Balloon aortic valvuloplasty in the era of transcatheter aortic valve replacement: acute and long-term outcomes.

BACKGROUND: The use of balloon aortic valvuloplasty (BAV) has resurged since the development of transcatheter aortic valve replacement (TAVR). The aim of our study was to determine the procedural and long-term outcomes of patients treated by BAV in the early TAVR era. METHODS: From 2005 to 2008, 323 consecutive patients presenting with severe aortic stenosis were treated by BAV in our institution. RESULTS: Mean age and logistic EuroSCORE were 80.5 ± 9.9 years and 28.7% ± 12.5%, respectively. The effective orifice area increased from 0.68 ± 0.25 to 1.12 ± 0.39 cm(2) (P < .001) after BAV. Inhospital major complications occurred in 22 patients (6.8%), with a mortality rate of 2.5%. Eighty-five patients (26.3%) were bridged to surgical aortic valve replacement (SAVR, 9.6%) or TAVR (16.7%). Twenty-eight patients (8.7%) had at least 1 repeat BAV. Two hundred ten patients (65%) received only medical therapy post-BAV. Mean duration of follow-up was 20.7 ± 20.0 months. Kaplan-Meier analysis demonstrated that survival after single BAV was poor. Patients treated by BAV followed by SAVR or TAVR had the highest long-term survival rate (P < .001). Multivariable analysis revealed that logistic EuroSCORE, severe aortic regurgitation and stroke complications post-BAV, and medical therapy post-BAV were independent predictors of mortality. CONCLUSIONS: The results of our study suggest that BAV is an acceptable bridge to SAVR or TAVR in a very high-risk population not immediately suitable for definitive therapy. Balloon aortic valvuloplasty remains only a brief temporizing procedure with a poor long-term outcome without subsequent definitive therapy.

Expandable sheath for transfemoral transcatheter aortic valve replacement: procedural outcomes and complications.

AIMS: It is currently unknown whether the expandable sheath (e-sheath) for transfemoral Edwards transcatheter aortic valve replacement (TAVR) has a lower rate of access complications than the 18/19F fixed size sheath (f-sheath). Our aim was to compare the incidence of procedural complications when using f-sheath vs. e-sheath during TAVR. METHODS: We included 162 consecutive patients, implanted with the Edwards SAPIEN XT valve in our center. Access closure was obtained with the Prostar system in all cases. E-sheath was used in 80 patients (49%). RESULTS: Minimal ilio-femoral diameter was comparable in e-sheath and f-sheath groups: 6.7 (6.1-7.7) vs. 7 (6.2-8) mm, P = 0.25, as was the frequency of peripheral artery disease: 12.5% vs. 13.4%, P = 1.0. VARC major vascular complications rate was similar in the 2 groups: e-sheath 7 (8.8%) vs. f-sheath 6 (7.3%), P = 0.74, as was the incidence of minor vascular complications: 8 (10%) vs. 14 (17.1%), P = 0.19, life-threatening bleeding: 6 (7.5%) vs. 6 (7.3%), P = 0.96, major and minor bleeding and use of covered vascular stents: 9 (11%) vs. 6 (7.5%), P = 0.59. CONCLUSIONS: The e-sheath for TAVR with the Edwards valve did not show an advantage over the f-sheath in reducing vascular and bleeding complications.

Laparoscopic gastric plication for the treatment of morbid obesity by using real-time imaging of the stomach pouch.

BACKGROUND: Bariatric surgery is a continuously evolving field. Laparoscopic greater curvature plication is a new investigational procedure used to treat patients with morbid obesity. The demand for this operation from the obese patients is also rising. The problem is that during gastric plication the exact dimensions and volume of the pouch are not known so frequently it is too large or too tight thus compromising the results. The aim of the study was to identify the parameters that can improve the outcomes after this procedure. METHODS: We performed laparoscopic greater curvature plication in 75 obese patients during 2013-2015. The last 25 patients underwent surgery with a modified surgical technique using real-time imaging of the stomach pouch. The inclusion criteria for the 25 patients enrolled in this case series were the usual, body mass index higher than 40 or higher than 35 but with comorbidities along with the option of the patients for laparoscopic gastric plication. The operative technique was enhanced by using a computerized device and special intragastric catheters during the procedure that permitted real-time imaging of the gastric geometry. With this new operative approach we obtained the desired volume of the gastric remnant and we avoided strictures, obstruction or irregular shape of the pouch, problems that otherwise could have compromised the outcomes. RESULTS: We found an increased excess weight loss of 55% at six month and 65% over a 12-month follow-up period with alleviation of comorbidities. There were no major complications (gastric outlet obstructions or leaks) and less minor complications (nausea and vomiting) than in the patients operated with classic gastric plication procedure. CONCLUSIONS: This study shows that in case of laparoscopic gastric plication the use of our modified operative technique has better outcomes than in the classical setting. This is a new operative approach in the bariatric literature which can lead to greater acceptance of gastric plication among bariatric surgeons. The target population is represented by the obese patients who want to obtain similar results to those after gastric bypass and sleeve gastrectomy but are concerned about removing a part of their stomach and the postoperative complications that may occur, especially leaks and nutritional complications. KEY WORDS: Gastric geometry, Laparoscopic gastric plication, Morbid obesity, Real-time imaging.

