Abstract
Aims
There are limited data on coronary obstruction following transcatheter valve-in-valve (ViV) implantation inside failed aortic bioprostheses. The objectives of this study were to ...determine the incidence, predictors, and clinical outcomes of coronary obstruction in transcatheter ViV procedures.
Methods and results
A total of 1612 aortic procedures from the Valve-in-Valve International Data (VIVID) Registry were evaluated. Data were subject to centralized blinded corelab computed tomography (CT) analysis in a subset of patients. The virtual transcatheter valve to coronary ostium distance (VTC) was determined. A total of 37 patients (2.3%) had clinically evident coronary obstruction. Baseline clinical characteristics in the coronary obstruction patients were similar to controls. Coronary obstruction was more common in stented bioprostheses with externally mounted leaflets or stentless bioprostheses than in stented with internally mounted leaflets bioprostheses (6.1% vs. 3.7% vs. 0.8%, respectively; P < 0.001). CT measurements were obtained in 20 (54%) and 90 (5.4%) of patients with and without coronary obstruction, respectively. VTC distance was shorter in coronary obstruction patients in relation to controls (3.24 ± 2.22 vs. 6.30 ± 2.34, respectively; P < 0.001). Using multivariable analysis, the use of a stentless or stented bioprosthesis with externally mounted leaflets odds ratio (OR): 7.67; 95% confidence interval (CI): 3.14–18.7; P < 0.001 associated with coronary obstruction for the global population. In a second model with CT data, a shorter VTC distance predicted this complication (OR: 0.22 per 1 mm increase; 95% CI: 0.09–0.51; P < 0.001), with an optimal cut-off level of 4 mm (area under the curve: 0.943; P < 0.001). Coronary obstruction was associated with a high 30-day mortality (52.9% vs. 3.9% in the controls, respectively; P < 0.001).
Conclusion
Coronary obstruction following aortic ViV procedures is a life-threatening complication that occurred more frequently in patients with prior stentless or stented bioprostheses with externally mounted leaflets and in those with a short VTC.
IMPORTANCE: Owing to a considerable shift toward bioprosthesis implantation rather than mechanical valves, it is expected that patients will increasingly present with degenerated bioprostheses in the ...next few years. Transcatheter aortic valve-in-valve implantation is a less invasive approach for patients with structural valve deterioration; however, a comprehensive evaluation of survival after the procedure has not yet been performed. OBJECTIVE: To determine the survival of patients after transcatheter valve-in-valve implantation inside failed surgical bioprosthetic valves. DESIGN, SETTING, AND PARTICIPANTS: Correlates for survival were evaluated using a multinational valve-in-valve registry that included 459 patients with degenerated bioprosthetic valves undergoing valve-in-valve implantation between 2007 and May 2013 in 55 centers (mean age, 77.6 SD, 9.8 years; 56% men; median Society of Thoracic Surgeons mortality prediction score, 9.8% interquartile range, 7.7%-16%). Surgical valves were classified as small (≤21 mm; 29.7%), intermediate (>21 and <25 mm; 39.3%), and large (≥25 mm; 31%). Implanted devices included both balloon- and self-expandable valves. MAIN OUTCOMES AND MEASURES: Survival, stroke, and New York Heart Association functional class. RESULTS: Modes of bioprosthesis failure were stenosis (n = 181 39.4%), regurgitation (n = 139 30.3%), and combined (n = 139 30.3%). The stenosis group had a higher percentage of small valves (37% vs 20.9% and 26.6% in the regurgitation and combined groups, respectively; P = .005). Within 1 month following valve-in-valve implantation, 35 (7.6%) patients died, 8 (1.7%) had major stroke, and 313 (92.6%) of surviving patients had good functional status (New York Heart Association class I/II). The overall 1-year Kaplan-Meier survival rate was 83.2% (95% CI, 80.8%-84.7%; 62 death events; 228 survivors). Patients in the stenosis group had worse 1-year survival (76.6%; 95% CI, 68.9%-83.1%; 34 deaths; 86 survivors) in comparison with the regurgitation group (91.2%; 95% CI, 85.7%-96.7%; 10 deaths; 76 survivors) and the combined group (83.9%; 95% CI, 76.8%-91%; 18 deaths; 66 survivors) (P = .01). Similarly, patients with small valves had worse 1-year survival (74.8% 95% CI, 66.2%-83.4%; 27 deaths; 57 survivors) vs with intermediate-sized valves (81.8%; 95% CI, 75.3%-88.3%; 26 deaths; 92 survivors) and with large valves (93.3%; 95% CI, 85.7%-96.7%; 7 deaths; 73 survivors) (P = .001). Factors associated with mortality within 1 year included having small surgical bioprosthesis (≤21 mm; hazard ratio, 2.04; 95% CI, 1.14-3.67; P = .02) and baseline stenosis (vs regurgitation; hazard ratio, 3.07; 95% CI, 1.33-7.08; P = .008). CONCLUSIONS AND RELEVANCE: In this registry of patients who underwent transcatheter valve-in-valve implantation for degenerated bioprosthetic aortic valves, overall 1-year survival was 83.2%. Survival was lower among patients with small bioprostheses and those with predominant surgical valve stenosis.
