Pulmonary valve replacement in a large and tortuous right ventricle outflow tract with a 32†mm Myval valve under local anaesthesia: challenges and technical considerations: a case report.

Background: Pulmonary valve replacement in patients with congenital heart diseases and heart failure is challenging. Case summary: Here, we describe a case of a patient who had surgical fallot repair with chronic heart failure. Investigations found severe biventricular dysfunction and enlargement due to chronic pulmonary regurgitation. The right ventricle outflow tract was tortuous and large with a diameter of 35 mm. Percutaneous pulmonary valve implantation (PPVI) was done after a challenging pre-stenting. A 32 mm Myval valve over-sized to 35 mm was used for PPVI, which yielded a good result. Discussion: A 32 mm Myval valve is effective at extending the possibilities of PPVI in a large and tortuous right ventricle outflow tract not accessible for the other valves.

Transcatheter aortic valve implantation with the Evolut platform for bicuspid aortic valve stenosis: the international, multicentre, prospective BIVOLUTX registry.

BACKGROUND: Prospective data about transcatheter aortic valve implantation (TAVI) in bicuspid aortic valve (BAV) patients are limited. AIMS: We aimed to evaluate the clinical impact of the Evolut PRO and R (34 mm) self-expanding prostheses in BAV patients and explore the impact of different computed tomography (CT) sizing algorithms in a prospective registry. METHODS: A total of 149 bicuspid patients were treated in 14 countries. The primary endpoint was the intended valve performance at 30 days. Secondary endpoints were 30-day and 1-year mortality, severe patient-prosthesis mismatch (PPM) and the ellipticity index at 30 days. All study endpoints were adjudicated according to Valve Academic Research Consortium 3 criteria. RESULTS: The mean Society of Thoracic Surgeons score was 2.6% (1.7-4.2). Type I L-R BAV was observed in 72.5% of the patients. Evolut valve sizes 29 and 34 mm were utilised in 49.0% and 36.9% of the cases, respectively. The 30-day cardiac death rate was 2.6%; the 1-year cardiac death rate was 11.0%. Valve performance at 30 days was observed in 142/149 (95.3%) patients. The mean aortic valve area post-TAVI was 2.1 (1.8-2.6) cm2, and the mean aortic gradient was 7.2 (5.4-9.5) mmHg. No patient had more than moderate aortic regurgitation at 30 days. PPM was observed in 13/143 (9.1%) surviving patients and was severe in 2 patients (1.6%). Valve function was maintained at 1 year. The mean ellipticity index remained 1.3 (interquartile range 1.2-1.4). Overall, 30-day and 1-year clinical and echocardiography outcomes were similar between the two sizing strategies. CONCLUSIONS: BIVOLUTX demonstrated a favourable bioprosthetic valve performance and good clinical outcomes after TAVI with the Evolut platform in patients with bicuspid aortic stenosis. No impact from the sizing methodology could be identified.

Incidence, source, and prognostic impact of major bleeding across the spectrum of aortic stenosis.

BACKGROUND: Severe aortic stenosis (AS) has been associated with bleeding. However, there is a lack of prospective assessment of bleeding events and their clinical significance in a large population of outpatients with variable degree of AS severity. OBJECTIVES: To assess the incidence, source, determinants, and prognostic impact of major bleeding in patients with variable degree of AS severity. METHODS: Between May 2016 and December 2017, consecutive outpatients were included. Major bleeding was defined as type ≥3 bleed using the Bleeding Academic Research Consortium definition. Cumulative incidence was calculated with death as the competing event. Data was censored at time of aortic valve replacement. RESULTS: Among 2,830 patients, 46 major bleeding events occurred (0.7%/year) during a median follow-up of 2.1 years (interquartile range: 1.4-2.7). Most frequent sites of bleeding were gastrointestinal (50%) and intracranial (30.4%). Major bleeding was significantly associated with all-cause mortality (hazard ratio: 5.93 (95% confidence interval 3.64-9.65); P < .001). AS severity was associated with major bleedings (P = .041). By multivariable analysis, severe AS was an independent determinant of major bleeding (hazard ratio vs mild AS: 3.59 [95% confidence interval 1.56-8.29]; P = .003). The increased risk of bleeding associated with severe AS was significantly exacerbated in patients using oral anticoagulation. CONCLUSION: In AS patients, major bleeding is rare but a strong independent predictor of death. AS severity is a determinant of bleeding events. Severe AS and oral anticoagulation should be identified as an association at very high risk of major bleeding.

