Dominik Scharnbeck

Transfemoral aortic valve implantation with the repositionable Lotus valve compared with the balloon-expandable Edwards Sapien 3 valve

BACKGROUND The rate of paravalvular aortic insufficiency (AI) with transcatheter aortic valve implantation (TAVI) with first generation devices was higher compared with surgical replacement. Residual AI after TAVI has been linked to an increased mortality rate. We compared two second generation TAVI devices - the repositionable Lotus valve with the balloon-expandable Edwards Sapien 3 valve - regarding procedural and 30 day outcome. METHODS AND RESULTS In 78 patients with severe aortic stenosis undergoing transfemoral TAVI we evaluated post-procedural paravalvular AI, device success and early safety according to VARC criteria. Valve size was based on a 256-multislice computed tomography. Patients were followed for 30 days. The Lotus valve (N = 26) and the Edwards Sapien 3 valve (N = 52) were implanted under fluoroscopic guidance. Baseline characteristics were similar between groups. Perimeter derived annulus diameter did not differ with 25.7 ± 1.6mm for Lotus and 25.2 ± 2.1mm for Edwards Sapien 3 patients. After TAVI aortography and transthoracic echocardiography revealed no moderate or severe AI. The rate of mild AI was 12% for Lotus and 15% for Edwards Sapien 3 (p = 0.62). There were no deaths, stroke, annulus rupture or coronary obstruction. Device success was 96% and 98% (p = 0.61), early safety according to VARC 11.5% in both groups (p = 1.0) and the need for pacemaker implantation 27% and 4% (p < 0.003), respectively. CONCLUSIONS TAVI with second-generation devices was associated with no moderate or severe AI and a low rate of mild AI. Device success was high for Lotus and Edwards Sapien 3 while the need for permanent pacemaker was significantly higher with the Lotus valve.

Transfemoral Aortic Valve Implantation with the New Edwards Sapien 3 Valve for Treatment of Severe Aortic Stenosis—Impact of Valve Size in a Single Center Experience

Aims The third generation Edwards Sapien 3 (Edwards Lifesciences Inc., Irvine, California) system was optimized to reduce residual aortic regurgitation and vascular complications. Methods and Results 235 patients with severe symptomatic aortic stenosis were prospectively enrolled. Transcatheter aortic valve implantations (TAVI) were performed without general anesthesia by transfemoral approach. Patients were followed for 30 days. Patients received 23mm (N = 77), 26mm (N = 91) or 29mm (N = 67) valve based on pre-procedural 256 multislice computer tomography. Mean oversizing did not differ between the 3 valves. There was no residual moderate or severe aortic regurgitation. Rate of mild aortic regurgitation and regurgitation index did not differ between groups. There was no switch to general anesthesia or conversion to surgery. Rate of major vascular complication was 3.0% with no difference between valve and delivery sheath sizes. Within 30 days rates of all cause mortality (2.6%) and stroke (2.1%) were low. Conclusions In patients with severe aortic stenosis transfemoral TAVI with the Edwards Sapien 3 valve without general anesthesia was associated with a high rate of device success, no moderate or severe residual aortic regurgitation, low rates of major vascular complication, mortality and stroke within 30 days with no difference between the 3 valve sizes. Trial Registration ClinicalTrials.gov NCT02162069

Very Low Tidal Volume Ventilation with Associated Hypercapnia - Effects on Lung Injury in a Model for Acute Respiratory Distress Syndrome

Background Ventilation using low tidal volumes with permission of hypercapnia is recommended to protect the lung in acute respiratory distress syndrome. However, the most lung protective tidal volume in association with hypercapnia is unknown. The aim of this study was to assess the effects of different tidal volumes with associated hypercapnia on lung injury and gas exchange in a model for acute respiratory distress syndrome. Methodology/Principal Findings In this randomized controlled experiment sixty-four surfactant-depleted rabbits were exposed to 6 hours of mechanical ventilation with the following targets: Group 1: tidal volume = 8–10 ml/kg/PaCO2 = 40 mm Hg; Group 2: tidal volume = 4–5 ml/kg/PaCO2 = 80 mm Hg; Group 3: tidal volume = 3–4 ml/kg/PaCO2 = 120 mm Hg; Group 4: tidal volume = 2–3 ml/kg/PaCO2 = 160 mm Hg. Decreased wet-dry weight ratios of the lungs, lower histological lung injury scores and higher PaO2 were found in all low tidal volume/hypercapnia groups (group 2, 3, 4) as compared to the group with conventional tidal volume/normocapnia (group 1). The reduction of the tidal volume below 4–5 ml/kg did not enhance lung protection. However, oxygenation and lung protection were maintained at extremely low tidal volumes in association with very severe hypercapnia and no adverse hemodynamic effects were observed with this strategy. Conclusion Ventilation with low tidal volumes and associated hypercapnia was lung protective. A tidal volume below 4–5 ml/kg/PaCO2 80 mm Hg with concomitant more severe hypercapnic acidosis did not increase lung protection in this surfactant deficiency model. However, even at extremely low tidal volumes in association with severe hypercapnia lung protection and oxygenation were maintained.

Transfemoral valve-in-valve implantation for degenerated bioprosthetic aortic valves using the new balloon-expandable Edwards Sapien 3 valve

Surgical aortic bioprosthetic valves deteriorate 10 to 20 years after operation. Valve‐in‐valve implantation with first generation transcatheter aortic valve implantation (TAVI) devices has shown to be feasible. We report a first case series with the new Edwards Sapien 3 valve for transfemoral aortic valve‐in‐valve implantation.

