Publications by authors named "Pierre Yves Litzler"

50 Publications

Comparison of Outcomes and Mortality in Patients Having Left Ventricular Assist Device Implanted Early -vs- Late After Diagnosis of Cardiomyopathy.

Am J Cardiol 2021 05 4;146:82-88. Epub 2021 Feb 4.

Department of Cardiology and Cardiac Surgery, AP-HP CHU Henri Mondor, Créteil, France.

LVAD implantation in patients with a recently diagnosed cardiomyopathy has been poorly investigated. This work aims at describing the characteristics and outcomes of patients receiving a LVAD within 30 days following the diagnosis of cardiomyopathy. Patients from the ASSIST-ICD study was divided into recently and remotely diagnosed cardiomyopathy based on the time from initial diagnosis of cardiomyopathy to LVAD implantation using the cut point of 30 days. The primary end point of the study was all-cause mortality at 30-day and during follow-up. A total of 652 patients were included and followed during a median time of 9.1 (2.5 to 22.1) months. In this population, 117 (17.9%) had a recently diagnosed cardiomyopathy and had LVAD implantation after a median time of 15.0 (9.0 to 24.0) days following the diagnosis. This group of patients was significantly younger, with more ischemic cardiomyopathy, more sudden cardiac arrest (SCA) events at the time of the diagnosis and were more likely to receive temporary mechanical support before LVAD compared with the remotely diagnosed group. Postoperative in-hospital survival was similar in groups, but recently diagnosed patients had a better long-term survival after hospital discharge. SCA before LVAD and any cardiac surgery combined with LVAD implantation were identified as 2 independent predictors of postoperative mortality in recently diagnosed patients. In conclusion, rescue LVAD implantation for recently diagnosed severe cardiomyopathy is common in clinical practice. Such patients experience a relatively low postoperative mortality and have a better long-term survival compared with remotely diagnosed patients.
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http://dx.doi.org/10.1016/j.amjcard.2021.01.027DOI Listing
May 2021

Hemolysis induced by Left Ventricular Assist Device is associated with proximal tubulopathy.

PLoS One 2020 30;15(11):e0242931. Epub 2020 Nov 30.

Nephrology-Kidney Transplant Unit, Rouen University Hospital, Rouen, France.

Background: Chronic subclinical hemolysis is frequent in patients implanted with Left Ventricular Assist Device (LVAD) and is associated with adverse outcomes. Consequences of LVADs-induced subclinical hemolysis on kidney structure and function is currently unknown.

Methods: Thirty-three patients implanted with a Heartmate II LVAD (Abbott, Inc, Chicago IL) were retrospectively studied. Hemolysis, Acute Kidney Injury (AKI) and the evolution of estimated Glomerular Filtration Rate were analyzed. Proximal Tubulopathy (PT) groups were defined according to proteinuria, normoglycemic glycosuria, and electrolytic disorders. The Receiver Operating Characteristic (ROC) curve was used to analyze threshold of LDH values associated with PT.

Results: Median LDH between PT groups were statistically different, 688 IU/L [642-703] and 356 IU/L [320-494] in the "PT" and "no PT" groups, respectively p = 0.006. To determine PT group, LDH threshold > 600 IU/L was associated with a sensitivity of 85.7% (95% CI, 42.1-99.6) and a specificity of 84.6% (95% CI, 65.1-95.6). The ROC's Area Under Curve was 0.83 (95% CI, 0.68-0.98). In the "PT" group, patients had 4.2 [2.5-5.0] AKI episodes per year of exposure, versus 1.6 [0.4-3.7] in the "no PT" group, p = 0.03. A higher occurrence of AKI was associated with subsequent development of Chronic Kidney Disease (CKD) (p = 0.02) and death (p = 0.05).

Conclusions: LVADs-induced subclinical hemolysis is associated with proximal tubular functional alterations, which in turn contribute to the occurrence of AKI and subsequent CKD. Owing to renal toxicity of hemolysis, measures to reduce subclinical hemolysis intensity as canula position or pump parameters should be systematically considered, as well as specific nephroprotective therapies.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0242931PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7703997PMC
January 2021

Relation of Body Mass Index to Outcomes in Patients With Heart Failure Implanted With Left Ventricular Assist Devices.

Am J Cardiol 2020 10 6;133:81-88. Epub 2020 Aug 6.

Department of Cardiology and cardiac surgery, University Hospital, Dijon, France.

We aimed at characterizing the impact of low and high body mass index (BMI) on outcomes after left-ventricular assist device (LVAD) surgery and define the predictors of mortality in patients with abnormal BMI (low/high). This study was conducted in 19 centers from 2006 to 2016. Patients were divided based on their baseline BMI into 3 groups of BMI: low (BMI ≤18.5 kg/m²); normal (BMI = 18.5 to 24.99 kg/m²) and high (BMI ≥25 kg/m²) (including overweight (BMI = 25 to 29.99 kg/m²), and obesity (BMI ≥30 Kg/m²)). Among 652 patients, 29 (4.4%), 279 (42.8%) and 344 (52.8%) had a low-, normal-, and high BMI, respectively. Patients with high BMI were significantly more likely men, with more co-morbidities and more history of ventricular/supra-ventricular arrhythmias before LVAD implantation. Patients with abnormal BMI had significantly lower survival than those with normal BMI. Notably, those with low BMI experienced the worst survival whereas overweight or obese patients had similar survival. Four predictors of mortality for LVAD candidates with abnormal BMI were defined: total bilirubin ≥16 µmol/L before LVAD, hypertension, destination therapy, and cardiac surgery with LVAD. Depending on the number of predictor per patients, those with abnormal BMI may be divided in 3 groups of 1-year mortality risk, i.e., low (0 to 1 predictor: 29% and 31%), intermediate (2 to 3 predictors, 51% and 52%, respectively), and high (4 predictors: 83%). In conclusion, LVAD recipients with abnormal BMI experience lower survival, especially underweight patients. Four predictors of mortality have been identified for LVAD population with abnormal BMI, differentiating those a low-, intermediate-, and high risks of death.
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http://dx.doi.org/10.1016/j.amjcard.2020.07.045DOI Listing
October 2020

Implantable cardiac defibrillator leads dysfunction after LVAD implantation.

Pacing Clin Electrophysiol 2020 11 24;43(11):1309-1317. Epub 2020 Jul 24.

Department of Cardiology and Cardiac Surgery, AP-HP CHU Henri Mondor, Créteil, France.

Background: Implantable cardioverter-defibrillator (ICD) lead dysfunction has been reported after left ventricular assist device (LVAD) implantation in limited single-center studies. We aimed at describing and characterizing the incidence of ICD lead parameters dysfunction after LVAD implantation.

