palliative and aimed at prolonging life; hence, prognosis remained unchanged.

European results with a continuous-flow ventricular assist device for advanced heart-failure patients §

OBJECTIVE The HeartMate II (HM II) LVAD is a small, quiet, continuous-flow, left ventricular assist device (LVAD) for circulatory support in advanced heart-failure patients, with over 2000 implants worldwide. This article reports on the European experience with this device. METHODS The HM II was implanted in 571 patients at 64 European institutions. In 72% of cases (411 patients), implantation has taken place at least 6 months before the closing date of the study (1 August 2008). Patients (19% female, 70% ischaemic aetiology) were on maximum medical therapy, including inotropic support. Body surface area ranged from 1.30 to 2.50 m(2) and age from 14 to 75 years (mean: 51+/-14 years; n=115, 28% over age 60 years). The intention of support was to provide a bridge to transplantation (73%), destination therapy (21%) and a bridge to recovery (6%). Adverse events were documented in the first 53 patients - for obtaining the Conformité Européenne (CE) Mark (group A) - from a European multicentric study (Strüber et al. [Strüber M, Sander K, Lahpor J, Ahn H, Litzler P-Y, Drakos SG, Musumeci F, Schlensak C, Friedrich I, Gustafsson R, Oertel F, Leprince P. HeartMate II left ventricular assist device; early European experience. Eur J Cardiovasc Surg 2008;34(2):289-94.]: 101 patients) and from a single-centre study (UMCU, The Netherlands: 30 patients). RESULTS The mean support duration ranged from 0 to 1019 days with a mean of 236+/-214 days (249 patients: >6 months, 119: 1 year, 12: >2 years; total support time: 293 years). The overall survival to transplantation, recovery or ongoing device support at the end of the study was 69% (284) with an early mortality of 17.5% and late mortality of 13.5%. Of the surviving patients, 23% have been transplanted, 4% had their device removed after recovery of the left ventricle and 42% are still ongoing. Adverse events included bleeding (ranging from 42% in group C to 59% in group A), percutaneous lead infections (A: 0.19, B: 0.61 and C: 0.18 events per patient year), pocket infections (A: 0.08, B: 0.07 and C: 0.09 events per patient year), ischaemic stroke (A: 0.06, B: 0.09 and C: 0.04 events per patient year), haemorrhagic stroke (B: 0.07, C: 0.04 events per patient year) and transient ischaemic attacks (TIAs; A: 0.08, B: 0.02 and C: 0.13 events per patient year). CONCLUSIONS These results support the use of the HM II continuous-flow LVAD for long-term support as a bridge to transplantation and possibly for destination therapy. Future emphasis should focus on minimising adverse events such as infections, bleeding and neurological events.

Venoarterial extracorporeal membrane oxygenation support for refractory cardiovascular dysfunction during severe bacterial septic shock.

