Rescue aortic valvuloplasty for severe aortic stenosis is simple and effective in severely hemodynamically compromised patients presenting to centers without on-site heart surgery or TAVI facilities.

Management of high-risk patients with severe aortic stenosis (AS) is a challenging issue. The prognosis of patients with AS presenting with therapy-refractory pulmonary edema (RPE) or cardiogenic shock (CS) remains poor. The purpose of this study was to assess the 30-day mortality of rescue percutaneous balloon aortic valvuloplasty (PBAV) in AS patients presenting with RPE or CS in a community-based hospital without on-site heart surgery. From January 2016 to February 2019, we identified consecutively admitted patients with CS or RPE related to severe AS who underwent emergent PBAV. The primary end point was 30-day mortality. Secondary end points included procedural adverse events according to the Valve Academic Research Consortium (VARC)-2 criteria and predictive factors of the primary end point. We identified 51 patients with either CS (n = 22) or RPE (n = 29). All PBAV procedures were successful with a significant reduction in peak-to-peak gradient (median, [IQR] from 40 [27] mmHg to 15 [20] mmHg, p < 0.001). No procedural deaths occurred, while adverse events included stroke (4%), minor vascular complications (6%), minor (4%) and major bleedings (4%), and no life-threatening bleeding. Overall, 15 deaths (29%) were noted at 30 days after PBAV, while 53% of the surviving patients were successfully bridged to transcatheter aortic valve implantation (TAVI). 30-day mortality was significantly higher in the CS group compared to the RPE (n = 10 (45%) vs n = 5 (7%), p = 0.029), and was significantly associated with the presence of acute kidney injury (OR 9.09, 95% CI 2.13-38.77, p = 0.003) and elevated pulmonary artery systolic pressure (OR 1.06, 95% CI 1.0-1.12, p = 0.047). Rescue PBAV in patients with severe AS presenting with RPE or CS is a feasible and effective therapeutic option, even in a community-based hospital without on-site heart surgery. Rescue PBAV resulted in 30-day survival of more than 70%, with more than half of the surviving patients having been successfully bridged to TAVI.

Incidence, Predictor, and Clinical Outcomes of Multiple Resheathing With Self-Expanding Valves During Transcatheter Aortic Valve Replacement.

Background No study has evaluated the impact of the additional manipulation demanded by multiple resheathing (MR) in patients undergoing transcatheter aortic valve replacement with repositionable self-expanding valves. Methods and Results This study included a real-world, multicenter registry involving 16 centers from Canada, Germany, Latin America, and Spain. All consecutive patients who underwent transcatheter aortic valve replacement with the Evolut R, Evolut PRO, and Portico valves were included. Patients were divided according to the number of resheathing: no resheathing, single resheathing (SR), and MR. The primary end point was device success. Secondary outcomes included procedural complications, early safety events, and 1-year mortality. In 1026 patients, the proportion who required SR and MR was 23.9% and 9.3%, respectively. MR was predicted by the use of Portico and moderate/severe aortic regurgitation at baseline (both with P<0.01). Patients undergoing MR had less device success (no resheathing=89.9%, SR=89.8%, and MR=80%; P=0.01), driven by more need for a second prosthesis and device embolization. At 30 days, there were no differences in safety events. At 1 year, more deaths occurred with MR (no resheathing=10.5%, SR=8.0%, and MR=18.8%; P=0.014). After adjusting for baseline differences and center experience by annual volume, MR associated with less device success (odds ratio, 0.42; P=0.003) and increased 1-year mortality (hazard ratio, 2.06; P=0.01). When including only the Evolut R/PRO cases (N=837), MR continued to have less device success (P<0.001) and a trend toward increased mortality (P=0.05). Conclusions Repositioning a self-expanding valve is used in a third of patients, being multiple in ≈10%. MR, but not SR, was associated with more device failure and higher 1-year mortality, regardless of the type of valve implanted.

Non-invasive and invasive predictors of paravalvular regurgitation post CoreValve® stent prosthesis implantation in aortic valves.

