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.

Frequency of conduction disturbances after transcatheter implantation of an Edwards Sapien aortic valve prosthesis.

We evaluated the incidence of conduction abnormalities and requirement for permanent pacemaker in patients undergoing transcatheter aortic valve implantation (TAVI) with the Edwards Sapien prosthesis. In 2009, >8,000 patients were treated with TAVI using 1 of the 2 commercialized models of bioprosthesis (Edwards Sapien, Edwards Lifesciences, Irvine, California; and CoreValve, Medtronic, Irvine, California). Occurrence of conduction abnormalities including complete atrioventricular block requiring permanent pacemaker has been reported after TAVI with the 2 models of valve, more frequently with the CoreValve. We analyzed standard 12-lead electrocardiograms of 69 consecutive patients in whom an Edwards Sapien prosthesis was successfully implanted. Electrocardiograms were examined before treatment, at day 1, and at 1-month follow-up. Heart rate, PR and QT intervals and QRS duration were measured and the presence of a first-, second-, or third-degree atrioventricular block was documented. There was a slight increase in heart rate and a discrete decrease in QT interval at day 1. These values had returned to baseline values at 1 month. There was no change in PR interval but a transitory increase in QRS duration was noted. Frequency of left bundle branch block increased from 14.5% at baseline to 27.5% at day 1 with a decreased incidence at day 30 (21.3%). Permanent pacemaker was required in only 3 patients (4.3%). In conclusion, in our experience, conductive disorders and requirement of a definitive pacemaker after implantation of an Edwards Sapien aortic bioprosthesis are infrequent. The physical properties of this prosthesis may explain this observation.

Aorto-iliac angiography as a screening tool in selecting patients for transfemoral aortic valve implantation with the Edwards SAPIEN bioprosthesis.

AIMS: Transcatheter aortic valve replacement (TAVR) is a promising therapeutic option for patients with severe aortic stenosis (AS) considered at too high risk for conventional aortic valve replacement. The balloon-expandable Edwards valve can be implanted using either the transfemoral or transapical routes, depending on arterial ilio-femoral suitability. The aim of the study was to evaluate the usefulness of ilio-femoral angiography as an initial screening tool for TAVR using the transfemoral approach with the Edwards SAPIEN valve. METHODS AND RESULTS: Aortography with bilateral ilio-femoral run-off was assessed in the antero-posterior projection. Minimal arterial diameter, vessel tortuosity and calcification were assessed. Transfemoral implantation was appropriate when the minimal arterial diameter was >7 mm for a 23 mm trans-catheter heart valve (THV) and >8 mm for a 26 mm THV with limited calcifications and tortuosity. Included were 135 patients with severe aortic stenosis undergoing cardiac catheterisation before conventional aortic valve replacement or TAVR. Mean femoral artery diameter was 7.5+/-1.3 mm and mean iliac artery diameter was 9.3+/-2.3 mm. There was no or moderate tortuosity in 72% of them. Calcifications were absent or moderate in 83%. At first sight, the transfemoral route was considered potentially suitable in 71% of patients for a 23 mm THV and 39% of patients for a 26 mm TAVI. CONCLUSIONS: In the course of haemodynamic and angiographic evaluation of patients with severe symptomatic aortic stenosis, angiography of the ilio-femoral access can be used as a first screening modality to determine potential candidacy for a transfemoral TAVR using a balloon expandable THV.

Analysis of nonintervention strategy for in-stent restenosis in Pauci- or asymptomatic patients.

Between January 1996 and May 2000, we retrospectively identified 66 patients (61 +/- 11 years) with in-stent restenosis who did not undergo percutaneous coronary intervention and/or bypass surgery and were maintained on medical treatment alone. In-stent restenosis was diffuse or proliferative in 86% of these patients. At 33 +/- 11 months, 2 patients died, none developed myocardial infarction, and 6 (9%) had target lesion revascularization only (repeat percutaneous transluminal coronary angioplasty). Medical treatment alone was associated with a good long-term clinical follow-up in selected patients with significant documented in-stent restenosis.

A randomized comparison of a percutaneous suture device versus manual compression for femoral artery hemostasis after PTCA.

BACKGROUND: The prolonged bed rest following femoral sheath removal after PTCA is a source of discomfort for the patient. We designed a randomized study to evaluate the efficacy and safety of an arterial suture device developed to percutaneously close the vascular access site after PTCA, allowing immediate sheath removal and early ambulation, compared to manual compression. METHODS: After successful PTCA, patients were randomized to manual compression or immediate femoral percutaneous closure. Exclusion criteria were arteritis, age > 80 years and > 3 previous femoral punctures on the same side. The two-needle device was used for the 6F sheath removal and the four-needle device for the 8F sheath. Ambulation was allowed 4 hours after the arterial suture. RESULTS: One hundred and sixty-seven patients (59 +/- 10 years, 81% males) were randomized to suture device (n = 91) or to manual compression (n = 76). The two groups were similar in terms of age, sex, size of sheath, number of patients with stent implantation (62 vs 61%), procedural anticoagulation. Procedural duration was 8 +/- 6 minutes with percutaneous suture versus 25 +/- 11 minutes with manual compression (P < 0.0001). Procedural success with percutaneous suture was 93% whereas six technical failures were treated with prolonged manual compression. Nonsurgical hematoma occurred in five patients (5%) with the suture device and in two (3%) with manual compression with no need for blood transfusion (P = NS). Uneventful blood oozing occurred in 11 patients (12%) with percutaneous suture and in only 2 (3%) with manual compression (P < 0.06). The tolerance of the hemostasis procedure and the length of post-procedure hospital stay (40 +/- 32 hours) were similar in the two groups. CONCLUSION: Percutaneous suture of the femoral artery, allows immediate closure of femoral puncture sites after PTCA, without increasing the incidence of vascular complications. The use of this device should allow earlier discharge and subsequent cost savings.