Methods: Among the 652 patients enrolled in the ASSIST-ICD study, only patients with an ICD prior to LVAD were included (n = 401). ICD lead parameters dysfunction following LVAD implantation is defined as follows: (a) >50% decrease in sensing threshold, (b) pacing lead impedance increase/decrease by >100Ω, and (c) >50% increase in pacing threshold.

Results: One hundred twenty-two patients with an ICD prior to LVAD had available ICD interrogation reports prior and after LVAD. A total of 67 (55%) patients exhibited at least one significant lead dysfunction: 17 (15%) exhibited >50% decrease in right ventricular (RV) sensing, 51 (42%) had >100 Ω increase/decrease in RV pacing impedance, and 24 (20%) experienced >50% increase in RV pacing threshold. A total of 52 patients experienced ventricular arrhythmia during follow-up and all were successfully detected and treated by the device. All lead dysfunction could be managed conservatively.

Conclusion: More than 50% of LVAD-recipients may experience >1 significant change in lead parameters but none had severe clinical consequences.
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http://dx.doi.org/10.1111/pace.14004DOI Listing
November 2020

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

Eur J Cardiothorac Surg 2020 07;58(1):112-120

Department of Cardiac Surgery, Marie Lannelongue Hospital, Paris Sud University, Le Plessis Robinson, France.

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?).
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http://dx.doi.org/10.1093/ejcts/ezaa055DOI Listing
July 2020

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

Eur J Cardiothorac Surg 2020 07;58(1):112-120

Department of Cardiac Surgery, Marie Lannelongue Hospital, Paris Sud University, Le Plessis Robinson, France.

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?).
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http://dx.doi.org/10.1093/ejcts/ezaa055DOI Listing
July 2020

Incidence, predictors, and clinical impact of electrical storm in patients with left ventricular assist devices: New insights from the ASSIST-ICD study.

Heart Rhythm 2019 10 27;16(10):1506-1512. Epub 2019 Jun 27.

Department of Cardiology and Cardiac Surgery, University Hospital, Dijon, France.

Background: Ventricular arrhythmias (VAs) can occur after continuous flow left ventricular assist device (LVAD) implantation as a single arrhythmic event or as electrical storm (ES) with multiple repetitive VA episodes.

Objective: We aimed at analyzing the incidence, predictors, and clinical impact of ES in LVAD recipients.

Methods: Patients analyzed were those included in the multicenter ASSIST-ICD observational study. ES was consensually defined as occurrence of ≥3 separate episodes of sustained VAs within a 24-hour interval.

Results: Of 652 patients with an LVAD, 61 (9%) presented ES during a median follow-up period of 9.1 (interquartile range [IQR] 2.5-22.1) months. The first ES occurred after 17 (IQR 4.0-56.2) days post LVAD implantation, most of them during the first month after the device implantation (63%). The incidence then tended to decrease during the initial years of follow-up and increased again after the third year post LVAD implantation. History of VAs before LVAD implantation and heart failure duration > 84 months were independent predictors of ES. The occurrence of ES was associated with an increased early mortality since 20 patients (33%) died within the first 2 weeks of ES. Twenty-two patients (36.1%) presented at least 1 recurrence of ES, occurring 43.0 (IQR 8.0-69.0) days after the initial ES. Patients experiencing ES had a significantly lower 1-year survival rate than did those free from ES (log-rank, P = .039).

Conclusion: There is a significant incidence of ES in patients with an LVAD. The short-term mortality after ES is high, and one-third of patients will die within 15 days. Whether radiofrequency ablation of arrhythmias improves outcomes would require further studies.
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http://dx.doi.org/10.1016/j.hrthm.2019.06.021DOI Listing
October 2019

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

Am Heart J 2019 08 6;214:69-76. Epub 2019 May 6.

Department of Cardiology and cardiac surgery, University Hospital, Dijon, France.

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.
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http://dx.doi.org/10.1016/j.ahj.2019.04.021DOI Listing
August 2019

Assessment of Long-Term Structural Deterioration of Transcatheter Aortic Bioprosthetic Valves Using the New European Definition.

Circ Cardiovasc Interv 2019 04;12(4):e007597

Normandie Univ, UNIROUEN, INSERM U1096, Rouen University Hospital, Department of Cardiology, FHU REMOD-VHF, France (E.D., A.S., C.T., P.Y.L., G.A., A.C., H.E.).

Background: The durability of transcatheter aortic bioprosthetic valves is a crucial issue, but data are scarce, especially beyond 5 years of follow-up. We aimed to assess long-term (7 years) structural valve deterioration (SVD) and bioprosthetic valve failure of transcatheter aortic bioprosthetic valves.

Methods And Results: Consecutive patients with at least 5-year follow-up available undergoing transcatheter aortic valve implantation from April 2002 to December 2011 in 5 French centers were included. Incidence of SVD and bioprosthetic valve failure were defined according to newly standardized criteria of the European Association of Percutaneous Cardiovascular Interventions/European Society of Cardiology/European Association for Cardio-Thoracic Surgery and reported as cumulative incidence function to account for the competing risk of death. One thousand four hundred three consecutive patients were included with a mean age of 82.6±7.5 years and with a mean logistic EuroSCORE (European System for Cardiac Operative Risk Evaluation) of 21.3±7.5%. A balloon-expandable valve was used in 83.7% of cases. Survival rates were 83.5% (95% CI, 81.4%-85.5%) and 18.6% (95% CI, 15.3%-21.8%) at 1 and 7 years, respectively. Median duration of follow-up was 3.9 years. Bioprosthetic valve failure occurred in 19 patients with a 7-year cumulative incidence of 1.9% (95% CI, 1.4%-2.4%). SVD occurred in 49 patients (moderate, n=32; severe, n=17) with a 7-year cumulative incidence of moderate and severe SVD of 7.0% (95% CI, 5.6%-8.4%) and 4.2% (95% CI, 2.9%-5.5%), respectively. Five patients had aortic valve reintervention (1.0%; 95% CI, 0.4%-1.6%) including 1 case of surgical aortic valve replacement and 4 redo-transcatheter aortic valve implantation. The incidences of SVD and bioprosthetic valve failure were not significantly different between balloon and self-expandable prostheses.

Conclusions: The long-term assessment of transcatheter aortic bioprosthetic valves durability is limited by the poor survival of our population beyond 5 years. Further studies are warranted, particularly in younger and lower-risk patients.
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http://dx.doi.org/10.1161/CIRCINTERVENTIONS.118.007597DOI Listing
April 2019

Predictors and Clinical Impact of Late Ventricular Arrhythmias in Patients With Continuous-Flow Left Ventricular Assist Devices.

JACC Clin Electrophysiol 2018 09 25;4(9):1166-1175. Epub 2018 Jul 25.

Department of Cardiology and Cardiac Surgery, AP-HP CHU Henri Mondor, Créteil, France.

