Buntaro Fujita

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.

Anaortic off-pump versus clampless off-pump using the PAS-Port device versus conventional coronary artery bypass grafting: mid-term results from a matched propensity score analysis of 5422 unselected patients

OBJECTIVES Meta‐analyses from observational and randomized studies have demonstrated benefits of off‐pump surgery for hard and surrogate endpoints. In some of them, increased re‐revascularization was noted in the off‐pump groups, which could impact their long‐term survival. Therefore, we analyzed the course of all patients undergoing isolated coronary surgery regarding the major cardiac and cerebrovascular event (MACCE) criteria. METHODS A prospective register was taken from a high‐volume off‐pump center recording all anaortic off‐pump (ANA), clampless off‐pump (PAS‐Port) and conventional (CONV) coronary artery bypass operations between July 2009 and June 2015. Propensity Score Matching was performed based on 28 preoperative risk variables. RESULTS We identified 935 triplets (N = 2805). Compared with CONV, in‐hospital mortality of both the ANA group (OR for ANA [95% CI] 0.25 [0.06; 0.83], P = 0.021), and the PAS‐Port group was lower (OR for PAS‐Port [95% CI] 0.50 [0.17; 1.32], P = 0.17). In the mid‐term follow‐up there were no significant differences between the groups regarding mortality (HR for ANA [95%‐CI] 0.83 [0.55‐1.26], P = 0.38; HR for PAS‐Port [95%‐CI] 1.06 [0.70‐1.59], P = 0.79), incidence of stroke (HR for ANA 0.81 [0.43‐1.53], P = 0.52; HR for PAS‐Port 0.78 [0.41‐1.50], P = 0.46), myocardial infarction (HR for ANA 0.53 [0.22‐1.31], P = 0.17; HR for PAS‐Port 0.78 [0.37‐1.66], P = 0.52) or re‐revascularization rate (HR for ANA 0.99 [0.67‐1.44], P = 0.94; HR for PAS‐Port 0.95 [0.65‐1.38], P = 0.77). CONCLUSIONS Both off‐pump clampless techniques were associated with lower in‐hospital mortality compared with conventional CABG. The mid‐term course showed no difference with regard to the MACCE criteria between anaortic off‐pump, clampless off‐pump using PAS‐Port and conventional CABG.

Dual source computed tomography based analysis of stent performance, its association with valvular calcification and residual aortic regurgitation after implantation of a balloon-expandable transcatheter heart valve

Objectives The aim of this study was to investigate the mutual influence of valvular calcifications and transcatheter aortic valve stent geometry during and after implantation of a balloon-expandable SAPIEN ® /SAPIEN XT ® prostheses. Aortic valve calcification has been linked with adverse complications after transcatheter aortic valve implantation (TAVI). However, little is known about the fate of the calcifications after TAVI as well as its influence on transcatheter heart valve geometry. Methods Thirty one patients underwent cardiac dual source computed tomography (DSCT) before and after a TAVI with the Edwards SAPIEN/SAPIEN XT ® prostheses. Detailed DSCT image analysis was performed with Mimics ® and 3Matic ® (both Materialise, Leuven, Belgium). Results Implanted stents reached an average degree of expansion of 84% and achieved good circularity despite the presence of fairly oval native annuli and a heterogeneous degree of valvular calcification. Both, the degree of stent expansion and the degree of stent eccentricity were inversely related to the degree of oversizing, but independent of the degree of valvular calcification and native annular ovality. Visualization of the position of calcific debris before and after TAVI showed that calcifications were shifted upwards and outwards as a consequence of the implantation procedure. The degree of stent eccentricity was related to residual aortic regurgitation grade ≥2. Conclusions The SAPIEN ® /SAPIEN XT ® prostheses achieved good degrees of stent expansion and circularity regardless of the morphology of the landing zone. Increased stent ovality was associated with an elevated risk for aortic regurgitation. The total calcification volume, degree of annular ovality and stent expansion were not associated with residual AR.

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.

Myocardial tissue engineering strategies for heart repair: current state of the art

The current state-of-the-art treatment for heart failure patients is aimed at delaying disease progression, relieving symptoms, reducing morbidity and improving survival. Cardiac regeneration of the injured heart, however, is not achieved. Currently, numerous alternative treatment approaches aiming at cardiac regeneration are under investigation. Myocardial tissue engineering strategies follow the idea of in vitro generation of myocardium-like structures for epicardial transplantation. Recently, this field has made tremendous advances regarding in vitro optimization of tissue-engineered constructs, and valuable data have been generated in small animal models. This review summarizes the technical aspects of engineered human myocardium generation, lessons learned from preclinical in vitro and in vivo studies and the current state of this approach on its way to clinical translation.