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.

Balloon aortic valvuloplasty for severe aortic stenosis before urgent non-cardiac surgery.

BACKGROUND: Balloon aortic valvuloplasty (BAV) has been proposed as a therapeutic option in patients suffering from severe aortic stenosis (SAS) who need urgent non-cardiac surgery (NCS). Whether this strategy is better than medical therapy in this very specific population is unknown. AIMS: We aimed to evaluate the clinical benefit of an invasive strategy (IS) with preoperative BAV in patients with SAS requiring urgent NCS. METHODS: From 2011 to 2019, a registry conducted in two centres included 133 patients with SAS undergoing urgent NCS, of whom 93 underwent preoperative BAV (IS) and 40 a conservative strategy (CS) without BAV. All analyses were adjusted for confounding using inverse probability of treatment weighting (IPTW) (10 clinical and anatomical variables). RESULTS: The primary outcome was MACE at one-month follow-up after NCS including mortality, heart failure, and other cardiovascular outcomes. In patients managed conservatively, occurrence of MACE was 20.0% (n=8) and death was 10.0% (n=4) at 1 month. In patients undergoing BAV, the occurrence of MACE was 20.4% (n=19) and death was 5.4% (n=5) at 1 month. Among patients undergoing conservative management, all events were observed after NCS while, in patients undergoing BAV, 12.9% (n=12) had events between BAV and NCS including 3 deaths, and 7.5% (n=7) had events after NCS including 2 deaths. In IPTW propensity analyses, the incidence of the primary outcome (20.4% vs 20.0%; OR 0.93, 95% CI: 0.38-2.29) and three-month survival (89.2% vs 90.0%; IPTW-adjusted HR 0.90, 95% CI: 0.31-2.60) were similar in both groups. CONCLUSIONS: Patients with SAS managed conservatively before urgent NCS are at high risk of events. A systematic invasive strategy using BAV does not provide a significant improvement in clinical outcome.

Feasibility and safety of transfemoral transcatheter aortic valve implantation performed with a percutaneous coronary intervention-like approach.

BACKGROUND: Transfemoral percutaneous transcatheter aortic valve implantation (TF-TAVI) is a safe, reproducible and established procedure, mainly performed under local anaesthesia, which is mostly administered and monitored by a dedicated anaesthesia team (regular approach). Our centre has developed a standardized pathway of care, and eligible patients are selected for a minimalist TF-TAVI, entirely managed by operators without the presence of the anaesthesia team in the operating room, like most interventional coronary procedures ("percutaneous coronary intervention-like" approach [PCI approach]). AIM: To compare the safety and efficacy of TF-TAVI performed with the PCI approach versus the regular approach. METHODS: The analysis population comprised all patients who underwent TF-TAVI with the PCI or regular approach in our institution from November 2016 to July 2019. The two co-primary endpoints were early safety composite and early efficacy composite at 30days as defined by the Valve Academic Research Consortium-2. The PCI (n=137) and Regular (n=221) approaches were compared using the propensity score based method of inverse probability of treatment weighting. RESULTS: No differences were observed after comparison of TAVI performed with the PCI or regular approach regarding the composite safety endpoint (7.3% vs. 11.3%; odds ratio 0.63, 95% confidence interval 0.37 to 1.07; P=0.086) or the composite efficacy endpoint (4.4% vs. 6.3%; odds ratio 0.78, 95% confidence interval 0.41 to 1.49; P=0.45). CONCLUSIONS: This study suggests that the efficacy and safety of TF-TAVI entirely managed by a PCI approach for selected patients are not different to those when TF-TAVI is performed with the attendance of a full anaesthesia care team. The PCI approach appears to be a safe and efficient clinical pathway, providing an appropriate and rational utilization of anaesthesiology resources, and could be used for the majority of TF-TAVI procedures.

