Smita Scholtz

Device landing zone calcification and its impact on residual regurgitation after transcatheter aortic valve implantation with different devices

AIMS Calcification of the device landing zone is linked to paravalvular regurgitation after transcatheter aortic valve implantation (TAVI). The mechanisms remain incompletely understood and the performance of next-generation transcatheter heart valves (THV) has not been investigated. We evaluated the impact of calcification patterns on residual aortic regurgitation (AR) after TAVI with different THV in patients with severe aortic stenosis. METHODS AND RESULTS TAVI was performed in 537 patients at two centres. Devices implanted were the Edwards Sapien XT (n = 254), Medtronic CoreValve (n = 123), JenaValve (n = 62), Medtronic Engager (n = 56), and Symetis Acurate (n = 42) prostheses. Calcification of the device landing zone was retrospectively assessed from contrast-enhanced multidetector computed tomography data and correlated with echocardiographic and clinical data. Calcium volumes of the aortic valve and left-ventricular outflow tract were associated with residual AR: No AR, 604 mm(3) (inter-quartile range, IQR 349-916); trace AR, 639 mm(3) (IQR 368-948); mild AR, 710 mm(3) (IQR 412-2078); ≥moderate AR, 1041 mm(3) (IQR 791-1417, P = 0.001). Device landing zone calcium, particularly if located in the left-ventricular outflow tract, and a low cover index were predictive of AR. Differences in the incidence of AR were observed with regard to THV type. Higher calcium volume was associated with the need for post-dilation (n = 134, median 852 [IQR 342-945] vs. 604 [IQR 542-1207] mm(3), P < 0.001). CONCLUSION Calcification of the device landing zone, particularly if located inferior to the annulus, was independently associated with residual AR after TAVI with all evaluated THV; however, the incidence of paravalvular leakage differed significantly between the devices implanted.

Impact of closure devices on vascular complication and mortality rates in TAVI procedures

BACKGROUND Currently two closure devices are available for the vascular access in TAVI procedures. Their impact on vascular complications and mid-term mortality is yet unknown. METHODS Between 2009 and 2014, 398 patients underwent TAVI TF procedures in which two different closure devices were used, Prostar® XL (n=215) and Perclose-Proglide® (n=183). In the cases with Prostar we used one device and in cases with Perclose-Proglide, two devices. The two groups were compared with respect to the criteria of the Valve Academic Research Consortium (VARC) II. The mean follow-up period was 679.7±481.8 (727) days. RESULTS There were no significant differences in the baseline characteristics of both patient groups. In the Prostar® group, complications were more frequent (26.6% vs. 12.6%, p=0.005); in detail, these were bleeding (14.9% vs. 7.1%, [p]=0.02), suture rupture (4.7% vs. 1.3%, p=0.04), and pseudoaneurysms (10.2% vs. 1.2%, p<0.001). Multivariate regression analysis revealed two predictors for vascular complications: female sex (OR 2.3; 95% CI 1.3-3.8, p=0.002) and closure devices (OR 0.5; 95% CI 0.3-0.8, p=0.007) in favour of Proglide®. There was no significant difference in 30-day mortality (Prostar: 5.6±1.6% vs. Proglide: 4.9±1.6%). However, Kaplan-Meier survival analysis showed a significantly higher survival rate over the entire follow-up period for the Proglide® group (p=0.03). CONCLUSION Vascular complications occurred more often in the Prostar® group. Although 30-day mortality showed no significant difference between the groups, the mortality over complete follow-up was significantly lower in the Proglide® group.

Left ventricular adaptation after TAVI evaluated by conventional and speckle-tracking echocardiography.

OBJECTIVE Our study aimed to evaluate myocardial adaption and outcome after transfemoral aortic valve implantation (TAVI TF) for severe aortic stenosis by LV ejection fraction (LVEF) and speckle tracking analysis. METHODS AND RESULTS From 168 patients who underwent TAVI TF between 2010 and 2013 in our institution, n=95 with a follow-up period ≥3months were included and grouped (G) according to baseline left ventricular ejection fraction (LVEF; G1: LVEF<40%, G2: 40%-55%, G3: >55%). LV function was evaluated using conventional and speckle-tracking based parameters. Mortality was tracked up to 60months. Aortic valve orifice diameter and mean aortic gradient improved significantly after TAVI. LV dimensions and LVEF remained largely unchanged. Systolic function significantly improved in G1 (LVEF, p<0.001, global longitudinal strain [GLS], p=0.02) but deteriorated in G3 (LVEF, p=0.004, GLS, p=0.03). It did not change in G2. Diastolic function parameters improved significantly only in G3. Changes of LVEF and GLS were also statistically significant between G1 and G3 (LVEF p<0.0001, GLS p=0.004). Patients exhibited a higher survival rate with an LVEF increase >8% than with LVEF deterioration >8% (p=0.04). GLS changes had no significant impact on mortality. CONCLUSION In patient with aortic stenosis and LVEF impairment at baseline, TAVI results in an improved LVEF, while patients with a high LVEF at baseline experience a normalization of LVEF after TAVI. Independent of the baseline value, a deterioration of LVEF leads to a significant increase in mortality.

