TAVR Patients Requiring Anticoagulation: Direct Oral Anticoagulant or Vitamin K Antagonist?

OBJECTIVES: Using French transcatheter aortic valve replacement (TAVR) registries linked with the nationwide administrative databases, the study compared the rates of long-term mortality, bleeding, and ischemic events after TAVR in patients requiring oral anticoagulation with direct oral anticoagulants (DOACs) or vitamin K antagonists (VKAs). BACKGROUND: The choice of optimal drug for anticoagulation after TAVR remains debated. METHODS: Data from the France-TAVI and FRANCE-2 registries were linked to the French national health single-payer claims database, from 2010 to 2017. Propensity score matching was used to reduce treatment-selection bias. Two primary endpoints were death from any cause (efficacy) and major bleeding (safety). RESULTS: A total of 24,581 patients who underwent TAVR were included and 8,962 (36.4%) were treated with OAC. Among anticoagulated patients, 2,180 (24.3%) were on DOACs. After propensity matching, at 3 years, mortality (hazard ratio [HR]: 1.37; 95% confidence interval [CI]: 1.12-1.67; P < 0.005) and major bleeding including hemorrhagic stroke (HR: 1.64; 95% CI: 1.17-2.29; P < 0.005) were lower in patients on DOACs compared with those on VKAs. The rates of ischemic stroke (HR: 1.32; 95% CI: 0.81-2.15; P = 0.27) and acute coronary syndrome (HR: 1.17; 95% CI: 0.68-1.99; P = 0.57) did not differ among groups. CONCLUSIONS: In these large multicenter French TAVR registries with an exhaustive clinical follow-up, the long-term mortality and major bleeding were lower with DOACs than VKAs at discharge. The present study supports preferential use of DOACs rather than VKAs in patients requiring oral anticoagulation therapy after TAVR.

Idarucizumab (Praxbind®) for dabigatran reversal in patients undergoing heart transplantation: a cohort of ten patients.

BACKGROUND: Novel oral anticoagulants are used in atrial fibrillation. Idarucizumab has been approved for reversal of dabigatran in situations of life-threatening hemorrhage or emergency surgery. OBJECTIVES: We report a single center experience of ten patients on dabigatran therapy who were given idarucizumab prior to heart transplantation. METHODS & RESULTS: The mean plasma concentration of dabigatran prior to reversal was 139 ± 89 ng/ml. Hemoglobin, hematocrit and platelet levels were decreased after surgery. Surgical procedures were successfully performed with no increased risk, especially regarding bleeding complications. All patients were alive after 90 days. CONCLUSION: Dabigatran reversal with idarucizumab in contexts of emergency surgery/urgent procedures is an attractive and safe option to be taken into consideration for patients with end stage heart disease awaiting transplantation and indication of anticoagulant therapy.

Transcatheter aortic valve replacement performed with selective telemetry monitoring: A prospective study.

BACKGROUND: Telemetry monitoring (TM) with or without intensive care unit (ICU) admission is the standard of care after Transcatheter aortic valve replacement (TAVR). Regarding to improvements of the technique and procedural results, TM may be considered only in selected patients. We aimed to confirm feasibility and safety of selective TM in patients undergoing TAVR. METHODS: We prospectively evaluated 449 consecutive patients undergoing TAVR. Patients were transferred to general cardiology ward (GCW) without TM after the procedure when stable clinical state, transfemoral access, no baseline right bundle branch block (RBBB), left ventricular ejection fraction (LVEF) > 40%, and no complication including any electrocardiogram (ECG) change within 1 h after the procedure ("low-risk" group). Others patients were considered for TM in ICU ("high-risk" group). The primary endpoint evaluated in-hospital major adverse events after unit admission according to VARC-2 criteria. RESULTS: The mean age was 81.8 ± 7.5 years and mean EuroSCORE II was 7.5 ± 4.8%. In total, 116 patients (25.8%) were considered as "low-risk" patients and 163 patients (36.3%) were referred to GCW, including those with immediate pacemaker implantation. A total of 96 patients (21.3%) reached the primary endpoint including mainly conductive disorders (12.8%). No major adverse events, particularly no late severe conductive disorder, occurred in the "low-risk" group (negative predictive value of 100%). Baseline RBBB (p < 0.01), LVEF < 40% (p = 0.02) and "high-risk" group (p < 0.01) were predictive of outcomes. CONCLUSIONS: Using rigorous periprocedural selection criteria, patients' admission in GCW without TM can be routinely and safely performed in 1/3 of patients after TAVR.