Clinical significance of electrocardiographic markers of myocardial damage prior to aortic valve replacement.

BACKGROUND: Pre-operative myocardial fibrosis and remodeling impact on outcomes after aortic valve replacement (AVR). We aimed at investigating the prognostic impact of preoperative electrocardiographic (ECG) markers of left ventricular (LV) myocardial damage, i.e. bundle branch block (BBB) and ECG strain pattern after (surgical or transcatheter) AVR for severe aortic stenosis (AS). METHODS: Between April 2008 and October 2017, we explored consecutive patients referred to our Heart Valve Clinic for first AVR for severe AS. Detailed pre-operative phenotyping and ECG analysis were performed. Patients were followed-up after AVR for major cardiac events (ME), i.e. cardiovascular death, cardiac hospitalization for acute heart failure and stroke. RESULTS: BBB and ECG strain were respectively observed in 13.5 and 21% of the 1122 patients included. These ECG markers identified a subgroup of older patients, with higher NYHA class and more advanced myocardial disease as detected by echocardiography, i.e. higher LV mass and lower LV ejection fraction, global longitudinal strain and integrated backscatter, than patients without ECG strain or BBB. ME occurred in 212 (18.6%) patients during a mean follow-up of 4.4 ± 1.5 years with higher incidence in case of ECG strain or BBB (HR 1.56, 95%CI 1.13-2.14, p = 0.006; HR 1.47, 95%CI 1.02-2.13, p = 0.04 respectively). The prognostic value of ECG strain remained significant after adjustment for age, diabetes and pre-operative LVEF. CONCLUSIONS: Pre-operative ECG markers of myocardial damage identify a subgroup of AS patients at high risk of post-AVR cardiovascular complications irrespective of other prognostic factors and should help the multiparametric staging of cardiac damage to guide AVR.

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.

Accuracy of cardiac magnetic resonance imaging to rule out significant coronary artery disease in patients with systolic heart failure of unknown aetiology: Single-centre experience and comprehensive meta-analysis.

BACKGROUND: Coronary artery disease (CAD) is the leading cause of systolic heart failure (HF). Cardiac magnetic resonance imaging (CMR) is a non-invasive technique that detects a myocardial infarction scar as subendocardial or transmural late gadolinium enhancement (st-LGE). AIM: We sought to evaluate whether a lack of st-LGE could rule out CAD in new-onset systolic HF of unknown aetiology. METHODS: We included 232 consecutive patients with new-onset HF and left ventricular ejection fraction ≤35% who underwent both coronary angiography and CMR to assess HF aetiology. CAD was defined as the presence of coronary artery stenosis≥50% on a coronary angiogram. We assessed sensitivity, specificity, and positive and negative likelihood ratios (PLR and NLR) of the presence of st-LGE to detect underlying CAD. A complementary meta-analysis of 11 studies (including ours) was also performed. RESULTS: In our study, 49 (21.1%) patients had CAD. The sensitivity and specificity of the presence of st-LGE to detect CAD were 69 and 92%, respectively. PLR and NLR were 8.47 and 0.33, respectively. In the meta-analysis, 1227 patients were included, and the prevalence of CAD ranged from 19.2 to 68.3%. Sensitivity, specificity, PLR and NLR were 87% (95% confidence interval [CI] 0.80-0.92), 93% (95% CI 0.89-0.96), 12.91 (95% CI 7.70-21.64) and 0.14 (95% CI 0.09-0.22), respectively. Altogether, 55 patients presented CAD with no st-LGE; inversely, 75 patients presented st-LGE with no CAD. CONCLUSION: With a CMR specificity of 93%, the absence of st-LGE rules out significant underlying CAD in patients with systolic HF of unknown aetiology in most cases.

Urgent balloon aortic valvuloplasty in patients with cardiogenic shock related to severe aortic stenosis: time matters.