A multicentre European registry to evaluate the Direct Flow Medical transcatheter aortic valve system for the treatment of patients with severe aortic stenosis

AIMS Our aim was to assess the clinical outcomes of the Direct Flow Medical Transcatheter Aortic Valve System (DFM-TAVS), when used in routine clinical practice. METHODS AND RESULTS This is a prospective, open-label, multicentre, post-market registry of patients treated with DFM-TAVS according to approved commercial indications. Echocardiographic and angiographic data were evaluated by an independent core laboratory and adverse events were adjudicated and classified according to VARC-2 criteria by an independent clinical events committee. The primary endpoint was freedom from all-cause mortality at 30 days post procedure. Secondary endpoints included procedural, early safety and efficacy endpoints at 30 days. Two hundred and fifty patients with severe aortic stenosis undergoing transcatheter aortic valve implantation (TAVI) with the DFM-TAVS were enrolled in 21 European centres. The primary endpoint, freedom from all-cause mortality at 30 days, was met in 98% (245/250) of patients. Device success was 83.8%. Moderate or severe aortic regurgitation was reported in 3% of patients, and none/trace regurgitation in 73% of patients. Post-procedural permanent pacemaker implantation was performed in 30 patients (12.0%). CONCLUSIONS The DFM-TAVS was associated with good short-term outcomes in this real-world registry. The low pacemaker and aortic regurgitation rates confirm the advantages of this next-generation transcatheter heart valve (THV).

Impact of sheath diameter of different sheath types on vascular complications and mortality in transfemoral TAVI approaches using the Proglide closure device

Objective Evaluation of the impact of the sheath diameter on vascular complications and mortality in transfemoral aortic valve implantation. Method Between 2012 and 2014, 183 patients underwent the procedure using a sheath diameter of 18–24 F. This collective was divided into two groups: group 1, with a sheath diameter of 18F (G1, n = 94), consisted of patients with 18F Medtronic Sentrant and 18 F Direct Flow sheaths, and group 2 with a sheath diameter of 19–24 F (G2, n = 89) consisted of patients with Edwards expandable e-sheath and Solopath sheaths. Perclose-Proglide® was used as a closure device in all patients. Results G1 had significantly more female patients (64.9% vs. 46.1% in G2, p = 0.01) and the average BMI was lower (26 ± 4.5% vs. 27.4 ± 4.7%, p = 0.03). There was no significant difference in the incidence of major and minor vascular complications (G1: 12.8% vs. G2: 12.4%, p = 0.9). 30-day mortality was similar in both groups (G1: 6.4 ± 2.5% [95% CI: 0.88–0.98], G2: 3.7 ± 1.9% [95% CI: 0.92–0.99]. The Kaplan Meier analysis of survival revealed no significant differences either. Conclusion The difference in sheath diameter had no effect on either incidence or severity of vascular complications. There was no impact on mortality either.

Transcatheter Aortic Valve Implantation in Nonagenarians: Procedural Outcome and Mid-term Results

BACKGROUND For nonagenarians with symptomatic severe aortic stenosis transcatheter aortic valve implantation (TAVI) has become a feasible therapeutic option. Therefore, the aim of this study was to evaluate the procedural outcomes and mid-term follow-up in this patient group and compare this to octogenarians. METHODS From 1359 patients who underwent TAVI at our institution between March 2009 and February 2016, 82 patients were nonagenarians and 912 were octogenarians. In nonagenarians, mean age was 91.9±1.4years and compared to octogenarians showed a significantly higher logistic EuroScore (27.7±14.8% vs. 23.1±14.4, p=0.005) and STS Score (8.5±4.8% vs. 6.3±6.7, p=0.001). RESULTS There were no significant differences with regard to stroke rate, pacemaker implantation rate and major vascular complications between the two groups. Thirty-day mortality was 9.8% in nonagenarians and 4.1% in octogenarians (p=0.04). At 1 year, all-cause mortality increased to 30.9% vs. 18.6% (n.s.). CONCLUSION Nonagenarians showed an increased periprocedural mortality during TAVI and higher mortality in follow-up compared to octogenarians. Age alone is not a predictive factor but indication for treatment should be carefully evaluated by the heart team on an individual basis.