Myocardial Injury After Balloon Predilatation Versus Direct Transcatheter Aortic Valve Replacement: Insights From the DIRECTAVI Trial.

Background Myocardial injury is associated with higher mortality after transcatheter aortic valve replacement (TAVR) and might be increased by prior balloon aortic valvuloplasty (BAV). We aimed to evaluate the impact of prior BAV versus direct prosthesis implantation on myocardial injury occurring after (TAVR) with balloon-expandable prostheses. Methods and Results The DIRECTAVI (Direct Transcatheter Aortic Valve Implantation) trial, an open-label randomized study, demonstrated noninferiority of TAVR without BAV (direct TAVR group) compared with systematic BAV (BAV group) with the Edwards SAPIEN 3 valve. High-sensitivity troponin was assessed before and the day after the procedure. Incidence of myocardial injury after the procedure (high-sensitivity troponin elevation >15× the upper reference limit [14 ng/L]) was the main end point. Impact of myocardial injury on 1-month adverse events (all-cause mortality, stroke, major bleeding, major vascular complications, transfusion, acute kidney injury, heart failure, pacemaker implantation, and aortic regurgitation) was evaluated. Preprocedure and postprocedure high-sensitivity troponin levels were available in 211 patients. The mean age of patients was 83 years (78-87 years), with 129 men (61.1%). Mean postprocedure high-sensitivity troponin was 124.9±81.4 ng/L in the direct TAVR group versus 170.4±127.7 ng/L in the BAV group (P=0.007). Myocardial injury occurred in 42 patients (19.9%), including 13 patients (12.2%) in the direct TAVR group and 29 (27.9%) in the BAV group (P=0.004). BAV increased by 2.8-fold (95% CI, 1.4-5.8) myocardial injury probability. Myocardial injury was associated with 1-month adverse events (P=0.03). Conclusions BAV increased the incidence and magnitude of myocardial injury after TAVR with new-generation balloon-expandable valves. Myocardial injury was associated with 1-month adverse events. These results argue in favor of direct SAPIEN 3 valve implantation. Registration URL: https://www.Clinicaltrials.gov; Unique identifier: NCT02729519.

Ruptured right Valsalva sinus into the right atrium due to infective endocarditis: a case report.

Rupture of Valsalva sinus remains a very rare and deadly complication of Valsalva sinus aneurysm with a high mortality rate. We report here the case of a 47-year-old man who presented to the emergency department with acute exercise-induced dyspnea, chest pain, and fever. Transthoracic (TTE) and transesophageal echocardiography (TEE) highlighted a rupture of the right Valsalva sinus in the right atrium due to infective endocarditis. After stabilization of the patient, a successful surgical repair with double pericardial patches was performed.

Prior Balloon Valvuloplasty Versus Direct Transcatheter Aortic Valve Replacement: Results From the DIRECTAVI Trial.

OBJECTIVES: The aim of this study was to evaluate device success of transcatheter aortic valve replacement (TAVR) using new-generation balloon-expandable prostheses with or without balloon aortic valvuloplasty (BAV). BACKGROUND: Randomized studies are lacking comparing TAVR without BAV against the conventional technique of TAVR with BAV. METHODS: DIRECTAVI (Direct Transcatheter Aortic Valve Implantation) was an open-label noninferiority study that randomized patients undergoing TAVR using the Edwards SAPIEN 3 valve with or without prior balloon valvuloplasty. The primary endpoint was the device success rate according to Valve Academic Research Consortium-2 criteria, which was evaluated using a 7% noninferiority margin. The secondary endpoint included procedural and 30-day adverse events. RESULTS: Device success was recorded for 184 of 236 included patients (78.0%). The rate of device success in the direct implantation group (n = 97 [80.2%]) was noninferior to that in the BAV group (n = 87 [75.7%]) (mean difference 4.5%; 95% confidence interval: -4.4% to 13.4%; p = 0.02 for noninferiority). No severe prosthesis-patient mismatch or severe aortic regurgitation occurred in any group. In the direct implantation group, 7 patients (5.8%) required BAV to cross the valve. Adverse events were related mainly to pacemaker implantation (20.9% in the BAV group vs. 19.0% in the direct implantation group; p = 0.70). No significant difference was found between the 2 strategies in duration of procedure, contrast volume, radiation exposure, or rate of post-dilatation. CONCLUSIONS: Direct TAVR without prior BAV was noninferior to the conventional strategy using BAV with new-generation balloon-expandable valves, but without procedural simplification. BAV was needed to cross the valve in a few patients, suggesting a need for upstream selection on the basis of patient anatomy. (TAVI Without Balloon Predilatation [of the Aortic Valve] SAPIEN 3 [DIRECTAVI]; NCT02729519).

