Gauthier Mouillet

Clinical Outcomes and Safety of Transfemoral Aortic Valve Implantation Under General Versus Local Anesthesia Subanalysis of the French Aortic National CoreValve and Edwards 2 Registry

Background—Transcatheter aortic valve implantation (TAVI) performed under local anesthesia (LA) is becoming increasingly common. We aimed to compare the clinical outcomes in patients who underwent transfemoral-TAVI under general anesthesia (GA) and LA. Methods and Results—Data from 2326 patients in the French Aortic National CoreValve and Edwards 2 (FRANCE 2) registry who underwent transfemoral-TAVI were analyzed. During the study period, the percentage of LA procedures increased gradually from 14% in January 2010 to 59% in October 2011. The clinical outcomes for GA (n=1377) and LA (n=949) were compared. Numerous baseline characteristics differed between the 2 groups, and the use of transesophageal echocardiographic guidance was more common in GA than in LA (76.3% versus 16.9%; P<0.001). Device success and cumulative 30-day survival rates were similar in the 2 groups (97.6% versus 97.0%; P=0.41 and 91.6% versus 91.3%; P=0.69, respectively), whereas the incidence of postprocedural aortic regurgitation≥mild was significantly lower in GA than in LA (15.0% versus 19.1%; P=0.015). The groups were also analyzed using a propensity-matching model, including transesophageal echocardiographic usage (GA [n=401] versus LA [n=401]). This model indicated that there were no significant differences between the 2 groups in the rates of 30-day survival (GA [91.4%] versus LA [89.3%]; P=0.27] and postprocedural aortic regurgitation≥mild (GA [12.7%] versus LA [16.2%]; P=0.19). Conclusions—The less invasive transfemoral-TAVI under LA is preferred in clinical settings and seems to be acceptable; however, the higher incidence of postprocedural aortic regurgitation is emphasized. Therapeutic efforts should be made to reduce such complications during transfemoral-TAVI under LA.

Renal function-based contrast dosing predicts acute kidney injury following transcatheter aortic valve implantation.

OBJECTIVES This study sought to assess whether the volume of contrast media (CM) influences the occurrence of acute kidney injury (AKI) following transcatheter aortic valve implantation (TAVI). BACKGROUND The volume of CM has been shown to be associated with increasing risk of AKI; however, in a high-risk elderly TAVI population, the predictive value and optimal threshold of CM dose on AKI remain uncertain. METHODS Data of 415 consecutive transfemoral TAVI patients (age 83.6 ± 6.8 years, logistic EuroSCORE 23.0 ± 12.2%) were analyzed. AKI was defined by Valve Academic Research Consortium criteria. Based on a previous formula, the ratio of CM to serum creatinine (SCr) and body weight (BW) (CM × SCr/BW) was calculated as defining the degree of CM use. The association between CM dose and incidence of AKI, as well as predictive factors and prognosis of AKI, were investigated. RESULTS AKI occurred in 63 patients (15.2%). Cumulative 1-year mortality showed significant differences between the AKI and non-AKI groups (47.9% vs. 15.7%, p < 0.001). Mean CM × SCr/BW ratio was higher in the AKI group than in the non-AKI group (4.1 ± 2.9 vs. 2.9 ± 1.6, p < 0.001). By multivariate analysis, CM × SCr/BW per 1.0 increase, ejection fraction <40%, and transfusion were associated with the occurrence of AKI (odds ratio [OR]: 1.16; 95% confidence interval [CI]: 1.03 to 1.20; p = 0.017, OR: 3.01; 95% CI: 1.49 to 5.00; p = 0.001, OR: 2.73; 95% CI: 1.54 to 6.15; p = 0.001, respectively). A threshold value of CM × SCr/BW for predicting AKI was statistically identified as 2.7. CONCLUSIONS Although mechanisms of AKI following TAVI are multifactorial, the present study identified a relationship between CM dose increment and high prevalence of AKI. Therapeutic efforts not to exceed the threshold value may reduce the risk of AKI.

Baseline Characteristics and Prognostic Implications of Pre-Existing and New-Onset Atrial Fibrillation After Transcatheter Aortic Valve Implantation: Results From the FRANCE-2 Registry.