Objectives:Profound myocardial depression can occur during severe septic shock. Although good outcomes of venoarterial extracorporeal membrane oxygenation–treated children with refractory septic shock have been reported, little is known about adults’ outcomes. This study was designed to assess the outcomes and long-term health-related quality-of-life of patients supported by venoarterial extracorporeal membrane oxygenation for refractory cardiac and hemodynamic failure during severe septic shock. Design:A retrospective, single-center, observational study and a cross-sectional survey to assess health-related quality of life by the Short Form-36 questionnaire and frequencies of anxiety, depression and posttraumatic stress disorder symptoms by the Hospital Anxiety and Depression Scale and the Impact of Event Scale, respectively. Setting:A 26-bed tertiary intensive care unit in a university hospital. Patients:We evaluated the outcomes of patients who received venoarterial extracorporeal membrane oxygenation rescue therapy for refractory cardiovascular failure during bacterial septic shock. Results are expressed as medians (range). Measurements and Main Results:From January 2008 to September 2011, 14 patients, 45 years old (28–66), seven males, none with a history of left ventricular dysfunction, received venoarterial extracorporeal membrane oxygenation for septic shock refractory to conventional treatment, 24 hours (3–108) after shock onset. All exhibited severe myocardial dysfunction at extracorporeal membrane oxygenation implantation. Left ventricular ejection fraction was 16% (10% to 30%), cardiac index was 1.3 L/min/m2 (0.7–2.2 ) and systemic resistance vascular index was 3162 (2047–7685). All were receiving high-dose catecholamines and had signs of multiple organ failure: pH 7.16 (6.68–7.39), blood lactate 9 (2–17) mmol/L, PaO2/FIO2 87 (28–364), Simplified Acute Physiology Score III 84 (75–106) and Sepsis-Related Organ Failure Assessment score 18 (8–21). Twelve patients (86%) could be weaned off venoarterial extracorporeal membrane oxygenation after 5.5 days (2–12) days of support and 10 patients (71%) were discharged to home and were alive after a median follow-up of 13 months (3–43). All 10 survivors had normal left ventricular ejection fraction and reported good health-related quality of life at long-term follow-up. Conclusions:Venoarterial extracorporeal membrane oxygenation rescued more than 70% of the patients who developed refractory cardiovascular dysfunction during severe bacterial septic shock. Survivors reported good long-term quality of life. Venoarterial extracorporeal membrane oxygenation might represent a valuable therapeutic option for adults in severe septic shock with refractory cardiac and hemodynamic failure.

Outcomes, long-term quality of life, and psychologic assessment of fulminant myocarditis patients rescued by mechanical circulatory support

Objective:Myocarditis is a rare disease that may progress rapidly to refractory cardiogenic shock and death. In such situations, emergent initiation of mechanical circulatory assistance is the only therapeutic option to rescue these dying patients. This study was designed to evaluate the outcomes, health-related quality of life and frequencies of anxiety, depression and posttraumatic stress disorder symptoms in fulminant myocarditis patients rescued by mechanical circulatory assistance, since these major components of outcome evaluation after serious illnesses have not yet been assessed in this setting. Design:A retrospective, single-center, observational study and a cross-sectional survey to assess health-related quality of life by the Short Form-36 questionnaire and frequencies of anxiety, depression and posttraumatic stress disorder symptoms by the Hospital Anxiety and Depression Scale and the Impact of Event Scale, respectively. Setting:An 18-bed tertiary intensive care unit in a university hospital. Patients:We analyzed the short- and long-term outcomes of 41 patients hospitalized at our institution between 2003 and 2009 and who received either a Thoratec BiVAD (Thoratec, Pleasanton, CA) (n = 6) or extracorporeal membrane oxygenation (n = 35) to combat refractory cardiogenic shock due to fulminant myocarditis. Measurements and Main Results:Intensive care unit survival was 68%, and four (10%) patients underwent heart transplantation. Independent predictors of in-intensive care unit death were Simplified Acute Physiology Score II ≥56 (odds ratio = 10.23) and troponin Ic ≥12 &mgr;g/L (odds ratio = 7.49) at admission. Complete follow-up (median, 525 days) was available for 26 of 28 survivors. Compared to age- and sex-matched controls, Short Form-36 evaluation of health-related quality of life revealed satisfactory mental health and vitality but persistent physical and psychosocial-related difficulties. Lastly, anxiety, depression, and/or posttraumatic stress disorder symptoms were reported by 38%, 27% and 27% of the patients, respectively. Conclusions:Mechanical circulatory assistance rescued 68% of patients with refractory circulatory failure due to fulminant myocarditis. Greater disease severity and higher troponin Ic levels at extracorporeal membrane oxygenation initiation predicted poorer prognosis. Because up to one-third of the patients reported anxiety, depression, and/or posttraumatic stress disorder symptoms, strategies aimed at attenuating their emotional and psychologic distress might significantly improve their long-lasting well-being.