Preclinical determination of the best functional position for transcatheter heart valves implanted in rapid deployment bioprostheses

AIMS The aim of this study was to determine the best functional position of a transcatheter heart valve (THV) implanted as a valve-in-valve (ViV) procedure in small rapid deployment valves (RDV) in an in vitro model. METHODS AND RESULTS A 21 mm Perceval, Enable or INTUITY RDV was mounted into a pulse duplicator and a 23 mm balloon-expandable or a self-expanding THV was deployed (valve-in-valve) in two different positions. Under physiological hydrodynamic conditions, the performance of the THV was characterised by mean transvalvular pressure gradient (MPG), effective orifice area (EOA) and regurgitation volume (RV). Leaflet kinematics were assessed with high-speed video recordings, and X-ray images were acquired. All THV/RDV combinations met ISO requirements regarding hydrodynamic performance. In most cases, the higher position of the THV performed better than the lower one in terms of a lower MPG and increased EOA. Leaflet motion of the implanted THV was impaired in the lower position. In contrast, regurgitation volumes were relatively small and similar, regardless of the THV position. CONCLUSIONS ViV implantation of a THV in a small RDV yielded satisfactory hydrodynamic results. In most cases, a high implantation position achieved lower MPG, higher EOA and a reduced risk of impaired THV leaflet function. Fluoroscopy images of the best functional ViV positions are presented as a blueprint for patient procedures.

Valve-in-Valve Using an Edwards Sapien XT into a JenaValve in a Patient With a Low Originating Left Coronary Artery and a Heavily Calcified Aorta

Coronary obstruction during transcatheter aortic valve implantation is a potentially life‐threatening complication. Most of the widely used transcatheter heart valves require a certain distance between the basal aortic annular plane and the origins of the coronary arteries. We report the case of a successful valve‐in‐valve procedure with an Edwards SAPIEN XT valve into a JenaValve as a bail‐out procedure in a patient with a low originating left coronary artery and a heavily calcified aorta.

Aktueller Stand der kathetergestützten Aortenklappenimplantation

ZusammenfassungZur invasiven Therapie der symptomatischen hochgradigen Aortenklappenstenose hat sich die kathetergestützte Aortenklappenimplantation („transcatheter aortic valve implantation“, TAVI) bei ausgewählten Patienten als akzeptierte Alternative zum konventionellen Aortenklappenersatz (AKE) etabliert. Seit seiner Erstanwendung im Menschen 2002 wurde dieses Verfahren im Hinblick auf Patientenselektion, präoperative Diagnostik, Prothesendesigns und Implantationstechniken rasch weiterentwickelt. Aufgrund der guten Ergebnisse, die bislang erzielt wurden, wird eine Ausweitung der Indikation auf Patienten mit intermediärem Risiko diskutiert. Darüber hinaus wird, nicht unumstritten, von vielen Zentren eine „Transfemoral-first“-Strategie bevorzugt. Ziel dieses Beitrags ist es, einen Überblick über die aktuelle Praxis der TAVI zu geben und aktuelle Diskussionsthemen zusammenzufassen.AbstractFor selected patients, transcatheter aortic valve implantation (TAVI) has emerged as an accepted alternative to surgical aortic valve replacement for treatment of severe symptomatic aortic stenosis. The procedure has undergone a rapid evolvement since the first-in-man procedure in 2002. New devices have been introduced, implantation techniques modified and preoperative imaging modalities refined. Due to the favorable results achieved, the expansion of the indications for TAVI is the subject of current debate. Furthermore, a transfemoral-first approach is becoming favored more and more by many centers. The aim of this article is to give an update on current clinical practice and to summarize contemporary issues under debate.

Valve-in-valve transcatheter aortic valve implantation with CoreValve/Evolut R© for degenerated small versus bigger bioprostheses

OBJECTIVES We present our single center experience with Medtronic CoreValve and Evolut R regarding procedural outcome and 3 years follow-up in patients with degenerated bioprostheses. METHODS From 1645 patients who underwent transfemoral TAVI at our institution between February 2009 and December 2016, 37 patients with degenerated bioprosthesis were treated with Medtronic CoreValve/Evolut R. All data concerning baseline characteristic, procedural outcomes and follow-up were entered into a dedicated database. RESULTS Mean age was 83.9 ± 4.4 years and patients showed an average logistic EuroSCORE of 33.2 ± 16.7%. Successful ViV deployment was achieved in all cases, a permanent pacemaker was implanted in 16.2%, no periinterventional stroke and no coronary obstruction occurred. Mortality at 30 days was 2.7%, at 1-year follow-up 5.7% and at three years 13.5%. Depending on bioprosthesis size <23 mm versus ≥23 mm echocardiographic mean gradients post implantation were significantly higher in the smaller bioprostheses, 22.8 mmHg ± 9.4 mmHg versus 15.1 ± 7.1, P = 0.013. CONCLUSION ViV-TAVI with CoreValve/R is demonstrated to be safe and effective in terms of no coronary obstruction and very low mortality up to 3 years despite slightly higher mean transprosthetic gradients especially in very small bioprostheses.