Objectives: This study aimed to evaluate the incidence, clinical impact, and predictors of late ventricular arrhythmias (VAs) in left ventricular assist device (LVAD) recipients aiming to clarify implantable cardioverter-defibrillator (ICD) indications.

Background: The arrhythmic risk and need for ICD in patients implanted with an LVAD are not very well known.

Methods: This observational study was conducted in 19 centers between 2006 and 2016. Late VAs were defined as sustained ventricular tachycardia or fibrillation occurring >30 days post-LVAD implantation, without acute reversible cause and requiring appropriate ICD therapy, external electrical shock, or medical therapy.

Results: Among 659 LVAD recipients, 494 (median 58.9 years of age; mean left ventricular ejection fraction 20.7 ± 7.4%; 73.1% HeartMate II, 18.6% HeartWare, 8.3% Jarvik 2000) were discharged alive from hospital and included in the final analysis. Late VAs occurred in 133 (26.9%) patients. Multivariable analysis identified 6 independent predictors of late VAs: VAs before LVAD implantation, atrial fibrillation before LVAD implantation, idiopathic etiology of the cardiomyopathy, heart failure duration >12 months, early VAs (<30 days post-LVAD), and no angiotensin-converting enzyme inhibitors during follow-up. The "VT-LVAD score" was created, identifying 4 risk groups: low (score 0 to 1), intermediate (score 2 to 4), high (score 5 to 6), and very high (score 7 to 10). The rates of VAs at 1 year were 0.0%, 8.0%, 31.0% and 55.0%, respectively.

Conclusions: Late VAs are common after LVAD implantation. The VT-LVAD score may help to identify patients at risk of late VAs and guide ICD indications in previously nonimplanted patients. (Determination of Risk Factors of Ventricular Arrhythmias [VAs] after implantation of continuous flow left ventricular assist device with continuous flow left ventricular assist device [CF-LVAD] [ASSIST-ICD]; NCT02873169).
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http://dx.doi.org/10.1016/j.jacep.2018.05.006DOI Listing
September 2018

Assessment of structural valve deterioration of transcatheter aortic bioprosthetic balloon-expandable valves using the new European consensus definition.

EuroIntervention 2018 06 8;14(3):e264-e271. Epub 2018 Jun 8.

Rouen University Hospital, Department of Cardiology, FHU REMOD-VHF, Rouen, France.

Aims: Durability of transcatheter aortic bioprosthetic valves remains a major issue. Standardised definitions of deterioration and failure of bioprosthetic valves have recently been proposed. The aim of this study was to assess structural transcatheter valve deterioration (SVD) and bioprosthetic valve failure (BVF) using these new definitions.

Methods And Results: All TAVI patients implanted up to September 2012 with a minimal theoretical five-year follow-up were included. Systematic clinical and echocardiographic follow-up was performed annually. New standardised definitions were used to assess durability of transcatheter aortic bioprosthetic valves. From 2002 to 2012, 378 patients were included. Mean age and logistic EuroSCORE were 83.3±6.8 years and 22.8±13.1%. Thirty-day mortality was 13.2%. Nine patients had SVD including two severe forms and two patients had definite late BVF. The incidence of SVD and BVF at eight years was 3.2% (95% CI: 1.45-6.11) and 0.58% (95% CI: 0.15-2.75), respectively.

Conclusions: Even though limited by the poor survival of the very high-risk/compassionate early population, our data do not demonstrate any alarm concerning transcatheter aortic valve durability. Careful prospective assessment in younger and lower-risk patients and comparison with surgical bioprosthetic valves are required for further assessment of the long-term durability of transcatheter valves.
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http://dx.doi.org/10.4244/EIJ-D-18-00015DOI Listing
June 2018

Rerouting the internal thoracic pedicle: a novel solution for maxillofacial reconstruction in vessel-depleted situations? A preliminary anatomic study.

Surg Radiol Anat 2018 Aug 30;40(8):911-916. Epub 2017 Dec 30.

Department of Oral and Maxillofacial Surgery, Rouen University Hospital, Rouen, France.

Purpose: Microsurgical reconstruction in a vessel-depleted neck is a challenge due to the lack of reliable vessels in or nearby the host site. The use of the internal thoracic pedicle (ITP) by rib section or sparring is a limited option due to the small length of the pedicle of some flaps. However, in cardiac surgery, the internal thoracic artery (ITA) is widely used for myocardial revascularization, providing a long and versatile pedicle. We aimed at determining precise anatomical bases for the use of the ITP, approached by sternotomy and rerouted in the neck, as recipient vessels for free-flap facial reconstructions.

Methods: We performed a descriptive single centre anatomical study on 20 formalin-embalmed cadavers. The ITP was harvested on both sides from the emergence of the artery under the brachiocephalic vein to its terminal division. The level reached by the ITP in the cervicofacial area was described. Distal arterial and venous diameters, pedicle length and other parameters were measured.

Results: In at least 85% of the cases, the ITP reached the mandibular angle. The mean diameter at the distal extremity for the ITA was 2.36 ± 0.15, and 2.48 ± 0.19 mm for the committing vein. The mean length of the ITP was 177.3 mm.

Conclusion: Rerouting the ITP towards the cervicofacial area could provide a reliable pedicle for free-flap reconstructions in patients with a vessel-depleted neck but it should be limited to selected patients. This novel solution for situations where current techniques are unfeasible warrants further clinical research.
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http://dx.doi.org/10.1007/s00276-017-1965-1DOI Listing
August 2018

Incidence, Prognostic Impact, and Predictive Factors of Readmission for Heart Failure After Transcatheter Aortic Valve Replacement.

JACC Cardiovasc Interv 2017 12;10(23):2426-2436

Department of Cardiology, Normandie Université, UNIROUEN, Rouen University Hospital, INSERM U1096, Rouen, France.

Objectives: The aim of this study was to assess the incidence, prognostic impact, and predictive factors of readmission for congestive heart failure (CHF) in patients with severe aortic stenosis treated by transcatheter aortic valve replacement (TAVR).

Background: TAVR is indicated in patients with severe symptomatic aortic stenosis in whom surgery is considered high risk or is contraindicated. Readmission for CHF after TAVR remains a challenge, and data on prognostic and predictive factors are lacking.

Methods: All patients who underwent TAVR from January 2010 to December 2014 were included. Follow-up was achieved for at least 1 year and included clinical and echocardiographic data. Readmission for CHF was analyzed retrospectively.