OBJECTIVES The aim of this study was to determine baseline characteristics and clinical outcomes of patients with pre-existing atrial fibrillation (AF) and of patients who presented with new-onset AF after transcatheter aortic valve implantation (TAVI). BACKGROUND Little is known regarding the impact of AF after TAVI. METHODS The FRANCE-2 registry included all patients undergoing TAVI (N = 3,933) in France in 2010 and 2011. New-onset AF was defined as the occurrence of AF post-procedure in a patient with no documented history of AF. RESULTS AF was documented before TAVI in 25.8% of patients. New-onset AF was observed in 174 patients after TAVI among patients without a history of pre-existing AF (6.0%). At 1 year, the rates of all-cause death (26.5 vs. 16.6%, respectively; p < 0.001) and cardiovascular death (11.5 vs. 7.8%, respectively; p < 0.001) were significantly higher in patients with pre-existing AF compared with those without AF. Rehospitalization for worsening heart failure and New York Heart Association functional class was also higher in patients with pre-existing AF versus those without, resulting in a higher rate of combined efficacy endpoint in this group (p < 0.001). A history of stroke, surgical (nontransfemoral) approach, cardiological, and hemorrhagic procedure-related events were all independently related to the occurrence of new-onset post-procedural AF. New-onset AF in patients without pre-existing AF was associated with a higher rate of combined safety endpoint at 30 days (p < 0.001) and a higher rate of both all-cause death and combined efficacy endpoint at 1 year (p = 0.003 and p = 0.02, respectively). CONCLUSIONS Pre-existing and new-onset AF are both associated with higher mortality and morbidity after TAVI.

Comparison of Effectiveness and Safety of Transcatheter Aortic Valve Implantation in Patients Aged >90 Years Versus <90 Years

In a fraction of patients aged ≥90 years, less-invasive transcatheter aortic valve implantation (TAVI) has been considered a therapeutic option for aortic stenosis under careful clinical screening. However, the safety and effectiveness using TAVI in such a population has not been fully elucidated. The aim of the present study was to investigate the feasibility of TAVI in nonagenarians. We prospectively enrolled 136 consecutive patients with severe aortic stenosis who were referred for TAVI. The procedural, early, and midterm clinical outcomes were compared between patients aged <90 years (n = 110, average age 82.3 ± 8.3 years) and ≥90 years (n = 26; average age 91.6 ± 1.9 years). A comparison of the baseline characteristics revealed that among patients aged ≥90 years, the prevalence of women (50% vs 81%, p <0.001) and the mean aortic valve gradient (45.5 ± 15.4 vs 56.3 ± 23.4 mm Hg, p = 0.005) were greater than those in patients aged <90 years. Major vascular complications occurred more frequently in patients ≥90 years (5% vs 19%, p = 0.022), although the rate of procedural success and 30-day and 6-month mortality were not different between the 2 age groups (96% vs 100%, p = 0.58; 6% vs 15%, p = 0.22; and 14% vs 27%, p = 0.14, respectively). The mortality rates were greater among patients aged ≥90 years. At 6 months, both groups of survivors were similar in symptom status, with a New York Heart Association classification less than class II (89% vs 84%, p = 0.68). The cumulative survival (median 13.4 ± 8.0 months of follow-up) was not significantly different between the 2 age groups (p = 0.22, log-rank test). In conclusion, even very elderly nonagenarians can experience acceptable clinical results and benefits after TAVI.

Impact of chronic kidney disease on the outcomes of transcatheter aortic valve implantation: results from the FRANCE 2 registry.

AIMS The aim of this study was to assess the influence of chronic kidney disease (CKD) classification on clinical outcomes in patients undergoing transcatheter aortic valve implantation (TAVI). METHODS AND RESULTS Data of 2,929 consecutive patients undergoing TAVI in the FRANCE 2 registry were analysed. Patients were divided into five groups: CKD 1+2, 3a, 3b, 4, and 5. Both 30-day and one-year mortality rates were significantly increased and positively correlated with CKD severity in all groups. After adjusting for significant influential confounders in a Cox regression multivariate model, CKD 4 and 5 were associated with increased risk of both 30-day mortality and one-year mortality when compared with CKD 1+2 as the reference. This higher mortality was predominantly driven by renal failure and infection in patients with CKD 4 and 5, respectively. Procedural success rate in CKD 5 was significantly lower than that in other groups. All CKD patients trended towards a higher incidence of acute kidney injury (AKI), in parallel with the degree of CKD severity. CONCLUSIONS Classification of CKD stages before TAVI allows risk stratification for 30-day and one-year clinical outcomes. CKD 3b, 4 and 5 correlate with poor outcome and are considered a significant risk for TAVI.