AIMS: The aim of the study was to assess the outcomes of balloon aortic valvuloplasty (BAV) as a rescue therapy in patients with cardiogenic shock (CS) related to severe aortic stenosis (AS). METHODS AND RESULTS: Forty-four consecutive patients, n=31 with hypotensive CS (HCS) and n=13 with non-hypotensive CS (NHCS) due to acutely decompensated severe AS, from two centres were treated with urgent BAV. The composite primary endpoint was mortality or recurrent CS at one-year follow-up. These patients (77.3±8.1 years old; 75% male) had a mean EuroSCORE II of 41.6±13.7%. One-month mortality was 47%. Twelve patients (27%) had either a staged TAVR (n=10) or surgical aortic valve replacement (SAVR) (n=2) with a median delay of 79 days after BAV: n=6 (19%) in the HCS subgroup and n=6 (46%) in the NHCS population (p=0.06). At one year, the rate of composite all-cause death or recurrent CS was 75% and significantly higher in the HCS subgroup (83% vs. 53%; p=0.03). Overall one-year mortality was 70% (n=31) with a trend for a better prognosis in NHCS patients (54% vs. 77%; p=0.09). Univariate predictive factors of the primary endpoint included preoperative dose of dobutamine >5 microg/kg/min (100% vs. 57%; p=0.001) and delayed BAV >48 hrs (90% vs. 59%; p=0.01). CONCLUSIONS: Despite the initial success of urgent BAV, morbidity and mortality of CS related to severe AS remain high and directly related to the time of the valvuloplasty. Performing BAV before or within 48 hours of starting inotropic agents appears to be key to survival.

Advanced image processing with fusion and calcification enhancement in transcatheter aortic valve implantation: impact on radiation exposure.

OBJECTIVES: Radiation exposure is a concern for both patients and operators during transcatheter aortic valve implantation (TAVI). Efforts to reduce radiation dose are warranted. We aimed at investigating if per-operative advanced image processing can reduce patient and operator irradiation use during TAVI. METHODS: We performed a prospective single-centre observational study comparing patient and operator radiation exposure using standard fluoroscopy (control group) or a novel technology of live advanced fluoroscopic image processing (test group) among consecutive patients undergoing TAVI between August 2015 and April 2016. Patient irradiation (dose-area product, effective dose and air kerma), contrast media volume and clinical outcomes were assessed. RESULTS: Among 152 elderly [median age (interquartile range): 83 (78-87)] patients (n = 76 per group) undergoing TAVI, baseline clinical characteristics were similar between the control and test groups, except for a higher median EuroSCORE II (2.8% vs 2.3%, P = 0.02) and higher rate of TAVI for failing surgical bioprosthesis (11.8% vs 2.6%, P = 0.03) in the control group. The dose-area product was reduced in the test group: mean reduction of -27.5 Gy × cm2 [95% confidence intervals (CIs): 15.9-39.1, P < 0.001]. Furthermore, effective dose [mean reduction -6.5 (95% CI: 5.9-7.2) mSv, P < 0.001] and air kerma [mean reduction -167.5 (95% CI 163.4-177.3) mGy, P < 0.001] were lower in the test group. Fluoroscopy time, contrast volume and clinical outcomes were similar. CONCLUSIONS: Patient radiation exposure was significantly reduced using a novel live advanced fluoroscopy image processing with calcification enhancement and fusion of the virtual aortic annulus without compromising patient safety.

Successful transcatheter aortic valve implantation for severe aortic stenosis of a bicuspid valve with situs inversus totalis guided by advanced image processing: a case report.

INTRODUCTION: Transcatheter aortic valve implantation (TAVI) can be challenging in case of complex anatomy such as bicuspid aortic valve stenosis or situs inversus. This report illustrates a successful procedure in a patient with both conditions after careful pre-operative planning and per-operative guidance by means of a novel software. CASE PRESENTATION: We report the case of a 71-year-old man that presented a type 0 bicuspid aortic valve stenosis and situs inversus. We performed transfemoral TAVI using the Edwards Sapien 3 transcatheter heart valve (THV) and a novel software that provides insight for patient anatomy through computed tomography (CT) extracted three-dimensional reconstruction before the procedure aiming at improving THV positioning during the procedure through fusion of a CT-extracted virtual aortic annulus on the fluoroscopy screen and enhancing of calcifications that can be considered as anatomical landmarks. The Edwards Sapien 3 THV was accurately implanted in a supra-annular fashion. Post-operative echocardiography showed an excellent result without any para-prosthetic leak, and the patient reported symptom improvement. DISCUSSION: During TAVI the angiographic appearance of the cusps of a bicuspid aortic valve is irregular and asymmetric, which can lead to malpositioning, paravalvular regurgitation, and increased rates of pacemaker implantation after TAVI. Furthermore, usual anatomical landmarks can be even more disturbed by the situs inversus totalis. We believe that pre-operative three-dimensional reconstruction and per-operative fluoroscopy image processing, provided by software such as the one presented in this case report, can provide precious guidance for TAVI in patients with complex and unusual anatomy.