Results: This study included 546 patients, 534 (97.8%) of whom were implanted with balloon-expandable valves preferentially via the transfemoral approach in 87.8% of cases. After 1 year, 285 patients (52.2%) had been readmitted at least once, 132 (24.1%) for CHF. Patients readmitted for CHF had an increased risk for death (p < 0.0001) and cardiac death (p < 0.0001) compared with those not readmitted for CHF. On multivariate analysis, aortic mean gradient (hazard ratio [HR]: 0.88; 95% confidence interval [CI]: 0.79 to 0.99; p = 0.03), post-procedural blood transfusion (HR: 2.27; 95% CI: 1.13 to 5.56; p = 0.009), severe post-procedural pulmonary hypertension (HR: 1.04; 95% CI: 1.00 to 1.07; p < 0.0001), and left atrial diameter (HR: 1.47; 95% CI: 1.08 to 2.01; p = 0.02) were independently associated with CHF readmission at 1 year.

Conclusions: Readmission for CHF after TAVR was frequent and was strongly associated with 1-year mortality. Low gradient, persistent pulmonary hypertension, left atrial dilatation, and transfusions were predictive of readmission for CHF.
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http://dx.doi.org/10.1016/j.jcin.2017.09.010DOI Listing
December 2017

Outcomes in HeartMate II Patients With No Antiplatelet Therapy: 2-Year Results From the European TRACE Study.

Ann Thorac Surg 2017 Apr 13;103(4):1262-1268. Epub 2016 Oct 13.

Department of Cardiac, Thoracic, Transplantation and Vascular Surgery, Hannover Medical School, Hannover, Germany.

Background: Current recommendations of antithrombotic therapy for HeartMate II (HMII) patients include the use of both an anticoagulant and an antiplatelet agent. Because bleeding is still the most frequent adverse event, the TRACE (STudy of Reduced Anti-Coagulation/Anti-platelet Therapy in Patients with the HeartMatE II) study was initiated to evaluate the incidence of adverse events in HMII patients on reduced antithrombotic (RT) therapy.

Methods: HMII patients (n = 101) from nine centers were enrolled in the European arm of TRACE and were managed on a single anticoagulant (vitamin K antagonist) with no antiplatelet agents. An analysis of bleeding and thrombotic adverse events from all 101 patients with 2-year follow-up after initiation of RT therapy is reported here.

Results: Median age was 56 years (range, 18 to 72 years), 93% were men, 70% had an Interagency Registry for Mechanically Assisted Circulatory Support profile 1 to 3, and 82% received the HMII as a bridge to transplantation. Ninety-two percent were placed on RT therapy as a center standard of care or due to physician preference and 6% as a response to bleeding. Median HMII support duration on RT therapy was 25 months (range, 1 to 93 months). Median international normalized ratio was 2.31 [quartile 1 to quartile 3: 2.07 to 2.60]. At 2 years, freedom from bleeding, ischemic stroke, hemorrhagic stroke, and pump thrombosis after initiation of RT therapy was 81% ± 6%, 96% ± 2%, 94% ± 3%, and 94% ± 3%, respectively.

Conclusions: The 2-year analysis of the observational European TRACE study suggests that managing HMII patients with a vitamin K antagonist with a target international normalized ratio of 2.3 without antiplatelet therapy may help to reduce the incidence of major bleeding without increasing the risk of thromboembolic events, including ischemic stroke and pump thrombosis.
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http://dx.doi.org/10.1016/j.athoracsur.2016.07.072DOI Listing
April 2017

Trends over the past 4 years in population characteristics, 30-day outcomes and 1-year survival in patients treated with transcatheter aortic valve implantation.

Arch Cardiovasc Dis 2016 Aug-Sep;109(8-9):457-64. Epub 2016 Jun 21.

Centre Hospitalier Universitaire Charles-Nicolle, Université de Rouen, Inserm U1096, Rouen, France.

Background: Transcatheter aortic valve implantation (TAVI) is recommended in patients with severe aortic stenosis that is either inoperable or at high-risk for surgical valve replacement.

Aims: To evaluate trends in the feasibility and safety of transfemoral TAVI over the past 4 years.

Methods: Between 2010 and 2013, all consecutive patients undergoing TAVI in our institution were included in a prospective registry. Population characteristics and 30-day and 1-year outcomes were analysed. Outcomes were classified according to the Valve Academic Research Consortium-2.

Results: Overall, 429 patients underwent TAVI; transfemoral access was used in 368 (85.7%). The proportion of patients treated via a transfemoral approach increased (70.1% to 89.9%; P<0.0001) and the use of prior balloon aortic valvuloplasty decreased (44.7% to 11.2%; P<0.0001). The mean logistic EuroSCORE decreased significantly from 19.4±10.9% to 15.8±8.7% (P=0.01). The 30-day mortality rate did not change significantly (6.4% vs. 5.6%; P=0.99). Similarly, rates of major vascular complications (12.8% vs. 15.4%; P=0.87) and stroke (2.1% vs. 1.4%; P=0.75) remained unchanged. Mean length of stay after TAVI decreased significantly from 8.9±11.3 days to 4.8±4.7 days (P=0.002) and 72 (50.3%) patients were discharged early in 2013. One-year survival increased significantly from 81.0% to 94.4% (P=0.03).

Conclusions: Over the past 4 years, TAVI has been increasingly performed using a transfemoral approach. Treated patients are at lower-risk with less co-morbidity. Thirty-day mortality and complications remained unchanged, but length of stay after TAVI and 1-year mortality decreased dramatically.
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http://dx.doi.org/10.1016/j.acvd.2016.01.016DOI Listing
January 2017

Role of inflammatory cells and adenosine in lung ischemia reoxygenation injury using a model of lung donation after cardiac death.

Exp Lung Res 2016 Apr;42(3):131-41

a Department of Thoracic and Cardio-Vascular Surgery , University Hospital of Rouen , Rouen , France.

Aim: The objective of this study is to analyze the role of inflammation in the lung ischemia reperfusion (IR) injury and determine the protective role of adenosine in an in vitro lung transplantation model.

Materials And Methods: We used a hybrid model of lung donor after cardiac death, with warm ischemia in corpo of varying duration (2 h, 4 h) followed by in vitro lung slices culture for reoxygenation (1 h, 4 h and 24 h), in the presence or not of lymphocytes and of adenosine. To quantify the inflammatory lesions, we performed TNFα, IL2 assays, and histological analysis.

Results: In this model of a nonblood perfused system, the addition of lymphocytes during reoxygenation lead to higher rates of TNFα and IL2 after 4 h than after 2 h of warm ischemia (P < .05). These levels increased with the duration of reoxygenation and were maximum at 24 h (P < .05). In the presence of adenosine TNFα and IL2 decreased. After 2 h of warm ischemia, we observed a significant inflammatory infiltration, alveolar thickening and a necrosis of the bronchiolar cells. After 4 h of warm ischemia, alveolar cells necrosis was associated.

Conclusion: This model showed that lymphocytes increased the inflammatory response and the histological lesions after 4 h of warm ischemia and that adenosine could have an anti-inflammatory role with potential reconditioning action when used in the pneumoplegia solution.
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http://dx.doi.org/10.3109/01902148.2016.1158887DOI Listing
April 2016

Organotypic lung culture: A new model for studying ischemia and ex vivo perfusion in lung transplantation.