Hemodynamic Performances and Clinical Outcomes in Patients Undergoing Valve-in-Valve Versus Native Transcatheter Aortic Valve Implantation.

Valve-in-valve (ViV) transcatheter aortic valve implantation (TAVI) emerged has a less invasive treatment than surgery for patients with degenerated bioprosthesis. However, few data are currently available regarding results of ViV versus TAVI in native aortic valve. We aimed to compare hemodynamic performances and 1-year outcomes between patients who underwent ViV procedure and patients who underwent non-ViV TAVI. This bicentric study included all patients who underwent aortic ViV procedure for surgical bioprosthetic aortic failure between 2013 and 2017. All patients who underwent TAVI were included in the analysis during the same period. ViV and non-ViV patients were matched with 1:2 ratio according to size, type of TAVI device, age (±5 years), sex, and STS score. Primary end point was hemodynamic performance including mean aortic gradient and aortic regurgitation at 1-year follow-up. A total of 132 patients were included, 49 in the ViV group and 83 in the non-ViV group. Mean age was 82.8 ± 5.9 years, 55.3% were female. Mean STS score was 5.2% ± 3.1%. Self-expandable valves were implanted in 78.8% of patients. At 1-year follow-up, aortic mean gradient was significantly higher in ViV group (18.1 ± 9.4 mm Hg vs 11.4 ± 5.4 mm Hg; p < 0.0001) and 17 (38.6%) patients had a mean aortic gradient ≥20 mm Hg vs 6 (7.8%) in the non-ViV group (p = 0.0001). Aortic regurgitation > grade 2 were similar in both groups (p = 0.71). In the ViV group, new pacemaker implantation was less frequent (p = 0.01) and coronary occlusions occurred only in ViV group (n = 2 [4.1%]). At 1-year follow-up, 3 patients (2.3%) died from cardiac cause, 1 (2.1%) in the ViV group vs 2 (2.4%) in the non-ViV group (p = 0.9). There was no stroke. In conclusion, compared with TAVI in native aortic stenosis, ViV appears as a safe and feasible strategy in patients with impaired bioprosthesis. As 1-year hemodynamic performances seem better in native TAVI procedure, long-term follow-up should be assessed to determinate the impact of residual stenosis on outcomes and durability.

Physician-Modified Thoracic Stent Grafts for the Arch After Surgical Treatment of Type A Dissection.

BACKGROUND: This study evaluated the outcome of physician-modified thoracic stent grafts for the treatment of dissecting aortic arch aneurysms after surgical treatment of acute type A dissection. METHODS: From August 2016 through February 2018, 13 patients (8 men and 5 women) underwent thoracic endovascular aortic repair in which physician-modified thoracic stent grafts were used to treat dissecting aortic arch aneurysms after surgical treatment of acute type A dissection. Patients were a mean age of 70.7 ± 10 years (range, 43 to 82 years). Four patients were treated in an emergent setting for a symptomatic aortic arch aneurysm. The aneurysmal disease involved zone 0 in 10 patients and zone 2 in 3. Seven patients (48%) were treated using an aortic arch stent graft with a single fenestration, combined with cervical debranching in 4 patients. Six patients underwent total endovascular aortic arch repair using a double-fenestrated stent graft. Additional planned endovascular procedures were performed in 3 patients. RESULTS: Median time for stent graft modifications was 18 minutes (range, 14 to 21 minutes). All the proximal entry tears in the arch were successfully excluded. The 30-day mortality rate was 0%. One patient (7.6%) had a stroke without permanent sequelae. The median length of stay was 5 days (range, 1 to 17 days). During follow up of 8 ± 6 months, there were no conversions to open repair, aortic rupture, paraplegia, or retrograde dissection. CONCLUSIONS: The use of physician-modified thoracic stent grafts for the treatment of dissecting aortic arch aneurysm after surgical treatment of acute type A dissection is feasible and effective. Durability concerns will need to be assessed in future studies.