Abstract Objectives The purpose of this analysis was to assess 5-year outcomes of transcatheter aortic valve implantation (TAVI) using the current technology of the self-expanding CoreValve ...prosthesis (Medtronic Inc., Minneapolis, Minnesota). Background There is a paucity of evidence on long-term durability of currently available transcatheter heart valves. Methods Starting in June 2007, all consecutive patients with severe aortic stenosis undergoing TAVI with the third-generation 18-F CoreValve device in 8 Italian centers were prospectively included in the ClinicalService Project. For the purposes of this study, we included only consecutive patients with 5-year follow-up data available (n = 353) treated from June 2007 to August 2009. All outcomes were reported according to VARC (Valve Academic Research Consortium)-1 criteria. Results All-cause mortality rates at 1, 2, 3, 4, and 5 years were 21%, 29%, 38%, 48%, and 55.0%, respectively. Cardiovascular mortality rates at 1, 2, 3, 4, and 5 years were 10%, 14%, 19%, 23%, and 28.0%, respectively. The overall neurological event rate at 5 years was 7.5%, of which more than two-thirds occurred early after the procedure. During follow-up, there were 241 rehospitalizations for cardiovascular reasons in 164 (46%) patients. Among all rehospitalizations, acute heart failure was the most frequently reported (42.7%), followed by requirement of permanent pacemaker implantation (17.4%). On echocardiography, mean transaortic gradients decreased from 55.6 ± 16.8 mm Hg (pre-TAVI) to 12.8 ± 10.9 mm Hg (5-year post-TAVI) (p < 0.001). Late prosthesis failure occurred in 5 cases (1.4%); among these, redo TAVI was successfully carried out in 2 patients (0.6%) presenting with symptomatic prosthesis restenosis. The remaining 3 cases of prosthesis failure did not undergo further invasive interventions. Ten patients (2.8%) showed late mild stenosis with a mean transaortic gradient ranging from 20 to 40 mm Hg. No other cases of structural or nonstructural valvular deterioration were observed. Valve thrombosis or late valve embolization were not reported. Conclusions TAVI with the currently adopted CoreValve generation was associated with sustained clinical outcomes up to 5-year follow-up, with a low rate (1.4%) of significant prosthetic valve degeneration. The procedure appears to be an adequate and lasting resolution of aortic stenosis in selected high-risk patients.
The aim of this study was to assess coronary accessibility after transcatheter aortic valve replacement (TAVR)-in-TAVR using multidetector computed tomography.
Expanding TAVR to patients with longer ...life expectancy may involve more frequent bioprosthetic valve failure and need for redo TAVR. Coronary access after TAVR-in-TAVR may be challenging, particularly as the leaflets from the initial transcatheter heart valve (THV) will form a neo-skirt following TAVR-in-TAVR.
In 45 patients treated with different combinations of CoreValve and Evolut (CV/EV) THVs with supra-annular leaflet position and SAPIEN THVs with intra-annular leaflet position, post-TAVR-in-TAVR multidetector computed tomographic scans were analyzed to examine coronary accessibility.
After TAVR-in-TAVR, the coronary arteries originated below the top of the neo-skirt in 90% of CV/EV-first cases compared with 67% of SAPIEN-first cases (p = 0.009). For these coronary arteries originating below the top of the neo-skirt, the distance between the THV and the aortic wall was <3 mm in 56% and 25% of CV/EV-first and SAPIEN-first cases, respectively (p = 0.035). Coronary access may be further complicated by THV-THV stent frame strut misalignment in 53% of CV/EV-in-CV/EV cases. The risk for technically impossible coronary access was 27% and 10% in CV/EV-first and SAPIEN-first cases, respectively (p = 0.121). Absence of THV interference with coronary accessibility can be expected in 8% and 33% of CV/EV-first and SAPIEN-first cases, respectively (p = 0.005).
Coronary access after TAVR-in-TAVR may be challenging in a significant proportion of patients. THVs with intra-annular leaflet position or low commissural height and large open cells may be preferable in terms of coronary access after TAVR-in-TAVR.
The aim of this study was to determine whether the association of small label size of the surgical valve with increased mortality after transcatheter valve-in-valve (ViV) implantation is, at least in ...part, related to pre-existing prosthesis-patient mismatch (PPM) (i.e., a bioprosthesis that is too small in relation to body size).