Clinical results of transcatheter aortic valve implantation in octogenarians and nonagenarians: insights from the FRANCE-2 registry.

BACKGROUND Although transcatheter aortic valve implantation has been developing as an alternative treatment in elderly patients with high surgical risk, age-specific differences in clinical outcome have not been fully validated. METHODS Data were analyzed for 2,254 patients at least 80 years old who were enrolled between January 2010 and October 2011 in the French national transcatheter aortic valve implantation registry, FRANCE-2. Procedural and clinical outcomes defined according to the Valve Academic Research Consortium criteria were compared among subjects in three age groups: 80 to 84 years (n = 867), 85 to 89 years (n = 1,064), and at least 90 years (n = 349; range, 90 to 101 years). RESULTS The self-expandable prosthesis was implanted in 710 patients, and the balloon-expandable prosthesis was implanted in 1,544 patients. No differences were observed in rates of procedural success, Valve Academic Research Consortium-defined complications, and length of hospitalization among groups. Cumulative 30-day mortalities did not change among the three groups (80 to 84 years, 10.3% versus 85 to 89 years, 9.5% versus ≥ 90 years, 11.2%; p = 0.53). Cumulative 1-year mortalities also showed no statistical differences, although the mortality rate was higher in patients 85 to 89 years old and at least 90 years old compared with those 80 to 84 years old (19.8% versus 26.1% versus 27.7%; p = 0.16). After adjustment for differential baseline characteristics and potential confounders, patient age (85 to 89 years and ≥ 90 years compared with 80 to 84 years) was not associated with increasing risk of 30-day mortality (hazard ratio, 0.92, 1.26; 95% confidence interval, 0.66 to 1.27, 0.83 to 1.94; p = 0.38, 0.28, respectively) and 1-year mortality (hazard ratio, 1.16, 1.36; 95% confidence interval, 0.90 to 1.49, 0.97 to 1.89; p = 0.25, 0.073, respectively). CONCLUSIONS This study revealed acceptable clinical results of transcatheter aortic valve implantation even in very elderly populations.

Prognostic Value of QRS Duration After Transcatheter Aortic Valve Implantation for Aortic Stenosis Using the CoreValve

Transcatheter aortic valve implantation (TAVI) is effective in treating severe aortic stenosis in high-risk surgical patients. We evaluated the value of the QRS duration (QRSd) in predicting the mid-term morbidity and mortality after TAVI. We conducted a prospective cohort study of 91 consecutive patients who underwent TAVI using the CoreValve at our teaching hospital cardiology unit in 2008 to 2010 who survived to hospital discharge; 57% were women, and their mean age was 84 ± 7 years. The QRSd at discharge was used to classify the patients into 3 groups: QRSd ≤120 ms, n = 18 (20%); QRSd >120 ms but ≤150 ms, n = 30 (33%); and QRSd >150 ms, n = 43 (47%). We used 2 end points: (1) all-cause mortality and (2) all-cause mortality or admission for heart failure. After a median of 12 months, the normal-QRSd patients showed a trend toward, or had, significantly better overall survival and survival free of admission for heart failure compared with the intermediate-QRSd group (p = 0.084 and p = 0.002, respectively) and the long-QRSd group (p = 0.015 and p = 0.001, respectively). The factors significantly associated with all-cause mortality were the Society of Thoracic Surgeons score, aortic valve area, post-TAVI dilation, acute kidney injury, hospital days after TAVI, and QRSd at discharge. On multivariate analysis, QRSd was the strongest independent predictor of all-cause mortality (hazard ratio 1.036, 95% confidence interval 1.016 to 1.056; p <0.001) and all-cause mortality or heart failure admission (hazard ratio 1.025, 95% confidence interval 1.011 to 1.039; p <0.001). The other independent predictors were the Society of Thoracic Surgeons score, acute kidney injury, and post-TAVI hospital days. In conclusion, a longer QRSd after TAVI was associated with greater morbidity and mortality after 12 months. The QRSd at discharge independently predicted mortality and morbidity after TAVI.