Exp Lung Res 2015 ;41(10):564-75

b Inserm U1096, Rouen University , France.

Aim: Donors after cardiac death (DCD) in lung transplantation is considered as a solution for organ shortage. However, it is characterized by warm ischemic period, which could be involved in severe Ischemia-Reperfusion lesion (IR) with early graft dysfunction. We describe a new hybrid model combining in vivo ischemia followed by in vitro reoxygenation using organ-specific culture.

Material And Methods: A hybrid model using in vivo ischemic period followed by in vitro lung slice reoxygenation was set up in rat to mimic DCD in lung transplantation with in vitro perfusion. Different markers (bioenergetics, oxidant stress assays, and histology) were measured to evaluate the viability of lung tissue after different ischemic times (I-0, I-1, I-2, I-4, I-15 hours) and reoxygenation times (R-0, R-1, R-4, R-24 hours).

Results: No differences were found in cell viability, ATP concentrations, extracellular LDH assays or histology, demonstrating extensive viability of up to 4 hours in lung tissue warm ischemia. We found oxidative stress mainly during the ischemic period with no burst at reoxygenation. Cytosolic anti-oxidant system was involved first (I-0,I-1,I-2) followed by mitochondrial anti-oxidant system for extensive ischemia (I-4). Histological features showed differences in this model of ischemia-reoxygenation between bronchial epithelium and lung parenchymal cells, with epithelium regeneration after 2 hours of warm ischemia and 24 hours of perfusion.

Conclusion: The results of our hybrid model experiment suggest extensive lung viability of up to 4 hours ischemia. Our model could be an interesting tool to evaluate ex vivo reconditioning techniques after different in vivo lung insults.
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http://dx.doi.org/10.3109/01902148.2015.1123328DOI Listing
September 2016

Surgical resection of circumferential epicardial adipose tissue hypertrophy: Case report and systematic review of the literature.

J Thorac Cardiovasc Surg 2016 Feb 26;151(2):e27-30. Epub 2015 Sep 26.

Department of Thoracic and Cardiovascular Surgery, Rouen University Hospital Charles Nicolle, Rouen, France.

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http://dx.doi.org/10.1016/j.jtcvs.2015.08.083DOI Listing
February 2016

A difficult decision: what should we do when malignant tumours are diagnosed in patients supported by left ventricular assist devices?

Eur J Cardiothorac Surg 2015 Sep 18;48(3):e30-6. Epub 2015 Jun 18.

Department of Thoracic and Cardiovascular Surgery, Rouen University Hospital Charles Nicolle, Rouen, France Department of Urology, Andrology and Renal Transplantation, Rouen University Hospital Charles Nicolle, Rouen, France Department of General and Thoracic Surgery, Rouen University Hospital Charles Nicolle, Rouen, France Unit of Vascular Haemostasis, Rouen University Hospital Charles Nicolle, Rouen, France INSERM U1096, Rouen University Hospital, Rouen, France.

Objectives: Left ventricular assist devices (LVADs) are used as a bridge to heart transplantation. During the preimplantation or pretransplantation screening, malignant tumours can be discovered. Owing to the lack of guidelines, the management is difficult. We describe our perioperative approach and the patients' outcomes.

Methods: Between 2006 and 2014, 55 patients underwent implantation of HeartMate II LVAD. Five were diagnosed with malignant tumours: 2 renal, 2 lung and 1 breast tumours. The renal tumours were diagnosed during the preimplantation screening. An LVAD was implanted in both followed by partial nephrectomies 8 and 9 months later. The lung cancers were diagnosed after device implantation, a left pulmonary segmentectomy and a right upper sleeve lobectomy were performed. The breast cancer was diagnosed few months after support and a tumourectomy with lymphadenectomy was performed.

Results: Tumour resection was performed successfully in all patients. Prior to surgery haemostasis, device and heart function were evaluated. During surgery, haemodynamics and anticoagulation were monitored. Reoperations were necessary to evacuate haemothorax after lobectomy and an abdominal haematoma post-nephrectomy. After discussion with oncologists, 3 patients were relisted for heart transplantation. Two were successfully transplanted 2 and 3 years after partial nephrectomy with an actual survival of 56 and 59 months after the cancer diagnosis. The follow-up revealed no cancer recurrences.

Conclusions: Malignant tumours during support with LVAD can be successfully resected. A multidisciplinary evaluation in these high-risk patients is mandatory. After careful evaluation, regaining the patient's heart transplant candidacy is possible.
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http://dx.doi.org/10.1093/ejcts/ezv203DOI Listing
September 2015

Feasibility and safety of early discharge after transfemoral transcatheter aortic valve implantation with the Edwards SAPIEN-XT prosthesis.

Am J Cardiol 2015 Apr 31;115(8):1116-22. Epub 2015 Jan 31.

Department of Cardiology, Hospital Charles Nicolle, University Hospital of Rouen, Rouen, France.

There is currently no consensus on the duration of hospitalization required after transfemoral transcatheter aortic valve implantation (TAVI). We report the feasibility and safety of early discharge after TAVI with the Edwards SAPIEN-XT prosthesis. From 2009 to 2013, 337 patients underwent transfemoral TAVI with the Edwards SAPIEN-XT prosthesis using local anesthesia and were discharged home either early (≤3 days, Early Discharge group, n = 121) or after 3 days (Late Discharge group, n = 216). The primary end point of the study combined death and rehospitalization from discharge to 30-day follow-up. Patients in the Early Discharge group were less symptomatic (New York Heart Association class ≥III: 64.5% vs 75.5%, p = 0.01) and had less renal failure (creatinine: 102.1 ± 41.0 vs 113.3 ± 58.9 μmol/L, p = 0.04), atrial fibrillation (33.1% vs 46.3%, p = 0.02), and previous balloon aortic valvuloplasty (11.6% vs 23.1%, p = 0.01) and were more likely to have a pacemaker before TAVI (16.5% vs 8.3%, p = 0.02). Pre-existing pacemaker (p = 0.05) and the absence of acute kidney injury (p = 0.02) were independent predictors of an early discharge, whereas previous balloon aortic valvuloplasty (p = 0.03) and post-TAVI blood transfusions (p = 0.002) were independent predictors of late discharge. The primary end point occurred in 4 patients (3.3%) in the Early Discharge group and in 11 patients (5.1%) in the Late Discharge group (p = 0.58). In conclusion, the results of our study suggest that early discharge after transfemoral TAVI using the Edwards SAPIEN-XT prosthesis is feasible and safe in selected patients.
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http://dx.doi.org/10.1016/j.amjcard.2015.01.546DOI Listing
April 2015

Comparison of two antiplatelet therapy strategies in patients undergoing transcatheter aortic valve implantation.