Impact of QRS Duration on Decision of Early Removal of Pacing Catheter After Transcatheter Aortic Valve Replacement With CoreValve Device.

The purpose of this study was to determine the predictability of QRS duration (QRSd) for temporary pacing catheter removal in patients implanted with CoreValve. Permanent pacemaker implantation is a known complication after transcatheter aortic valve replacement (TAVI) with CoreValve. Although post-TAVI QRSd is highly predictive for advanced atrioventricular block (AVB), management of delayed AVB after TAVI remains unclear. We conducted a multicentric, prospective study of 156 consecutive patients who underwent TAVI with CoreValve between December 2010 and January 2013. Patients who had acute AVB after TAVI were excluded (n = 25). We classified the patients into 2 groups based on the post-TAVI QRSd. Patients with QRSd <120 ms were assigned to early pacing catheter removal group (n = 34), and patients with QRSd ≥120 ms were assigned to keep the pacing catheter with monitoring group (n = 97). No patient required permanent pacemaker implantation in the early pacing catheter removal group, whereas 38 patients with QRSd ≥120 ms had a delayed AVB (QRSd <120 ms vs ≥120 ms: 0% vs 39%, p = 0.0001). The intensive care unit stay length, 30-day mortality, and incidence of complications were lower in the early catheter removal group. Post-TAVI QRSd allows patient selection for early removal of pacing catheter in patients implanted with CoreValve.

Transcarotid Transcatheter Aortic Valve Replacement: General or Local Anesthesia.

OBJECTIVES: The study sought to assess the safety and efficacy of a minimally invasive strategy (MIS) (local anesthesia and conscious sedation) compared to general anesthesia (GA) among the largest published cohort of patients undergoing transcarotid transcatheter aortic valve replacement (TAVR). BACKGROUND: Transcarotid TAVR has been shown to be feasible and safe. There is, however, no information pertaining to the mode anesthesia in these procedures. METHODS: Between 2009 and 2014, 174 patients underwent transcarotid TAVR at 2 French centers. All patients were unsuitable for transfemoral TAVR due to severe peripheral vascular disease. An MIS was undertaken in 29.8% (n = 52) and GA in 70.1% (n = 122). One-year clinical outcomes were available in all patients and were described according to the Valve Academic Research Consortium-2 consensus. RESULTS: Transcarotid vascular access and transcatheter valve deployment was successful in all cases. Thirty-day mortality was 7.4% (n = 13) and 1-year all-cause and cardiovascular mortality were 12.6% (n = 22) and 8.0% (n = 14), respectively. According to the type of anesthesia, there was no between group difference in 30-day mortality (GA 7.3% vs. MIS 7.6%; p = 0.94), 1-year mortality (GA 13.9% vs. MIS 9.6%; p = 0.43), 1-month clinical efficacy (GA 85.2% vs. MIS 94.2%; p = 0.09), and early safety (GA 77.8% vs. MIS 86.5%; p = 0.18). There were 10 (5.7%) periprocedural cerebrovascular events: 4 strokes (2.2%) and 6 transient ischemic attacks (3.4%) among those treated with GA. There was neither stroke nor transient ischemic attack in the MIS group (p < 0.001). CONCLUSIONS: The transcarotid approach for TAVR is feasible using general or local anesthesia. A higher rate of perioperative strokes was observed with GA.

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.

Prognostic value of the ratio between prosthesis area and indexed annulus area measured by MultiSlice-CT for transcatheter aortic valve implantation procedures.