Does residual aortic regurgitation after transcatheter aortic valve implantation increase mortality in all patients? The importance of baseline natriuretic peptides.

BACKGROUND: Aortic regurgitation (AR) is an important complication of transcatheter aortic valve implantation (TAVI) and even moderate AR is associated with increased mortality after TAVI. The association with decreased survival is unclear. We aimed to analyse the impact of AR after TAVI as a function of baseline NT-proBNP. METHODS: We included 236 consecutive patients implanted in our centre with the SAPIEN and SAPIEN XT valves, via the transfemoral route. AR was evaluated by transthoracic echocardiography. NT-proBNP was measured 24h before implantation and patients were divided according to the median value. RESULTS: Median age was 85 years (80-89) and 137 (58.1%) were women. Patients with high NT-proBNP had lower left ventricular ejection fraction: 52% (35-65) vs. 63% (55-70), p<0.001, larger telediastolic diameters: 56 mm (49-61) vs. 52 mm (46-56), p=0.01, and more severe aortic stenosis: 0.62 ± 0.15 cm(2) vs. 0.70 ± 0.2 cm(2), p<0.001. Pre-procedural moderate or severe AR (42% vs. 26%, p=0.013) and mitral regurgitation (56% vs. 36%, p=0.004) were more common in the high NT-proBNP group. After TAVI, moderate or severe AR occurred in 26% of patients and was associated with increased 2-year mortality only in the low NT-proBNP group, while patients in the high NT-proBNP group were not affected. CONCLUSIONS: Moderate or severe AR after TAVI was not associated with increased 2-year mortality in patients with high baseline NT-proBNP. Our data suggest that the impact of AR after TAVI is absent in patients with significant pre-procedural AR or mitral regurgitation and more severe aortic stenosis.

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.

Implantable cardioverter-defibrillators in lamin A/C mutation carriers with cardiac conduction disorders.

BACKGROUND: Sudden cardiac death is frequent in patients with lamin A/C gene (LMNA) mutations and may be related to ventricular arrhythmias (VA). OBJECTIVE: To evaluate a strategy of prophylactic implantable cardioverter-defibrillator (ICD) implantation in LMNA mutation carriers with significant cardiac conduction disorders. METHODS: Forty-seven consecutive patients (mean age 38 ± 11 years; 26 men) were prospectively enrolled between March 1999 and April 2009. Prophylactic ICD implantation was performed in patients with significant cardiac conduction disorders: patients requiring permanent pacing for bradycardia or already implanted with a pacemaker at the initial presentation, or patients with a PR interval of >0.24 seconds and either complete left bundle branch block or nonsustained ventricular tachycardia. RESULTS: Twenty-one (45%) patients had significant conduction disorders and received a prophylactic ICD. Among ICD recipients, no patient died suddenly and 11 (52%) patients required appropriate ICD therapy during a median follow-up of 62 months. Left ventricular ejection fraction was ≥45% in 9 patients at the time of the event. Among the 10 patients without malignant VA, device memory recorded nonsustained ventricular tachycardia in 8 (80%). The presence of significant conduction disorders was the only factor related to the occurrence of malignant VA (hazard ratio 5.20; 95% confidence interval 1.14-23.53; P = .03). CONCLUSIONS: Life-threatening VAs are common in patients with LMNA mutations and significant cardiac conduction disorders, even if left ventricular ejection fraction is preserved. ICD is an effective treatment and should be considered in this patient population.

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.

[Selection of patients for transcatheter aortic valve implantation]. / Implantation de valve aortique percutanée : sélection des patients.

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

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.