Predictors of failure after high urgent listing for a heart transplant

OBJECTIVES As waiting times for a heart transplant (HTx) increase, the decision of whether a patient should have a high urgent (HU) listing or mechanical circulatory support becomes crucial for further prognosis. The aim of this study was to determine the characteristics that predict failure of an HU listing (death/delisting due to urgent mechanical circulatory support implant or poor clinical condition), the 5-year survival rate, the 1-year post-transplant survival rate and the prognostic accuracy of the cardiac allocation score of patients on the HU list. METHODS A total of 447 patients who were on the HU list at our institution between 2005 and 2016 were analysed and stratified according to occurrence of therapy failure or reception of an HTx. RESULTS A total of 114 patients suffered from HU listing failure after a median HU time of 31.5 (15-69) days; 320 patients had a primary HTx after a median time of 51.5 (26-90) days on the HU list; 13 patients were excluded from data analysis because of an ongoing HU listing or delisting due to improvement in their haemodynamic condition. In multivariable logistic regression analysis, blood group 0 [odds ratio (OR) 2.48, 95% confidence interval (CI) 1.43-4.3; P = 0.001], INTERMACS Class 1 or 2 (OR 5.1, 95% CI 2.7-9.4; P < 0.001), vasoactive inotropic score (OR 1.18, 95% CI 1.09-1.27; P < 0.001) and brain natriuretic peptide levels (OR 1.00, 95% CI 1.00-1.00; P = 0.001) were identified as independent predictors of HU listing failure. Cardiac allocation score was not independently associated with listing failure. Estimated 5-year and 1-year post-HTx survival rates were similar in the primary HTx group and in patients receiving an HTx after HU therapy failure (P = 0.48 and P = 0.7, respectively). CONCLUSIONS INTERMACS levels 1 and 2 and vasoactive inotropic score were the strongest predictors of HU listing failure.

Outcomes of transcatheter mitral valve replacement for degenerated bioprostheses, failed annuloplasty rings, and mitral annular calcification

Aims We sought to evaluate the outcomes of transcatheter mitral valve replacement (TMVR) for patients with degenerated bioprostheses [valve-in-valve (ViV)], failed annuloplasty rings [valve-in-ring (ViR)], and severe mitral annular calcification [valve-in-mitral annular calcification (ViMAC)]. Methods and results From the TMVR multicentre registry, procedural and clinical outcomes of ViV, ViR, and ViMAC were compared according to Mitral Valve Academic Research Consortium (MVARC) criteria. A total of 521 patients with mean Society of Thoracic Surgeons score of 9.0 ± 7.0% underwent TMVR (322 patients with ViV, 141 with ViR, and 58 with ViMAC). Trans-septal access and the Sapien valves were used in 39.5% and 90.0%, respectively. Overall technical success was excellent at 87.1%. However, left ventricular outflow tract obstruction occurred more frequently after ViMAC compared with ViR and ViV (39.7% vs. 5.0% vs. 2.2%; P < 0.001), whereas second valve implantation was more frequent in ViR compared with ViMAC and ViV (12.1% vs. 5.2% vs. 2.5%; P < 0.001). Accordingly, technical success rate was higher after ViV compared with ViR and ViMAC (94.4% vs. 80.9% vs. 62.1%; P < 0.001). Compared with ViMAC and ViV groups, ViR group had more frequent post-procedural mitral regurgitation ≥moderate (18.4% vs. 13.8% vs. 5.6%; P < 0.001) and subsequent paravalvular leak closure (7.8% vs. 0.0% vs. 2.2%; P = 0.006). All-cause mortality was higher after ViMAC compared with ViR and ViV at 30 days (34.5% vs. 9.9% vs. 6.2%; log-rank P < 0.001) and 1 year (62.8% vs. 30.6% vs. 14.0%; log-rank P < 0.001). On multivariable analysis, patients with failed annuloplasty rings and severe MAC were at increased risk of mortality after TMVR [ViR vs. ViV, hazard ratio (HR) 1.99, 95% confidence interval (CI) 1.27-3.12; P = 0.003; ViMAC vs. ViV, HR 5.29, 95% CI 3.29-8.51; P < 0.001]. Conclusion The TMVR provided excellent outcomes for patients with degenerated bioprostheses despite high surgical risk. However, ViR and ViMAC were associated with higher rates of adverse events and mid-term mortality compared with ViV.