Pierre-Yves Litzler

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

OBJECTIVESnThe 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.nnnBACKGROUNDnTransfemoral 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.nnnMETHODSnBetween 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.nnnRESULTSnTransarterial 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%.nnnCONCLUSIONSnThis 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.

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

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.

Performance Analysis of EuroSCORE II Compared to the Original Logistic EuroSCORE and STS Scores for Predicting 30-Day Mortality After Transcatheter Aortic Valve Replacement

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.

Comparison of Two Antiplatelet Therapy Strategies in Patients Undergoing Transcatheter Aortic Valve Implantation

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.

Technique of Transcatheter Aortic Valve Implantation with the Edwards-Sapien® Heart Valve Using the Transfemoral Approach

Transcatheter aortic valve implantation (TAVI) using a balloon-expandable valve has been developed by the authors’ group 7 years ago to offer a therapeutic solution to nonoperable or surgical high-risk patients with degenerative aortic stenosis. The technique and the devices used have rapidly evolved thereafter and TAVI has become a clinical reality with more than 3,500 patients implanted worldwide with this device. The currently used Edwards-Sapien® Transcatheter Heart Valve (THV) consists of a balloon-expandable stent with an integrated bovine pericardial valve. It can be implanted within the diseased native aortic valve using either the retrograde transfemoral or antegrade transapical routes.This article is aimed at describing the updated transfemoral technique. Appropriate patient selection is crucial for a successful procedure including close evaluation of the arterial characteristics. After predilatation of the native valve with a balloon catheter, the THV with its delivery system is introduced within the femoral artery, advanced to the native aortic valve under X-ray control, positioned across the aortic annulus, and delivered by balloon inflation under rapid heart pacing. The acute procedural success is 96% and the technique leads to an immediate and lasting improvement of hemodynamics and clinical status. Complications are rare and the mortality rate is 6.3% at 1 month in this cohort of very sick patients. Procedural complications are headed by vascular injury related to the large size of the arterial introducers. An upcoming lower- profile Edwards THV should improve this issue and increase the indication for this less invasive approach in the near future. At the present time, the indications should be restricted to nonoperable or surgical highrisk patients and the procedure performed by experienced and formally trained physicians working in an optimal multidisciplinary environment.ZusammenfassungDie Transkatheter-Aortenklappenimplantation (TAVI) unter Verwendung einer ballonexpandierbaren Klappe wurde vor 7 Jahren von den Autoren entwickelt, um inoperablen oder chirurgischen Hochrisikopatienten mit degenerativer Aortenstenose eine therapeutische Lösung anzubieten. Die Technik und die verwendeten Devices haben sich danach schnell weiterentwickelt, und die TAVI ist mit weltweit mehr als 3 500 behandelten Patienten klinische Realität geworden. Die derzeit verwendeteEdwards-Sapien®-Transkatheter-Herzklappe (THV) besteht aus einem ballonexpandierbaren Stent mit einer integrierten biologischen (Rinderperikard) Herzklappenprothese. Sie kann über den retrograden transfemoralen oder den antegraden transapikalen Weg in die kranke native Aortenklappe eingepflanzt werden. Dieser Artikel beschreibt die modernisierte transfemorale Technik. Für eine erfolgreiche Durchführung ist eine entsprechende Patientenauswahl einschließlich genauer Evaluation der Arterieneigenschaften entscheidend. Nach Prädilatation der nativen Klappe mit einem Ballonkatheter wird die THV mit ihrem Zuführungssystem in die Schenkelarterie eingeführt, unter Röntgenkontrolle zur nativen Aortenklappe vorgeschoben, über dem Aortenbogen in Position gebracht und durch Aufdehnung des Ballons unter schneller Stimulation eingesetzt. Die akute technische Erfolgsrate liegt bei 96%, und die Technik führt zu einer sofortigen und dauerhaften Verbesserung der Hämodynamik und des klinischen Status. Komplikationen sind selten, und die Sterbeziffer liegt in dieser Kohorte schwerkranker Patienten nach 1 Monat bei 6,3%. An der Spitze der Verfahrenskomplikationen stehen Gefäßverletzungen im Zusammenhang mit der Größe der arteriellen Schleuse. Eine demnächst verfügbare Niedrigprofil- Edwards-THV sollte diesbezüglich zu einer Besserung führen und die Indikationen für diesen weniger invasiven Zugang in naher Zukunft erweitern. Gegenwärtig sollten die Indikationen auf inoperable oder chirurgische Hochrisikopatienten beschränkt und das Verfahren nur von erfahrenen und speziell geschulten Ärzten in einem optimalen multidisziplinären Umfeld durchgeführt werden.

Evaluation of Multislice Computed Tomography Early After Transcatheter Aortic Valve Implantation With the Edwards SAPIEN Bioprosthesis

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).

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

OBJECTIVESnThe 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).nnnBACKGROUNDnTAVR 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.nnnMETHODSnAll 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.nnnRESULTSnThis 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 (pxa0< 0.0001) and cardiacxa0death (pxa0< 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; pxa0= 0.03), post-procedural blood transfusion (HR:xa02.27; 95% CI: 1.13 to 5.56; pxa0= 0.009), severe post-procedural pulmonary hypertension (HR: 1.04; 95% CI: 1.00 to 1.07; pxa0< 0.0001), and left atrial diameter (HR: 1.47; 95% CI: 1.08 to 2.01; pxa0= 0.02) were independently associated withxa0CHF readmission at 1 year.nnnCONCLUSIONSnReadmission for CHF after TAVR was frequent and was strongly associated with 1-year mortality. Lowxa0gradient, persistent pulmonary hypertension, left atrial dilatation, and transfusions were predictive of readmission for CHF.

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

ABSTRACT 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.