Five-Year Clinical Outcome and Valve Durability After Transcatheter Aortic Valve Replacement in High-Risk Patients.

BACKGROUND: The FRANCE-2 registry (French Aortic National Corevalve and Edwards) previously reported good early- and medium-term clinical and echocardiographic efficacy for transcatheter aortic valve replacement. We here report 5-year follow-up results from the registry. METHODS: The registry includes all consecutive patients undergoing transcatheter aortic valve replacement for severe aortic stenosis in France. Follow-up is scheduled at 30 days, 6 months, then annually from 1 to 5 years. Clinical events were defined according to the Valve Academic Research Consortium criteria, and hemodynamic structural valve deterioration (SVD) was defined according to the consensus statement by the European Association of Percutaneous Cardiovascular Interventions. RESULTS: Between January 2010 and January 2012, 4201 patients were enrolled in 34 centers. Five-year vital status was available for 95.5% of patients; 88.1% had clinical evaluation or died. Overall, at 5 years, all-cause mortality was 60.8% (n=2478; 95% CI, 59.3% to 62.3%). The majority of cardiovascular events occurred in the first month after valve implantation, and incidence remained low thereafter, at <2% per year up to 5 years, except for heart failure. The rate of heart failure was 14.3% at 1 year, then decreased over time to <5% per year. In cumulative incidence function, the rates of severe SVD and moderate/severe SVD at 5 years were 2.5% and 13.3%, respectively. Mortality did not differ between patients with or without severe SVD (hazard ratio, 0.71; 95% CI, 0.47-1.07; P=0.1). Finally, in the population of patients with severe SVD, 1 patient (1.7%) experienced a stroke, and 8 patients presented ≥1 heart failure event (13.3%). CONCLUSIONS: The 5-year follow-up results of the FRANCE-2 registry represent the largest long-term data set available in a high-risk population. In surviving patients, the low rate of clinical events and the low level of SVD after 1 year support the long-term efficacy of transcatheter aortic valve replacement in both types of transcatheter prosthesis featuring in the registry.

Management of advanced heart failure: a review.

INTRODUCTION: Heart failure (HF) has become a global pandemic. Despite recent developments in both medical and device treatments, HF incidences continues to increase. The current definition of HF restricts itself to stages at which clinical symptoms are apparent. In advanced heart failure (AdHF), it is universally accepted that all patients are refractory to traditional therapies. As the number of HF patients increase, so does the need for additional treatments, with an increased proportion of patients requiring advanced therapies. Areas covered: This review discusses extensive evidence for the effect of medical treatment on HF, although the data on the effect on AdHF is scare. Authors review the relevant literature for treating AdHF patients. Furthermore, mechanical circulatory devices (MCD) have emerged as an alternative to heart transplantation and have been shown to enhance quality of life and reduce mortality therefore authors also review the current literature on the different MCD and technologies. Expert commentary: More patients will need advanced therapies, as the access to heart transplantation is limited by the number of available donors. AdHF patients should be identified timely since the window of opportunities for advanced therapy is narrow as their morbidity is progressive and survival is often short.

Reverse extra-anatomic aortic arch debranching procedure allowing thoracic endovascular aortic repair of a chronic ascending aortic aneurysm.

A 79-year-old woman was admitted with a large chronic dissecting ascending aortic aneurysm starting 5 mm distal to the ostia of the left coronary artery and ending immediately proximal to the innominate artery. A reverse extra-anatomic aortic arch debranching procedure was performed. During the same operative time, through a transapical approach, a thoracic stent graft was deployed with the proximal landing zone just distal to the coronary ostia and the distal landing zone excluding the origin of the left common carotid artery. The postoperative course was uneventful. Computed tomography at 12 months documented patent extra-anatomic aortic arch debranching and no evidence of endoleak.