Effect of Body Mass Index <20 kg/m2 on Events in Patients Who Underwent Transcatheter Aortic Valve Replacement

The Valve Academic Research Consortium-2 has defined body mass index (BMI) <20 as indicative of frailty, which may be one of the co-morbidities not captured by traditional risk factors after transcatheter aortic valve replacement (TAVR). This study aimed to assess the impact of low BMI on clinical outcomes after TAVR. A total of 777 consecutive patients scheduled for TAVR were classified into 3 groups as BMI <20 (n = 56), 20 to 24.9 (n = 322), and ≥25 (n = 399). Procedural complications and clinical outcomes were compared among the 3 groups. They were also analyzed according to propensity-matching model A (BMI <20 [n = 50] vs ≥20 [n = 50]), model B (BMI <20 [n = 50] vs 20 to 24.9 [n = 50]), and model C (BMI <20 [n = 47] vs ≥25 [n = 47]). The differences in baseline characteristics among the 3 groups were adequately adjusted in 3 matched models. Valve Academic Research Consortium-2-defined end points and other complications were similar among the 3 groups in each model. Kaplan-Meier curves indicated no significant differences in cumulative 30-day survival (BMI <20 [91.0%] vs 20 to 24.9 [86.3%], p = 0.33; BMI <20 [91.0%] vs ≥25 [91.4%], p = 0.91, respectively) and 1-year survival (BMI <20 [74.3%] vs 20 to 24.9 [71.8%], p = 0.71; BMI <20 [74.3%] vs ≥25 [77.0%], p = 0.71; respectively). These survival rates were also similar in each of the 3 matched models. In conclusion, BMI <20 was not associated with increased early or midterm mortality. BMI <20 alone may not constitute an additional co-morbidity factor in patients who underwent TAVR.

Transcatheter aortic valve implantation when classical access routes are unavailable

A 90‐year‐old woman with symptomatic degenerative aortic stenosis had a logistic Euroscore greater than 53.29%, indicating a high surgical risk. She was therefore advised to undergo transcatheter aortic valve implantation. Both iliac arteries showed subocclusive calcifications, and the left subclavian artery was narrow and calcified. The left common carotid (LCC) artery was chosen as the access route. After surgical exposure of the LCC artery, the Corevalve Revalving 29‐mm bioprosthesis was implanted successfully. No access‐site complications occurred. In our experience, a substantial proportion of elderly patients have vascular lesions precluding use of the femoral route. Brachiocephalic access routes may be valuable when no other options are available.

Prognostic value of new onset atrial fibrillation after transcatheter aortic valve implantation: A FRANCE 2 registry substudy.

BACKGROUND The development of new onset atrial fibrillation (NOAF) post-transcatheter aortic valve implantation (TAVI) is common and may be associated with an adverse prognosis. This study seeks to identify incidence, predictors, and impact of NOAF post-TAVI. METHODS From the multicenter study of the French national transcatheter aortic valve implantation registry, FRANCE 2, a total of 1959 patients with sinus rhythm prior to TAVI were enrolled into this study. The incidence of post-TAVI NOAF, predictors of development of NOAF and impact on 30-day and 1-year-mortalities were assessed. RESULTS Of the 1959 TAVI patients (mean-age: 82.6 ± 7.5 years, mean-logistic-EuroSCORE: 21.8 ± 14.3), 149 (7.6%) developed NOAF with the remaining 1810 (92.4%) control patients demonstrating no evidence of AF as defined by the Valve Academic Research Consortium (VARC). Advanced age and major and life-threatening bleeding were independent predictors of NOAF (95% CI: 0.93-0.99; p=0.006, 95% CI: 1.58-4.00; p<0.001, 95% CI: 1.09-3.75; p=0.025, respectively). A trend towards a higher incidence of major and life-threatening bleeding was observed in the patients undergoing TAVI via the transapical (TA)-approach compared with the transfemoral (TF)-approach. Both 30-day and cumulative 1-year-mortalities were significantly higher in patients with NOAF compared to patients without NOAF (3.0% vs. 7.4%; p=0.005, 9.1% vs. 20.8%; p<0.001, respectively). In addition, NOAF was an independent predictor of 30-day and 1-year-mortalities (HR: 2.16; 95% CI: 1.06-4.41; p=0.033, HR: 2.12; 95% CI: 1.42-3.15; p<0.001, respectively). CONCLUSION Advanced age and major and life-threatening bleeding were independently associated with increased incidence of NOAF, which itself was an independent predictor of 30-day and 1-year-mortalities. With regards to the various transcatheter approaches, a trend towards a higher incidence of major and life-threatening bleeding was observed only with the TA-approach.