Am J Cardiol 2014 Jan 5;113(2):355-60. Epub 2013 Oct 5.

University Hospital of Rouen, Hospital Charles Nicolle, Departments of Cardiology and Thoracic and Cardiovascular Surgery, INSERM UMR 1096, Rouen, France.

Dual antiplatelet therapy is commonly used in patients undergoing transcatheter aortic valve implantation (TAVI), but the optimal antiplatelet regimen is uncertain and remains to be determined. The objective of this study was to compare 2 strategies of antiplatelet therapy in patients undergoing TAVI. A strategy using monoantiplatelet therapy (group A, n = 164) was prospectively compared with a strategy using dual antiplatelet therapy (group B, n = 128) in 292 consecutive patients undergoing TAVI. The primary end point was a combination of mortality, major stroke, life-threatening bleeding (LTB), myocardial infarction, and major vascular complications at 30 days. All adverse events were adjudicated according to the Valve Academic Research Consortium. The primary end point occurred in 22 patients (13.4%) in the group A and in 30 patients (23.4%) in the group B (hazard ratio 0.51, 95% confidence interval 0.28 to 0.94, p = 0.026). LTB (3.7% vs 12.5%, p = 0.005) and major bleedings (2.4% vs 13.3%, p <0.0001) occurred less frequently in the group A, whereas the incidence of stroke (1.2% vs 4.7%, p = 0.14) and myocardial infarction (1.2% vs 0.8%, p = 1.0) was not significantly different between the 2 groups. The benefit of a strategy using mono versus dual antiplatelet therapy persisted after multivariate adjustment and propensity score analysis (hazard ratio 0.53, 95% confidence interval 0.28 to 0.95, p = 0.033). In conclusion, a strategy using mono versus dual antiplatelet therapy in patients undergoing TAVI reduces LTB and major bleedings without increasing the risk of stroke and myocardial infarction. The results of our study question the justification of dual antiplatelet therapy and require confirmation in a randomized trial.
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http://dx.doi.org/10.1016/j.amjcard.2013.09.033DOI Listing
January 2014

Is anti-platelet therapy needed in continuous flow left ventricular assist device patients? A single-centre experience.

Eur J Cardiothorac Surg 2014 Jan 12;45(1):55-9; discussion 59-60. Epub 2013 May 12.

Department of Thoracic and Cardiovascular Surgery, Rouen University Hospital Charles Nicolle, Rouen, France.

Objectives: We report our 5-year experience of continuous flow left ventricular assist device (LVAD) implantation without the use of anti-platelet therapy.

Methods: Between February 2006 and September 2011, 27 patients (26 men; 1 woman) were implanted with a continuous flow LVAD (HeartMate II, Thoratec Corporation, Pleasanton, CA, USA). The mean age was 55.7 ± 9.9 years. The mean duration of support was 479 ± 436 (1-1555) days with 35.4 patient-years on support. Twenty-one patients were implanted as a bridge to transplantation and 6 for destination therapy. The anticoagulation regimen was fluindione for all patients, with aspirin for only 4 patients. At the beginning of our experience, aspirin was administered to 4 patients for 6, 15, 60 and 460 days. Due to gastrointestinal (GI) bleeding and epistaxis, aspirin was discontinued, and since August 2006, no patients have received anti-platelet therapy.

Results: At 3 years, the survival rate during support was 76%. The most common postoperative adverse event was GI bleeding (19%) and epistaxis (30%) (median time: 26 days) for patients receiving fluindione and aspirin. The mean International Normalized Ratio (INR) was 2.58 ± 0.74 during support. Fifteen patients have been tested for acquired Von Willebrand disease. A diminished ratio of collagen-binding capacity and ristocetin cofactor activity to Von Willebrand factor antigen was observed in 7 patients. In the postoperative period, 2 patients presented with ischaemic stroke at 1 and 8 months. One of these 2 patients had a previous history of carotid stenosis with ischaemic stroke. There were no patients with haemorrhagic stroke, transient ischaemic attack or pump thrombosis. The event rate of stroke (ischaemic and haemorrhagic) per patient-year was 0.059 among the patients without aspirin with fluindione regimen only.

Conclusions: A fluindione regimen without aspirin in long-duration LVAD support appears to not increase thromboembolic events and could lead to a diminished risk of haemorrhagic stroke.
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http://dx.doi.org/10.1093/ejcts/ezt228DOI Listing
January 2014

Performance analysis of EuroSCORE II compared to the original logistic EuroSCORE and STS scores for predicting 30-day mortality after transcatheter aortic valve replacement.

Am J Cardiol 2013 Mar 18;111(6):891-7. Epub 2013 Jan 18.

Department of Cardiology, University Hospital of Rouen, Hospital Charles Nicolle, INSERM UMR 1096, Rouen, France.

The original European System for Cardiac Operative Risk Evaluation (EuroSCORE) has been recently updated as EuroSCORE II to optimize its efficacy in cardiac surgery, but its performance has been poorly evaluated for predicting 30-day mortality in patients who undergo transcatheter aortic valve replacement (TAVR). Consecutive patients (n = 250) treated with TAVR were included in this analysis. Transapical access was used in 60 patients, while 190 procedures were performed using a transfemoral approach. Calibration (risk-adjusted mortality ratio) and discrimination (C-statistic and U-statistic) were calculated for the logistic EuroSCORE, EuroSCORE II, and Society of Thoracic Surgeons (STS) scores for predicting 30-day mortality. Observed mortality was 7.6% in the overall population (6.3% and 11.7% for the transfemoral and transapical cohorts, respectively). Predicted mortality was 22.6 ± 12.8% by logistic EuroSCORE, 7.7 ± 5.8% by EuroSCORE II, and 7.3 ± 4.1% by STS score. The risk-adjusted mortality ratio was 0.34 (95% confidence interval [CI] 0.10 to 0.58) for logistic EuroSCORE, 0.99 (95% CI 0.29 to 1.69) for EuroSCORE II, and 1.05 (95% CI 0.30 to 1.79) for STS score. Moderate discrimination was observed with EuroSCORE II (C-index 0.66, 95% CI 0.52 to 0.79, p = 0.02) compared to the logistic EuroSCORE (C-index 0.63, 95% CI 0.51 to 0.76, p = 0.06) and STS (C-index 0.58, 95% CI 0.43 to 0.73, p = 0.23) score, without a significant difference among the 3 risk scores. Discrimination was slightly better in the transfemoral cohort compared to the transapical cohort with the 3 risk scores. In conclusion, EuroSCORE II and the STS score are better calibrated than the logistic EuroSCORE but have moderate discrimination for predicting 30-day mortality after TAVR.
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http://dx.doi.org/10.1016/j.amjcard.2012.11.056DOI Listing
March 2013

Incidence, predictors and impact of bleeding after transcatheter aortic valve implantation using the balloon-expandable Edwards prosthesis.