Prognostic Impact of Calcium Score after Transcatheter Aortic Valve Implantation Performed With New Generation Prosthesis.

Calcium score (CS) is a well-known prognostic factor after transcatheter aortic valve implantation (TAVI) performed with first generation prosthesis but few data are available concerning new generation valves. The aim of this study was to evaluate if CS remains a prognostic factor after Sapien 3 and Evolut R valves implantation. Agatston CS was evaluated on multislice computed tomography before TAVI in 346 patients implanted with Sapien XT (n = 61), CoreValve (n = 57) devices, (group 1, n = 118), and with new generation Sapien 3 (n = 147), Evolut R (n = 81) prosthesis, (group 2, n = 228). Major adverse cardiovascular events and aortic regurgitation (AR) were evaluated at 1 month. The 2 groups were similar at baseline except for logistic Euroscore (20.1% in group 1 vs 15.0 % in group 2; p = 0.001), chronic renal failure (44.1% vs 37.2% respectively, p = 0.007) and preprocedural CS (4,092 ± 2,176 vs 3,682 ± 2,109 respectively, p = 0.022). In group 1, 28 patients (23.7%) had adverse clinical events vs 21 (9.2%) in group 2 (p <0.01). In multivariate analysis, a higher CS was predictive of adverse events in group 1 (5,785 ± 3,285 vs 3,565 ± 1,331 p <0.0001) but not in group 2 (p = 0.28). A higher CS was associated with AR in group 1 (6,234 ± 2711 vs 3,429 ± 1,505; p <0.001) and in patients implanted with an Evolut R device from group 2 (4,085 ± 3,645 vs 2,551 ± 1,356; p = 0.01). In conclusion, CS appears as an important prognostic factor of major events after TAVI with first generation valves but not with new generation devices. CS remains associated with AR only with new generation self-expandable Evolut R devices.

Experimental evaluation of homemade distal stent graft fenestration for thoracic endovascular aortic repair of type A dissection by a transapical approach.

OBJECTIVE: The use of off-the-shelf stent grafts for thoracic endovascular aortic repair of type A dissections is limited by variability in both the length of the ascending aorta and the location of the proximal intimal tear. This experimental study aimed to assess the feasibility of using a physician-modified thoracic aortic stent graft to treat acute type A dissection by a transapical cardiac approach. METHODS: The experiments were performed on six cadaveric human heart, ascending aorta, aortic arch, and descending aorta specimens. Fenestration was fashioned in each standard tubular Valiant thoracic stent graft (Valiant Captivia; Medtronic Vascular, Santa Rosa, Calif) to match the anatomy of each specimen. Stent grafts of sufficient length were selected to cover the entire ascending aorta and aortic arch. Stent graft diameters in proximal sealing zones were oversized by 5% to 10%. The length of the fenestration was the distance between the left subclavian artery and the proximal edge of the origin of the brachiocephalic trunk with an additional 10 mm. The diameter of the scallop was that of the brachiocephalic trunk with an additional 5 mm on all sides. The length of the covered portion of the stent graft was the distance between coronary arteries and the proximal edge of the origin of the brachiocephalic trunk. Two lateral radiopaque markers were positioned to delineate the distal and lateral edge of the scallop. Another 3-cm radiopaque marker was sutured onto the sheath to ensure accurate radiologic positioning of the scallop on the outer curve of the aorta. The left ventricle and the thoracic aorta were connected to a benchtop aortic pulsatile flow model. A 5-mm 30-degree lens was introduced through the left subclavian artery to monitor the procedure. The customized stent graft was deployed by a transapical approach under fluoroscopic control. RESULTS: Median duration of stent graft modification was 21 minutes (range, 17-40 minutes). All attempts to deploy the homemade proximal scalloped stent graft by a transapical approach were successful. Completion angiography demonstrated patency of the supra-aortic trunks and of the coronary arteries in all cases. Macroscopic evaluation did not identify any deterioration of the customized stent graft. CONCLUSIONS: The use of physician-modified stent grafts is feasible for thoracic endovascular aortic repair of type A dissection by a transapical approach in this model.

Effect of Impella During Veno-Arterial Extracorporeal Membrane Oxygenation on Pulmonary Artery Flow as Assessed by End-Tidal Carbon Dioxide.