BACKGROUND: Postprocedural aortic regurgitations following transcatheter aortic valve implantation (TAVI) procedures remain an issue. Benefit of oversizing strategies to prevent them isn't well established. We compared different level of oversizing in our cohort of consecutive patients to address if severe oversizing compared to normal sizing had an impact on post-procedural outcomes. METHODS: From January 2010 to August 2013, consecutive patients were referred for TAVI with preoperative Multislice-CT (MSCT) and the procedures were achieved using Edwards Sapien(®) or Corevalve devices(®). Retrospectively, according to pre-procedural MSCT and the valve size, patients were classified into three groups: normal, moderate and severe oversizing; depending on the ratio between the prosthesis area and the annulus area indexed and measured on MSCT. Main endpoint was mid-term mortality and secondary endpoints were the Valve Academic Research Consortium (VARC-2) endpoints. RESULTS: Two hundred and sixty eight patients had a MSCT and underwent TAVI procedure, with mainly Corevalve(®). While all-cause and cardiovascular mortality rates were similar in all groups, post-procedural new pacemaker (PM) implantation rate was significantly higher in the severe oversizing group (P = 0.03), while we observed more in-hospital congestive heart-failure (P = 0.02) in the normal sizing group. There was a trend toward more moderate to severe aortic regurgitation (AR) in the normal sizing group (P = 0.07). CONCLUSIONS: Despite a higher rate of PM implantation, oversizing based on this ratio reduces aortic leak with lower rates of post-procedural complications and a similar mid-term survival.

Catheter tip erosion due to Rotablator burr: An unusual complication.

We report the occurrence of catheter tip erosion during use of a Rotablator, a rare but serious complication. A heavily calcified lesion of the right coronary artery ostium required use of a Rotablator, and the need for strong push led to the choice of an Amplatz Left guiding catheter. The traction of the catheter toward the ostium and the subsequent angle generated led to friction of the burr against the catheter and the erosion of its tip. If judged essential to get strong support, the Amplatz catheter should be used with caution in this setting.

Transcarotid Transcatheter Aortic Valve Replacement: Feasibility and Safety.

OBJECTIVES: The purpose of this study was to assess the feasibility and safety of transcarotid transcatheter aortic valve replacement (TAVR). BACKGROUND: Many candidates for TAVR have challenging vascular anatomy that precludes transfemoral access. Transcarotid arterial access may be an option for such patients. METHODS: The French Transcarotid TAVR Registry is a voluntary database that prospectively collected patient demographics, procedural characteristics, and clinical outcomes among patients undergoing transcarotid TAVR. Outcomes are reported according to the updated Valve Academic Research Consortium criteria. RESULTS: Among 96 patients undergoing transcarotid TAVR at 3 French sites (2009 to 2013), the mean age and Society of Thoracic Surgeons predicted risk of mortality were 79.4 ± 9.2 years and 7.1 ± 4.1%, respectively. Successful carotid artery access was achieved in all patients. The Medtronic CoreValve (Medtronic, Inc., Minneapolis, Minnesota) (n = 89; 92.7%) and Edwards SAPIEN valves (Edwards Lifesciences, Irvine, California) (n = 7; 7.3%) were used. Procedural complications included: valve embolization (3.1%), requirement for a second valve (3.1%), and tamponade (4.2%). There were no major bleeds or major vascular complications related to the access site. There were 3 (3.1%) procedural deaths and 6 (6.3%) deaths at 30 days. The 1-year mortality rate was 16.7%. There were 3 (3.1%) cases of Valve Academic Research Consortium-defined in-hospital stroke (n = 0) or transient ischemic attack (TIA) (n = 3). None of these patients achieved the criteria for stroke and none manifested new ischemic lesions on cerebral computed tomography or magnetic resonance imaging. At 30 days, a further 3 TIAs were observed, giving an overall stroke/TIA rate of 6.3%. CONCLUSIONS: Transcarotid vascular access for TAVR is feasible and is associated with encouraging short- and medium-term clinical outcomes. Prospective studies are required to ascertain if transcarotid TAVR yields equivalent results to other nonfemoral vascular access routes.