Transcatheter ViV implantation is an alternative for the treatment of patients with degenerated bioprostheses. Small label size of the surgical valve has been associated with increased mortality after ViV implantation.
Data from 1,168 patients included in the VIVID (Valve-in-Valve International Data) registry were analyzed. Pre-existing PPM of the surgical valve was determined using a reference value of effective orifice area for each given model and size of implanted prosthetic valve indexed for body surface area. Severe PPM was defined according to the criteria proposed by the Valve Academic Research Consortium 2: indexed effective orifice area <0.65 cm2/m2 if body mass index is <30 kg/m2 and <0.6 cm2/m2 if BMI is ≥30 kg/m2. The primary study endpoint was 1-year mortality.
Among the 1,168 patients included in the registry, 89 (7.6%) had pre-existing severe PPM. Patients with severe PPM had higher 30-day (10.3%, p = 0.01) and 1-year (unadjusted: 28.6%, p < 0.001; adjusted: 19.3%, p = 0.03) mortality rates compared with patients with no severe PPM (4.3%, 11.9%, and 10.9%, respectively). After adjusting for surgical valve label size, Society of Thoracic Surgeons score, renal failure, diabetes, and stentless surgical valves, presence of pre-existing severe PPM was associated with increased risk for 1-year mortality (odds ratio: 1.88; 95% confidence interval: 1.07 to 3.28; p = 0.03). Patients with severe PPM also more frequently harbored high post-procedural gradients (mean gradient ≥20 mm Hg).
Pre-existing PPM of the failed surgical valve is strongly and independently associated with increased risk for mortality following ViV implantation.
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BACKGROUND—Transcatheter aortic valves can degenerate in a manner similar to surgical bioprostheses.
METHODS AND RESULTS—Clinical and echocardiographic outcomes of patients who underwent redo ...transcatheter aortic valve replacement (TAVR) procedures >2 weeks post procedure were collected from 14 centers. Among 13 876 patients, 50 (0.4%) underwent redo TAVR procedure at participating centers. Indications for redo TAVR were moderate–severe prosthetic aortic valve stenosis (n=10, 21.7%), moderate–severe central prosthetic aortic valve regurgitation (n=13, 28.3%), and moderate–severe paraprosthetic aortic valve regurgitation (n=25, 50.0%). The index TAVR was most commonly a Medtronic CoreValve (N=38, 76.0%), followed by Edwards SAPIEN-type valves (n=12, 24.0%) and Portico (n=1, 2.0%). The redo TAVR device was most commonly a CoreValve/Evolut R (n=29, 58.0%), followed by a SAPIEN-type valve (n=20,40.0%) or a Boston Lotus valve (n=1, 2.0%). In 40 patients (80.0%), redo TAVR was performed using the identical device type or that of the succeeding generation. Valve performance was uniformly good after redo TAVR (mean transvalvular gradient post redo TAVR12.5±6.1 mm Hg). At hospital discharge, all patients remained alive, with 1 nondisabling stroke (2.0%) and 1 life-threatening bleed (2.0%). Permanent pacemaker implantation was required in 3 out of 35 patients without a prior pacemaker (8.6%). Late survival was 85.1% at a median follow-up of 1589 days (range31–3775) after index TAVR and 635 days (range8–2460) after redo TAVR.
CONCLUSIONS—Redo TAVR for the treatment of postprocedural and late occurrence of paravalvular regurgitation and transcatheter aortic valve prosthesis failure seems to be safe, and it is associated with favorable acute and midterm clinical and echocardiographic outcomes.
No indication are available for transcatheter aortic valve implantation (TAVI) sizing in bicuspid aortic valve (BAV). Aim of the study is to develop and validate a Multi-Slice Computed Tomography ...(MSCT)-based algorithm for transcatheter heart valve (THV) sizing in patients with stenotic BAV under evaluation for TAVI.
A two steps method was applied: 1)evaluation of a cohort of 19 consecutive patients with type I BAV stenosis undergoing TAVI through pre and post-procedural MSCT, and development of an algorithm for THV sizing; 2)validation of the algorithm on a new cohort of 21 patients.
In the first cohort, a high correlation was found between the raphe-level area measured at pre-procedural MSCT and the smallest THV area measured at post-procedural MSCT (p < 0.001). Moreover, reduced THV expansion was observed among patients with higher calcium burden (p = 0.048). Then, a new algorithm for TAVI sizing in BAV was develop (CASPER: Calcium Algorithm Sizing for bicusPid Evaluation with Raphe). This algorithm is based on the reassessment of the perimeter/area derived annulus diameter, according to three main anatomical features: 1) the ratio between raphe length and annulus diameter; 2)calcium burden; 3)calcium distribution in relation to the raphe.