Heart 2013 Jun 12;99(12):860-5. Epub 2012 Dec 12.

Department of Cardiology, Charles Nicolle University Hospital, INSERM U 1096, 1 rue de Germont, Rouen Cedex 76031, France.

Objectives: To evaluate the incidence, predictors and impact of bleeding after transcatheter aortic valve implantation (TAVI).

Design: Single-centre prospective observational study.

Setting: Charles Nicolle University Hospital, Rouen, France.

Interventions: We included 250 consecutive patients who underwent TAVI between May 2006 and October 2011. All procedures were performed using Edwards SAPIEN and SAPIEN XT valves via transfemoral (TF) and transapical (TA) routes. Surgical cutdown was used for TF access when implanting the SAPIEN valve, while percutaneous access was used for SAPIEN XT implantation. Life-threatening bleeding (LTB), major and minor bleeding and other complications were defined using Valve Academic Research Consortium criteria.

Results: TAVI was performed via TF access in 190 cases (76%) and the SAPIEN XT valve was used in 123 cases (49.2%). Bleeding after TAVI was noted in 68 patients (27.2%): LTB in 33 (13.2%), major bleeding in 23 (9.2%) and minor bleeding in 12 (4.8%). By multivariate analysis, only TA access was an independent predictor of LTB (OR 3.7, 95% CI 1.73 to 7.9, p = 0.001). Patients presenting with LTB after TAVI had a higher 30-day mortality (33.3% vs 3.7%, p < 0.001) and 1-year mortality (54% vs 18%, p < 0.001). LTB was an independent predictive factor of 1-year mortality (HR 2.54, 95% CI 1.3 to 4.9, p = 0.002).

Conclusions: Bleeding is a frequent complication of TAVI, occurring in 27% of cases. LTB is associated with higher 30-day and 1-year mortality.
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http://dx.doi.org/10.1136/heartjnl-2012-303095DOI Listing
June 2013

Transfemoral aortic valve replacement with the Edwards SAPIEN and Edwards SAPIEN XT prosthesis using exclusively local anesthesia and fluoroscopic guidance: feasibility and 30-day outcomes.

JACC Cardiovasc Interv 2012 May 9;5(5):461-467. Epub 2012 May 9.

Department of Cardiology, University Hospital of Rouen, INSERM U 1096, Hospital Charles Nicolle, Rouen, France. Electronic address:

Objectives: The authors report the feasibility and 30-day outcomes of transfemoral aortic valve replacement (TAVR), using the Edwards SAPIEN (Edwards Lifesciences, Irvine, California) and Edwards SAPIEN XT (Edwards Lifesciences) prosthesis, implanted using exclusively local anesthesia and fluoroscopic guidance.

Background: Transfemoral TAVR is often managed with general anesthesia. However, a simplified percutaneous approach using local anesthesia has become more popular because it offers multiple advantages in an elderly and fragile population.

Methods: Between May 2006 and January 2011, the authors prospectively evaluated 151 consecutive patients (logistic EuroSCORE: 22.8 ± 11.8%) who underwent TAVR (SAPIEN: n = 78, SAPIEN XT: n = 73) using only local anesthesia and fluoroscopic guidance. The primary endpoint was a combination of all-cause mortality, major stroke, life-threatening bleeding, stage 3 acute kidney injury (AKI), periprocedural myocardial infarction (MI), major vascular complication, and repeat procedure for valve-related dysfunction at 30 days.

Results: Transarterial femoral approach was surgical in all SAPIEN procedures and percutaneous in 97.3% of SAPIEN XT, using the ProStar vascular closure device, and was well tolerated in all cases. Conversion to general anesthesia was required in 3.3% (SAPIEN cases) and was related to complications. Vasopressors were required in 5.5%. Procedural success was 95.4%. The combined-safety endpoint was reached in 15.9%, including overall mortality (6.6%), major stroke (2.0%), life-threatening bleeding (7.9%), stage 3 AKI (0.7%), periprocedural MI (1.3%), major vascular complication (7.9%), and repeat procedure for valve-related dysfunction (2.0%) at 30 days. A permanent pacemaker was required in 5.3%.

Conclusions: This single-center, prospective registry demonstrated the feasibility and safety of a simplified transfemoral TAVR performed using only local anesthesia and fluoroscopic guidance in high surgical risk patients with severe aortic stenosis.
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http://dx.doi.org/10.1016/j.jcin.2012.01.018DOI Listing
May 2012

[Selection of patients for transcatheter aortic valve implantation].

Presse Med 2012 Jun 24;41(6 Pt 1):628-33. Epub 2012 Apr 24.

Hôpital Charles-Nicolle, CHU de Rouen, service de cardiologie, 76000 Rouen, France.

A good selection of patients is a crucial step before transcatheter aortic valve implantation (TAVI) in order to select the good indications and choose the access route. TAVI should be considered only in patients with symptomatic severe aortic stenosis and either contraindication or high surgical risk. Indication for TAVI should be discussed in a multidisciplinary team meeting. Echocardiography and/or CT scan are mandatory to evaluate the aortic annulus size and select the good prosthesis size. The possibility of transfemoral implantation is evaluated by angiography and CT scan, and based on the arterial diameters, but also on the presence of tortuosities and arterial calcifications.
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http://dx.doi.org/10.1016/j.lpm.2012.03.009DOI Listing
June 2012

Transapical aortic valve implantation in Rouen: four years' experience with the Edwards transcatheter prosthesis.

Arch Cardiovasc Dis 2012 Mar 21;105(3):141-5. Epub 2012 Mar 21.

Department of Thoracic and Cardiovascular Surgery, Charles Nicolle University Hospital, Rouen, France.

Background: The first French transapical transcatheter aortic valve implantation (TAVI) was performed in July 2007 in our department.

Aims: To report 4-year outcomes of transapical implantation with the Edwards transcatheter bioprosthesis.

Methods: We prospectively evaluated consecutive patients who underwent transapical implantation with an Edwards transcatheter bioprosthesis between July 2007 and October 2011. Patients were not suitable for conventional surgery (due to severe comorbidities) or transfemoral implantation (due to poor femoral access).

Results: Among 61 patients (59.0% men), mean logistic EuroSCORE was 27.5 ± 14.9% and mean age was 81.0 ± 6.8 years. Successful valve implantation was achieved in 59/61 patients (96.7%) of patients. The other two patients required conversion to conventional surgery due to prosthesis embolization and died. Six additional patients died in the postoperative period. Causes of perioperative death were two septic shocks (one of peritonitis), two multi-organ failure, one ventricular fibrillation and one respiratory insufficiency. Intraprocedural stroke was not observed in any patient. The actuarial survival rates at 1, 2 and 4 years were 73.8%, 67.2% and 41.0%. During this 4-year period, four patients died of cardiovascular events, but no impairment of transprosthesis gradient was observed.