OBJECTIVES: The authors report the feasibility and 30-day outcomes of transfemoral aortic valve replacement (TAVR), using the Edwards SAPIEN (Edwards Lifesciences, Irvine, California) and Edwards SAPIEN XT (Edwards Lifesciences) prosthesis, implanted using exclusively local anesthesia and fluoroscopic guidance. BACKGROUND: Transfemoral TAVR is often managed with general anesthesia. However, a simplified percutaneous approach using local anesthesia has become more popular because it offers multiple advantages in an elderly and fragile population. METHODS: Between May 2006 and January 2011, the authors prospectively evaluated 151 consecutive patients (logistic EuroSCORE: 22.8 ± 11.8%) who underwent TAVR (SAPIEN: n = 78, SAPIEN XT: n = 73) using only local anesthesia and fluoroscopic guidance. The primary endpoint was a combination of all-cause mortality, major stroke, life-threatening bleeding, stage 3 acute kidney injury (AKI), periprocedural myocardial infarction (MI), major vascular complication, and repeat procedure for valve-related dysfunction at 30 days. RESULTS: Transarterial femoral approach was surgical in all SAPIEN procedures and percutaneous in 97.3% of SAPIEN XT, using the ProStar vascular closure device, and was well tolerated in all cases. Conversion to general anesthesia was required in 3.3% (SAPIEN cases) and was related to complications. Vasopressors were required in 5.5%. Procedural success was 95.4%. The combined-safety endpoint was reached in 15.9%, including overall mortality (6.6%), major stroke (2.0%), life-threatening bleeding (7.9%), stage 3 AKI (0.7%), periprocedural MI (1.3%), major vascular complication (7.9%), and repeat procedure for valve-related dysfunction (2.0%) at 30 days. A permanent pacemaker was required in 5.3%. CONCLUSIONS: This single-center, prospective registry demonstrated the feasibility and safety of a simplified transfemoral TAVR performed using only local anesthesia and fluoroscopic guidance in high surgical risk patients with severe aortic stenosis.

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

BACKGROUND: A new generation of balloon-expandable valves (e.g. Edwards SAPIEN XT) enables the use of a decreased sheath size using the NovaFlex™ delivery system for transfemoral transcatheter aortic valve implantation (TAVI). However, there are few data analysing the efficacy and safety of this new prosthesis. AIMS: To evaluate periprocedural and 30-day clinical outcomes using the Edwards SAPIEN XT compared with the first-generation Edwards SAPIEN prosthesis. METHODS: Between May 2006 and October 2011, consecutive high-risk or non-operable patients with severe aortic stenosis had TAVI using an Edwards SAPIEN or SAPIEN XT prosthesis. Valve Academic Research Consortium endpoints were used. RESULTS: Of 250 patients who underwent TAVI, 190 were performed transfemorally (78 SAPIEN and 112 SAPIEN XT). Transfemoral access was possible more often using SAPIEN XT (112/123 [91.1%] vs 78/127 [61.4%]; P<0.001). Mean logistic EuroSCORE was significantly lower in the SAPIEN XT group (18.1±11.0% vs 27.3±11.1%; P<0.0001), and the iliofemoral artery minimal lumen diameter was smaller (6.7±1.2 vs 8.5±1.3mm; P<0.0001). Device success was similar in both groups (95.5% for SAPIEN XT and 93.6% for SAPIEN), as was the 30-day combined safety endpoint (15.2% and 17.9%, respectively). At 30days, prosthesis performance was similar in both groups. CONCLUSIONS: Short-term safety and performance analysis of the latest generation of balloon-expandable valve, the SAPIEN XT, seem similar to the previous generation. However, transfemoral implantation is more often possible, related to sheath size reduction.

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

BACKGROUND: The first French transapical transcatheter aortic valve implantation (TAVI) was performed in July 2007 in our department. AIMS: To report 4-year outcomes of transapical implantation with the Edwards transcatheter bioprosthesis. METHODS: We prospectively evaluated consecutive patients who underwent transapical implantation with an Edwards transcatheter bioprosthesis between July 2007 and October 2011. Patients were not suitable for conventional surgery (due to severe comorbidities) or transfemoral implantation (due to poor femoral access). RESULTS: Among 61 patients (59.0% men), mean logistic EuroSCORE was 27.5 ± 14.9% and mean age was 81.0 ± 6.8 years. Successful valve implantation was achieved in 59/61 patients (96.7%) of patients. The other two patients required conversion to conventional surgery due to prosthesis embolization and died. Six additional patients died in the postoperative period. Causes of perioperative death were two septic shocks (one of peritonitis), two multi-organ failure, one ventricular fibrillation and one respiratory insufficiency. Intraprocedural stroke was not observed in any patient. The actuarial survival rates at 1, 2 and 4 years were 73.8%, 67.2% and 41.0%. During this 4-year period, four patients died of cardiovascular events, but no impairment of transprosthesis gradient was observed. CONCLUSION: Our series of 61 patients who underwent transapical implantation of the Edwards transcatheter bioprosthesis shows satisfactory results, similar to other reports, considering the high level of severity of patients referred for this method. Transapical access is a reliable alternative method for patients that cannot benefit from a transfemoral approach.