The algorithm was then validated in a new cohort of 21 patients, achieving 100% of procedural success and excellent TAVI performance.
MSCT assessment of raphe length, calcium burden and its distribution is of crucial relevance in the pre-procedural evaluation of patients with BAV. These anatomical features can be combined in a new and simple algorithm for TAVI sizing.
Objectives
Aim of this study is to evaluate safety, feasibility, and mid‐term outcome of transcatheter aortic valve implantation (TAVI) in cardiogenic shock (CS).
Background
Balloon aortic ...valvuloplasty in patients with severe aortic valve stenosis (SAS) complicated by CS is indicated but associated with a grim prognosis. TAVI might be a more reasonable treatment option in this setting but data are scant.
Methods
From March 2008 to February 2019, 51 patients with severe aortic valvulopathy (native SAS or degenerated aortic bioprosthesis) and CS treated by TAVI in 11 European centers were included in this multicenter registry. Demographic, clinical, and procedural data were collected, as well as clinical and echocardiographic follow‐up.
Results
The mean age of our study population was 75.8 ± 13, 49% were women, and mean Society of Thoracic Surgeons (STS) score was 19 ± 15%. Device success was achieved in 94.1%, with a 5% incidence of moderate/severe paravalvular leak. The 30‐day events were mortality 11.8%, stroke 2.0%, vascular complications 5.9%, and acute kidney injury 34%. Valve Academic Research Consortium‐2 early safety endpoint was reached in 35.3% of cases. At 1‐year of follow‐up, the mortality rate was 25.7% and the readmission for congestive heart failure was 8.6%.
Conclusions
TAVI seems to be a therapeutic option for patients with CS and SAS or degenerated aortic bioprosthesis in terms of both safety and efficacy at early and long‐term follow‐up.
The aim of this multicentre study is to report the clinical experiences of all patients undergoing transcatheter aortic valve implantation (TAVI) with a balloon-expandable device in Italy.
The ...Italian Transcatheter balloon-Expandable valve Registry (ITER) is a real-world registry that includes patients who have undergone TAVI with the Sapien (Edwards Lifesciences, Irvine, CA, USA) bioprosthesis in Italy since it became available in clinical practice. From 2007 to 2012, 1904 patients were enrolled to undergo TAVI in 33 Italian centres. Outcomes were classified according to the updated Valve Academic Research Consortium (VARC-2) definitions. A multivariable analysis was performed to identify independent predictors of all-cause mortality.
Mean age was 81.7 (SD:6.2) years, and 1147 (60.2%) patients were female. Mean Logistic EuroSCORE was 21.1% (SD:13.7). Transfemoral, transapical, transaortic and transaxillary TAVI was performed in 1252 (65.8%), 630 (33.1%), 18 (0.9%) and 4 (0.2%) patients, respectively. Operative mortality was 7.2% (137 patients). The VARC-2 outcomes were as follows: device success, 88.1%; disabling stroke, 1.0%; life-threatening and major bleeding 9.8 and 10.5%, respectively; major vascular complication, 9.7%; acute kidney injury, 8.2%; acute myocardial infarction ≤72 h, 1.5%. Perioperative pacemaker implantation was necessary in 116 (6.1%) patients. At discharge, the mean transprosthetic gradient was 10.7 (SD:4.5) mmHg. Incidence of postoperative mild, moderate or severe paravalvular leak was, respectively, 32.1, 5.0 and 0.4%. A total of 444/1767 (25.1%) deaths after hospital discharge were reported: of these, 168 (37.8%) were classified as cardiac death. Preoperative independent predictors of all-cause mortality were male gender (HR: 1.395; 95% CI:1.052-1.849); overweight, BMI 25-30 kg/m
(HR: 0.775; 95% CI: 0.616-0.974); serum creatinine level (every 1 mg/dl increase; HR: 1.314; 95% CI:1.167-1.480); haemoglobin level (every 1 g/dl increase; HR: 0.905; 95% CI:0.833-0.984); critical preoperative state (HR: 2.282; 95% CI: 1.384-3.761); neurological dysfunction (HR: 1.552; 95% CI:1.060-2.272); atrial fibrillation (HR: 1.556; 95% CI:1.213-1.995); pacemaker rhythm (HR: 1.948; 95% CI:1.310-2.896); NYHA Class III or IV (HR: 1.800; 95% CI:1.205-2.689 or HR: 2.331; 95% CI:1.392-3.903, respectively).
TAVI with a balloon-expandable device in the 'real world' shows good mid-term outcomes in terms of survival, technical success, valve-related adverse events and haemodynamic performance.
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