Conclusion: Our series of 61 patients who underwent transapical implantation of the Edwards transcatheter bioprosthesis shows satisfactory results, similar to other reports, considering the high level of severity of patients referred for this method. Transapical access is a reliable alternative method for patients that cannot benefit from a transfemoral approach.
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http://dx.doi.org/10.1016/j.acvd.2012.02.005DOI Listing
March 2012

Prospective analysis of 30-day safety and performance of transfemoral transcatheter aortic valve implantation with Edwards SAPIEN XT versus SAPIEN prostheses.

Arch Cardiovasc Dis 2012 Mar 16;105(3):132-40. Epub 2012 Mar 16.

Department of Cardiology, Hospital Charles-Nicolle, University Hospital of Rouen, Rouen cedex, France.

Background: A new generation of balloon-expandable valves (e.g. Edwards SAPIEN XT) enables the use of a decreased sheath size using the NovaFlex™ delivery system for transfemoral transcatheter aortic valve implantation (TAVI). However, there are few data analysing the efficacy and safety of this new prosthesis.

Aims: To evaluate periprocedural and 30-day clinical outcomes using the Edwards SAPIEN XT compared with the first-generation Edwards SAPIEN prosthesis.

Methods: Between May 2006 and October 2011, consecutive high-risk or non-operable patients with severe aortic stenosis had TAVI using an Edwards SAPIEN or SAPIEN XT prosthesis. Valve Academic Research Consortium endpoints were used.

Results: Of 250 patients who underwent TAVI, 190 were performed transfemorally (78 SAPIEN and 112 SAPIEN XT). Transfemoral access was possible more often using SAPIEN XT (112/123 [91.1%] vs 78/127 [61.4%]; P<0.001). Mean logistic EuroSCORE was significantly lower in the SAPIEN XT group (18.1±11.0% vs 27.3±11.1%; P<0.0001), and the iliofemoral artery minimal lumen diameter was smaller (6.7±1.2 vs 8.5±1.3mm; P<0.0001). Device success was similar in both groups (95.5% for SAPIEN XT and 93.6% for SAPIEN), as was the 30-day combined safety endpoint (15.2% and 17.9%, respectively). At 30days, prosthesis performance was similar in both groups.

Conclusions: Short-term safety and performance analysis of the latest generation of balloon-expandable valve, the SAPIEN XT, seem similar to the previous generation. However, transfemoral implantation is more often possible, related to sheath size reduction.
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http://dx.doi.org/10.1016/j.acvd.2012.02.002DOI Listing
March 2012

Survival after biventricular mechanical circulatory support: does the type of device matter?

J Heart Lung Transplant 2012 May 13;31(5):501-8. Epub 2012 Jan 13.

Department of Heart Surgery at Institut de Cardiologie, Hôpital La Pitié-Salpétrière, Paris, France.

Background: Biventricular support can be achieved using paracorporeal biventricular assist devices (BiVADs), the total artificial heart (TAH), and implantable VADs. This study evaluated the influence of the device on patient survival.

Methods: Data from 383 patients (321 men [84%]) undergoing primary, planned biventricular support using durable devices between 2000 and 2010 were extracted from the French multicentric Groupe de Réflexion sur l'Assistance Mécanique (GRAM) registry. Mean age was 41.6 ± 14.0 years. Patients were classified as group 1, 255 (67%) with paracorporeal BiVADs; group 2, 90 (24%) with TAH; and group 3, 38 (10%) with implantable BiVADs.

Results: Mean patient support duration was 82.8 ± 107.4 days and similar among groups (p = 0.53). Bridging to transplantation was successful in 211 patients (55%) and to recovery in 23 (6%). Mortality on device was similar among groups (p = 0.16). TAH patients had a significantly lower stroke rate (p < 0.0001). Actuarial estimates for survival while on support were 75.2% ± 2.3%, 64.4% ± 2.7%, 61.1% ± 2.8%, and 56.8% ± 3.1% at 30, 60, 90, and 180 days, respectively, and were similar among groups. However, TAH patients undergoing prolonged support (≥90 days) showed a trend toward improved survival (p = 0.08). Actuarial post-transplant survival estimates were, respectively, 81.7 ± 2.7, 75.3 ± 3.0, 73.0 ± 3.0, and 64.7 ± 3.7 at 1 month and 1, 3, and 5 years and were similar among groups (p = 0.84).

Conclusion: Survival while on support and after heart transplantation did not differ significantly in patients supported with paracorporeal BiVADs, implantable BiVADs, or the TAH. Patients undergoing prolonged support (>90 days) tended to have improved survival when supported with TAH compared with BiVADs, which may be related to a lower incidence of neurologic events.
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http://dx.doi.org/10.1016/j.healun.2011.11.024DOI Listing
May 2012

Evaluation of multislice computed tomography early after transcatheter aortic valve implantation with the Edwards SAPIEN bioprosthesis.

Am J Cardiol 2011 Sep 7;108(6):873-81. Epub 2011 Jul 7.

Department of Radiology, Rouen University Hospital, Rouen, France.

Currently, imaging assessment of patients who undergo transcatheter aortic valve implantation is based mainly on echocardiography and angiography, both limited to provide a 3-dimensional evaluation of the prosthesis within the native valve. This study involved 34 patients who underwent multislice computed tomography (MSCT) after transcatheter aortic valve implantation. Prosthesis expansion and circularity, depth of implantation, apposition degree at the ventriculoaortic junction, and positioning in relation to coronary artery ostia were evaluated. Early clinical events such as aortic regurgitation and periprocedural conduction abnormalities were recorded and correlated with multislice computed tomographic findings. MSCT provided comprehensive 3-dimensional assessments of the prostheses in 31 of 34 of patients (91%). Expansion was excellent (mean expansion ratio 100.0 ± 10.4%) and increased significantly from the ventricular side to the aortic side of the prosthesis. Circular deployment was achieved in most patients and increased from the ventricular to the aortic side. Mean implantation depth was -2.4 ± 2.5 mm, associated with a low rate (12%) of permanent pacemaker implantation. Patients with a new conduction abnormalities had the deepest prosthesis implantation, associated with lesser expansion and circularity. Perfect apposition on MSCT was associated with a low rate of significant aortic regurgitation. In conclusion, MSCT is able to provide an accurate 3-dimensional evaluation of prosthesis deployment and positioning after transcatheter aortic valve implantation. Moreover, these anatomic findings correlate with the most frequent early complications (i.e., the occurrence of aortic regurgitation and conduction abnormalities).
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http://dx.doi.org/10.1016/j.amjcard.2011.05.014DOI Listing
September 2011