OBJECTIVES: The long-term success of CoreValve® stent prosthesis (Medtronic) implantation for severe aortic valve stenosis is limited by postprocedural paravalvular regurgitation (PVR). METHODS: We have retrospectively investigated preinterventional cardiac 256-slice computed tomography (CT) scans and aortography to define predictors for mild, moderate, or severe PVR, in a blinded fashion. RESULTS: We investigated 100 consecutive patients with a mean aortic valve area (AVA) of 0.69 cm(2) and a mean age of 79.4 years. PVR was defined by echocardiography as mild (63), moderate (18), or severe (19). We found no differences according to AVA, left ventricular function, deployed stent size, calcification rate of the aortic valve, and stent position. Anatomically, the annular size and the angle between the left ventricular outflow tract (LVOT) and the ascending aorta demonstrated significant (P < 0.05) differences in the severity of the PVR: an LVOT: ascending aorta angle >12.6°, annulus area >8.9 cm(2) , and annulus diameter difference >3.9 mm. The multivariate analysis demonstrated that deviation angle, difference of aortic annulus (longitudinal-orthogonal), and CoreValve size were independent predictors of PVR. CONCLUSION: Our data demonstrate the feasibility of cardiac CT to evaluate predictors of PVR post-CoreValve placement. We support the aortic annulus (the area as well as the diameter differences) and the deviation of the linear slope from LVOT to ascending aorta as predictors of severe paravalvular regurgitations poststent implantation.

Non-invasive and invasive evaluation of aortic valve area in 100 patients with severe aortic valve stenosis: comparison of cardiac computed tomography with ECHO (transesophageal/transthoracic) and catheter examination.

BACKGROUND: Current guidelines place emphasis on the determination of aortic valve area (AVA) for defining an appropriate treatment strategy. Invasive and non-invasive modalities are used to perform planimetric [transesophageal echocardiography (TEE) and cardiac multidetector computed tomography (MDCT)] and calculated [catheter examination (CE), transthoracic echocardiography (TTE)] AVA measurements. PURPOSE AND METHODS: We investigated 100 patients admitted to evaluate the AVA using cardiac MDCT (CT), TEE/TTE as well as invasive CE. RESULTS: In all 100 patients we calculated a mean AVA of 0.79±0.29cm(2) (female 50/100, 0.70±0.19cm(2), male 0.9±0.21cm(2)) determined by all investigated examinations (mean±SEM). AVA measurements determined by CT were significantly greater (0.86±0.25cm(2)) than those determined by CE: 0.75±0.18cm(2), p=0.01. Echocardiographically determined AVA was comparable to CE (statistically not significant). Similar results were seen in all patients regardless of gender, presence of atrial fibrillation, and heart rate. We calculated a mean AVA for each patient and evaluated the variance of the AVA determined through investigated specific examinations as the bias. Overall, we found for CT 0.13±0.1cm(2), CE 0.13±0.11cm(2), TEE 0.16±0.09cm(2), and for TTE 0.16±0.08cm(2) a specific statistical non-significant variance. On subgroups: sinus rhythm, atrial fibrillation, females, males or combination, we found no further significant relevance for the specific variance. CONCLUSION: Our data suggest the feasibility of cardiac MDCT to evaluate the correct AVA regardless of rhythm, heart rate, and sex. The planimetric concept to determine the AVA with CT displaces the "gold-standard" CE with respect to elucidating the potencies for complications, i.e. cerebral stroke. Regardless of CT's accessing of AVA measurement the TTE examination should remain the primary method of screening for aortic valve pathologies.

Effects of tetrahydrobiopterin on nitric oxide bioavailability and renal hemodynamics in healthy volunteers.

BACKGROUND: The endothelial nitric oxide (NO) system plays a central role in regulating vascular tone. Endothelial dysfunction has been closely linked to reduced activity in the NO system. Tetrahydrobiopterin (BH4) is an essential cofactor of all NO synthase isoforms. METHODS: We examined the effects of BH4 on the NO system assessed by measurement of serum cGMP levels and NO breakdown products (NOx) in 12 healthy volunteers. RESULTS: Application of a total of 19 mg/kg BH4 intravenously (i.v.) over 3 hours led to a dose-dependent increase in serum cGMP concentrations from a median 3.3 nM (interquartile range [IQR] 1.1-5.6) to 5.7 nM (IQR 2.4-13.3, p=0.008) and NOx from a median 49.3 microM (IQR 39.8-56.6) to 59.7 microM (39.6-85.5) (p=0.058). Systemic and renal hemodynamics measured by inulin and p-aminohippuric acid (PAH) clearance remained unchanged. Plasma renin activity was significantly increased (2.0 [IQR 1.0-2.8] to 2.3 ng AngI/mL per hour [IQR 1.7-4.0], p=0.045), whereas aldosterone, erythropoietin and B-type natriuretic peptide levels did not change. In a second study, oral BH4 given over 3 days (800 mg/day) similarly increased serum cGMP and ameliorated the depressive effects of the NO synthase inhibitor L-NAME (1.5 mg/kg i.v.) on the glomerular filtration rate. CONCLUSIONS: Application of BH4 in high doses is safe and enhances formation of cGMP, pointing to increased bioavailability of NO.