Transfemoral aortic valve implantation with the repositionable Lotus valve for treatment of patients with symptomatic severe aortic stenosis: results from a single-centre experience.

AIMS The aim of the study was to evaluate the procedural and 30-day results for the repositionable Lotus valve in patients undergoing transfemoral aortic valve implantation in a single-centre experience. METHODS AND RESULTS We prospectively enrolled 110 patients with severe symptomatic aortic stenosis (NCT02162069). All procedures were performed without general anaesthesia by the transfemoral approach. Patients were followed for 30 days. Patients received the 23 mm (n=20), 25 mm (n=43) or 27 mm (n=47) Lotus device. Mean oversizing in relation to annulus or left ventricular outflow tract (LVOT) did not differ among groups. There was no residual moderate or severe aortic regurgitation. The rate of mild aortic regurgitation was low at 9.1%. There was no valve embolisation, no need for a second valve and no conversion to surgery. The need for a new pacemaker implantation due to complete (third degree) or type II (Mobitz) second degree atrioventricular block was 24.1%, excluding patients with previously implanted devices. Within 30 days the rates of all-cause mortality and stroke were low. CONCLUSIONS In patients with severe aortic stenosis, transfemoral TAVI with the repositionable Lotus valve was associated with a high rate of device success, no moderate or severe residual aortic regurgitation, low rates of major vascular complications and mortality within 30 days.

Pulmonary pulse transit time: a novel echocardiographic indicator of hemodynamic and vascular alterations in pulmonary hypertension and pulmonary fibrosis.

Pulse transit time (PTT) is generally assumed to be a surrogate marker for blood pressure changes and arterial stiffness. The aim was to evaluate whether pulmonary PTT (pPTT) may be noninvasively measured by Doppler echocardiography and whether it might be valuable for detecting pulmonary hemodynamic and vascular alterations.

Transfemoral aortic valve implantation is more successful with the Edwards Sapien 3 compared with the Edwards XT for the treatment of symptomatic severe aortic stenosis

BACKGROUND Residual aortic regurgitation (AR) after transfemoral aortic valve implantation (TAVI) is associated with increased mortality. The new Edwards Sapien 3 valve (ES3) is designed to reduce paravalvular AR. AIM To compare a new-generation and a late-generation balloon-expandable transcatheter heart valve. METHODS In this study, 100 consecutive patients treated with the ES3 for symptomatic native severe aortic stenosis were compared with 100 consecutive patients treated with the Edwards Sapien XT valve (EXT); all valves were implanted via transfemoral access. We compared residual AR, rate of permanent pacemaker implantation, device success according to the second Valve Academic Research Consortium (VARC-2) criteria and 30-day follow-up. RESULTS With the ES3, the risk of moderate/severe AR was lower (0% vs 3%), the risk of mild AR was lower (31% vs 40%) and the final result with no AR was higher (P=0.07). The mean aortic gradient was significantly higher with the ES3 (12.2±4.6 vs 9.4±3.9mmHg; P<0.01). Device success according to the VARC-2 criteria was high with the ES3 and the EXT (97% vs 95%; P=0.48). Pacemaker implantation because of higher-grade atrioventricular block was similar: 9.3% after ES3 implantation and 6.9% after EXT implantation (P=0.56). There was significantly less major or life-threatening bleeding with the ES3: 5% vs 14% (P=0.03) and 0% vs 8% (P<0.01), respectively. After 30 days, the VARC-2 early-safety endpoint was significantly lower with the ES3 (P<0.01). CONCLUSIONS In conclusion, TAVI with the ES3 in patients with symptomatic severe aortic stenosis was associated with no moderate/severe AR, a trend towards a lower rate of mild AR, a significantly lower rate of major or life-threatening bleeding and early safety according to VARC-2 criteria within 30 days compared with the EXT.

TRANSFEMORAL AORTIC VALVE IMPLANTATION WITH THE NEW EDWARDS SAPIEN 3 VALVE FOR TREATMENT OF SEVERE AORTIC STENOSIS

The third generation Edwards Sapien 3 (Edwards Lifesciences Inc., Irvine, California) system was optimized to reduce residual aortic regurgitation and vascular complications. The study evaluated the post-procedural and 30 days results for the 23, 26 and 29mm Edwards Sapien 3 valve in patients

TCT-690 Influence of calcium, implantation depth and oversizing on the occurrence of conduction disturbances and need for pacemaker implantation after implantation of the balloon-expandable Edwards Sapien 3 valve

METHODS All TAVI cases performed in our center before May 2014 were done with the SAPIEN or XT (Edwards Lifesciences, Irvine CA) valve; from June 2014, the THV design (SAPIEN XT, SAPIEN 3 (Edwards Lifesciences) or LOTUS (Boston Sci, Boston, MA) was selected based on anatomical factors known to influence the risk of PVR. Patients without risk factors were implanted with the SAPIEN XT (n 1⁄4 51) while patients at higher risk received a LOTUS (n 1⁄4 25) or SAPIEN 3 (n 1⁄4 3). We compared the incidence of PVR and new pacemaker implantation in 112 patients implanted with SAPIEN or SAPIEN XT (Group A) before May 2014 to the 79 patients treated with either the SAPIEN XT, LOTUS or SAPIEN 3 valve (Group B) after June 2014. We prospectively recorded VARC II success rate, procedural complication and residual PVR.