Peripheral veno-arterial extracorporeal membrane oxygenation (VA ECMO) exposes the patient to a pulmonary blood flow bypass and a left ventricle afterload increase. Impella, a catheter-mounted microaxial rotary pump, has been proposed for left ventricle (LV) unloading in combination with VA ECMO. In order to assess the effect of Impella on pulmonary flow and LV preload, we checked Doppler pulmonary artery velocity-time integral (pVTI) and LV diastolic diameter (LVED) by transesophageal echocardiography and end-tidal carbon dioxide (EtCO2) during a step-by-step increase in Impella flow (Impella ramp test). From 134 patients on VA ECMO retrieved from our database, 27 (20%) have benefited secondary Impella implantation, out of which 11 patients had available EtCO2, pVTI, and LVED measurements at various levels of Impella speeds. We observed a proportional increases in pVTI and EtCO2 and decrease in LVED (p ≤ 0.001) during Impella flow increase. There was a significant correlation between EtCO2 and pVTI (Pearson correlation coefficient 0.64; p = 0.006). The study shows that Impella improves pulmonary flow, an effect that can be easily measured by EtCO2 monitoring, and ensures LV discharge, allowing adapting Impella flow adequately to patient's individual needs.

Circulatory Support with Extracorporeal Membrane Oxygenation and/or Impella for Cardiogenic Shock During Myocardial Infarction.

Temporary mechanical circulatory support (TCS) is recommended for patients with profound cardiogenic shock (CS). Extracorporeal membrane oxygenation (ECMO) and Impella are possible TCS devices, but the device choice and the implantation timing are not definitely established, specifically during acute myocardial infarction. We have analyzed the respective use of ECMO or Impella (2.5, CP, or 5.0) for CS following acute myocardial infarction, from a cohort of patients who underwent TCS within 72 hours after admission for emergency percutaneous coronary intervention (PCI) from January 2009 to April 2015. Among 88 TCS-treated patients, 42 had early TCS: 23 ECMO and 19 Impella. Cardiac management, including PCI, was similar between the two groups, but ECMO patients were sicker than Impella patients (higher blood lactate level at ICU admission, higher vasoactive-inotroic and ENCOURAGE scores before TCS implantation, p ≤ 0.02). Three patients (7%) have had TCS implantation before admission, but TCS was implanted mostly in cathlab (43%, 1 during PCI, 13 just after PCI) or soon after ICU admission (50%, n = 21). Modification of the initial TCS choice was required in 10 cases (24%) for assistance upgrading in case of Impella (n = 4) or for left ventricle unloading in case of ECMO (n = 6). Extracorporeal membrane oxygenation is the technique of choice in case of profound CS, whereas Impella devices seem more appropriate for less severe hemodynamic compromise. Interestingly, the combination of both techniques may help to overcome the limits inherent to each device.

Prior balloon valvuloplasty versus DIRECT transcatheter Aortic Valve Implantation (DIRECTAVI): study protocol for a randomized controlled trial.

BACKGROUND: Balloon predilatation of the aortic valve has been regarded as an essential step during the transcatheter aortic valve implantation (TAVI) procedure. However, recent evidence has suggested that aortic valvuloplasty may cause complications and that high success rates may be obtained without prior dilatation of the valve. We hypothesize that TAVI performed without predilatation of the aortic valve and using new-generation balloon-expandable transcatheter heart valves is associated with a better net clinical benefit than TAVI performed with predilatation. METHODS/DESIGN: The transcatheter aortic valve implantation without prior balloon dilatation (DIRECTAVI) trial is a randomized controlled open label trial that includes 240 patients randomized to TAVI performed with prior balloon valvuloplasty (control arm) or direct implantation of the valve (test arm). All patients with an indication for TAVI will be included excepting those requiring transapical access. The trial tests the hypothesis that the strategy of direct implantation of the new-generation balloon-expandable SAPIEN 3 valve is noninferior to current medical practice using predilatation of the valve. The primary endpoint assessing efficacy and safety of the procedure consists of immediate procedural success and secondary endpoints include complications at 30-day follow-up (VARC-2 criteria). A subgroup analysis evaluates neurological ischemic events with cerebral MRI imaging (25 patients in each strategy group) performed before and between 1 and 3 days after the procedure. DISCUSSION: This prospective randomized study is designed to assess the efficacy and safety of TAVI performed without prior dilatation of the aortic valve using new-generation balloon-expandable transcatheter heart valves. We aim to provide robust evidence of the advantages of this strategy to allow the interventional cardiologist to use it in everyday practice. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT02729519 . Registered on 15 July 2016.

Late Outcomes of Transcatheter Aortic Valve Replacement in High-Risk Patients: The FRANCE-2 Registry.

BACKGROUND: Transcatheter aortic valve replacement (TAVR) has revolutionized management of high-risk patients with severe aortic stenosis. However, survival and the incidence of severe complications have been assessed in relatively small populations and/or with limited follow-up. OBJECTIVES: This report details late clinical outcome and its determinants in the FRANCE-2 (FRench Aortic National CoreValve and Edwards) registry. METHODS: The FRANCE-2 registry prospectively included all TAVRs performed in France. Follow-up was scheduled at 30 days, at 6 months, and annually from 1 to 5 years. Standardized VARC (Valve Academic Research Consortium) outcome definitions were used. RESULTS: A total of 4,201 patients were enrolled between January 2010 and January 2012 in 34 centers. Approaches were transarterial (transfemoral 73%, transapical 18%, subclavian 6%, and transaortic or transcarotid 3%) or, in 18% of patients, transapical. Median follow-up was 3.8 years. Vital status was available for 97.2% of patients at 3 years. The 3-year all-cause mortality was 42.0% and cardiovascular mortality was 17.5%. In a multivariate model, predictors of 3-year all-cause mortality were male sex (p < 0.001), low body mass index, (p < 0.001), atrial fibrillation (p < 0.001), dialysis (p < 0.001), New York Heart Association functional class III or IV (p < 0.001), higher logistic EuroSCORE (p < 0.001), transapical or subclavian approach (p < 0.001 for both vs. transfemoral approach), need for permanent pacemaker implantation (p = 0.02), and post-implant periprosthetic aortic regurgitation grade ≥2 of 4 (p < 0.001). Severe events according to VARC criteria occurred mainly during the first month and subsequently in <2% of patients/year. Mean gradient, valve area, and residual aortic regurgitation were stable during follow-up. CONCLUSIONS: The FRANCE-2 registry represents the largest database available on late results of TAVR. Late mortality is largely related to noncardiac causes. Incidence rates of severe events are low after the first month. Valve performance remains stable over time.

Feasibility and Safety of Transcatheter Aortic Valve Implantation Performed Without Intensive Care Unit Admission.

Admission to the intensive care unit (ICU) is a standard of care after transcatheter aortic valve implantation (TAVI); however, the improvement of the procedure and the need to minimize the unnecessary use of medical resources call into question this strategy. We evaluated prospectively 177 consecutive patients who underwent TAVI. Low-risk patients, admitted to conventional cardiology units, had stable clinical state, transfemoral access, no right bundle branch block, permanent pacing with a self-expandable valve, and no complication occurring during the procedure. High-risk patients included all the others transferred to ICU. In-hospital events were the primary end point (Valve Academic Research Consortium 2 criteria). The mean age of patients was 83.5 ± 6.5 years, and the mean logistic EuroSCORE was 14.6 ± 9.7%. The balloon-expandable SAPIEN 3 valve was mainly used (n = 148; 83.6%), mostly with transfemoral access (n = 167; 94.4%). Among the 61 patients (34.5%) included in the low-risk group, only 1 (1.6%) had a minor complication (negative predictive value 98.4%, 95% confidence interval [CI] 0.91 to 0.99). Conversely, 31 patients (26.7%) from the high-risk group had clinical events (positive predictive value 26.7%, 95% CI 0.19 to 0.35), mainly conductive disorders requiring pacemaker (n = 26; 14.7%). In multivariate analysis, right bundle branch block (odds ratio [OR] 14.1, 95% CI 3.5 to 56.3), use of the self-expandable valve without a pacemaker (OR 5.5, 95% CI 2 to 16.3), vitamin K antagonist treatment (OR 3.8, 95% CI 1.1 to 12.6), and female gender (OR 2.6, 95% CI 1.003 to 6.9) were preprocedural predictive factors of adverse events. In conclusion, our results suggested that TAVI can be performed safely without ICU admission in selected patients. This strategy may optimize efficiency and cost-effectiveness of procedures.

Hybrid Aortic Repair of Dissecting Aortic Arch Aneurysm after Surgical Treatment of Acute Type A Dissection.

BACKGROUND: The aim of this study was to evaluate the short-term and midterm results of hybrid repair of dissecting aortic arch aneurysms subsequent to surgical treatment of acute type A dissections. METHODS: Between 2003 and 2014, 7 consecutive patients, previously operated for acute type A dissection, underwent hybrid repair of their aortic arch for a dissecting aortic arch aneurysm (6 men, mean age 62 ± 11 years). Aneurysm formation requiring treatment in these aortic arches was observed from 2 to 20 years after the initial aortic dissection repair. A hybrid technique was used in all patients, with supra-aortic debranching through a redo sternotomy and either simultaneous (6 patients) or staged endovascular stent grafting (1 patient). Two patients were treated in an emergent setting (1 ruptured and 1 symptomatic aneurysm). Two patients required a more extensive aortic repair of either the thoracic aorta (n, 1) or of the thoracoabdominal aorta (n, 1). One patient underwent, saphenous vein bypass from the ascending aorta to the anterior descending coronary artery on full cardiopulmonary bypass. Follow-up computed tomography scans were performed at 1 week, 3, and 6 months, and annually thereafter. RESULTS: Technical success was achieved in all the cases. One transient ischemic attack, 1 stroke, and 1 episode of transient spinal cord ischemia were observed. Thirty-day mortality was not observed. A type I endoleak at 6 months was successfully treated with deployment of a second stent graft. After a mean follow-up of 3.5 ± 3.1 years (range, 0.4-9.6 years), no aortic-related mortality was observed. No cases of stent-graft migration or secondary rupture were observed. CONCLUSIONS: Our experience demonstrates the promising potential of endovascular repair of dissecting aortic arch aneurysms after surgical treatment of acute type A dissection. The potential to diminish the magnitude of the surgical procedure and the consequences of aortic arch exposure, and above all avoiding the need for circulatory arrest are promising and mandate further investigation to determine the efficacy and durability of this technique.

Management and outcome of patients supported with Impella 5.0 for refractory cardiogenic shock.

INTRODUCTION: Cardiogenic shock refractory to standard therapy with inotropes and/or intra-aortic balloon pump is accompanied with an unacceptable high mortality. Percutaneous left ventricular assist devices may provide a survival benefit for these very sick patients. In this study, we describe our experience with the Impella 5.0 device used in the setting of refractory cardiogenic shock. METHODS: In this observational, retrospective, single-center study we included all the consecutive patients supported with Impella 5.0, between May 2008 and December 2013, for refractory cardiogenic shock. Patients' baseline and procedural characteristics, hemodynamics and outcome to the first 48 h of support, to ICU discharge and day-28 visit were collected. RESULTS: A total of 40 patients were included in the study. Median age was 57 years and 87.5 % were male. Cardiogenic shock resulted from acute myocardial infarction in 17 patients (43 %), dilated cardiomyopathy in 12 (30 %) and postcardiotomy cardiac failure in 7 (18 %). In 15 patients Impella 5.0 was added to an ECMO to unload the left ventricle. The median SOFA score for the entire cohort prior to circulatory support was 12 [10-14] and the duration of Impella support was 7 [5-10] days. We observed a significant decrease of the inotrope score (10 [1-17] vs. 1 [0-9]; p = 0.04) and the lactate values (3.8 [1.7-5.9] mmol/L vs. 2.5 [1.5-3.4] mmol/L; p = 0.01) after 6 h of support with Impella 5.0. Furthermore, at Impella removal the patients' left ventricular ejection fraction improved significantly (p < 0.001) when compared to baseline. Cardiac recovery, bridge to left ventricular assist device or heart transplantation was possible in 28 patients (70 %). Twenty-six patients (65 %) survived at day 28. A multivariate analysis showed a higher risk of mortality for patients with acute myocardial infarction (hazard ratio = 4.1 (1.2-14.2); p = 0.02). CONCLUSIONS: Impella 5.0 allowed fast weaning of inotropes and might facilitate myocardial recovery. Despite high severity scores at admission, day-28 mortality rate was better than predicated.