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.
To determine the survival of patients after transcatheter valve-in-valve implantation inside failed surgical bioprosthetic valves.
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.
Survival, stroke, and New York Heart Association functional class.
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).
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.
Objectives This study sought to collect data and evaluate the anecdotal use of transcatheter aortic valve implantation (TAVI) in pure native aortic valve regurgitation (NAVR) for patients who were ...deemed surgically inoperable Background Data and experience with TAVI in the treatment of patients with pure severe NAVR are limited. Methods Data on baseline patient characteristics, device and procedure parameters, echocardiographic parameters, and outcomes up to July 2012 were collected retrospectively from 14 centers that have performed TAVI for NAVR. Results A total of 43 patients underwent TAVI with the CoreValve prosthesis (Medtronic, Minneapolis, Minnesota) at 14 centers (mean age, 75.3 ± 8.8 years; 53% female; mean logistic EuroSCORE (European System for Cardiac Operative Risk Evaluation), 26.9 ± 17.9%; and mean Society of Thoracic Surgeons score, 10.2 ± 5.3%). All patients had severe NAVR on echocardiography without aortic stenosis and 17 patients (39.5%) had the degree of aortic valvular calcification documented on CT or echocardiography. Vascular access was transfemoral (n = 35), subclavian (n = 4), direct aortic (n = 3), and carotid (n = 1). Implantation of a TAVI was performed in 42 patients (97.7%), and 8 patients (18.6%) required a second valve during the index procedure for residual aortic regurgitation. In all patients requiring second valves, valvular calcification was absent (p = 0.014). Post-procedure aortic regurgitation grade I or lower was present in 34 patients (79.1%). At 30 days, the major stroke incidence was 4.7%, and the all-cause mortality rate was 9.3%. At 12 months, the all-cause mortality rate was 21.4% (6 of 28 patients). Conclusions This registry analysis demonstrates the feasibility and potential procedure difficulties when using TAVI for severe NAVR. Acceptable results may be achieved in carefully selected patients who are deemed too high risk for conventional surgery, but the possibility of requiring 2 valves and leaving residual aortic regurgitation remain important considerations.
Valve thrombosis has yet to be fully evaluated after transcatheter aortic valve implantation. This study aimed to report the prevalence, timing, and treatment of transcatheter heart valve (THV) ...thrombosis.
THV thrombosis was defined as follows (1) THV dysfunction secondary to thrombosis diagnosed based on response to anticoagulation therapy, imaging modality or histopathology findings, or (2) mobile mass detected on THV suspicious of thrombus, irrespective of dysfunction and in absence of infection. Between January 2008 and September 2013, 26 (0.61%) THV thromboses were reported out of 4266 patients undergoing transcatheter aortic valve implantation in 12 centers. Of the 26 cases detected, 20 were detected in the Edwards Sapien/Sapien XT cohort and 6 in the Medtronic CoreValve cohort. In patients diagnosed with THV thrombosis, the median time to THV thrombosis post-transcatheter aortic valve implantation was 181 days (interquartile range, 45-313). The most common clinical presentation was exertional dyspnea (n=17; 65%), whereas 8 (31%) patients had no worsening symptoms. Echocardiographic findings included a markedly elevated mean aortic valve pressure gradient (40.5±14.0 mm Hg), presence of thickened leaflets or thrombotic apposition of leaflets in 20 (77%) and a thrombotic mass on the leaflets in the remaining 6 (23%) patients. In 23 (88%) patients, anticoagulation resulted in a significant decrease of the aortic valve pressure gradient within 2 months.
THV thrombosis is a rare phenomenon that was detected within the first 2 years after transcatheter aortic valve implantation and usually presented with dyspnea and increased gradients. Anticoagulation seems to have been effective and should be considered even in patients without visible thrombus on echocardiography.
To describe the procedural performance and 30-day outcomes following implantation using the 18 Fr CoreValve Revalving System (CRS) as part of the multicentre, expanded evaluation registry, 1-year ...after obtaining CE mark approval.
Patients with symptomatic severe aortic stenosis and logistic Euroscore > or =15%, or age > or =75 years, or age > or =65 years associated with pre-defined risk factors, and for whom a physician proctor and a clinical specialist were in attendance during the implantation and who collected the clinical data, were included. From April 2007, to April 2008, 646 patients with a mean age of 81 +/- 6.6 years, mean aortic valve area 0.6 +/- 0.2 cm2, and logistic EuroSCORE of 23.1 +/- 13.8% were recruited. After valve implantation, the mean transaortic valve gradient decreased from 49.4 +/- 13.9 to 3 +/- 2 mmHg. All patients had paravalvular aortic regurgitation < or = grade 2. The rate of procedural success was 97%. The procedural mortality rate was 1.5%. At 30 days, the all-cause mortality rate (i.e, including procedural) was 8% and the combined rate of death, stroke and myocardial infarction was 9.3%.
The results of this study demonstrate the high rate of procedural success and a low 30-day mortality in a large cohort of high-risk patients undergoing transcatheter aortic valve implantation (TAVI) with the CRS.
Transcatheter aortic valve-in-valve implantation is an emerging therapeutic alternative for patients with a failed surgical bioprosthesis and may obviate the need for reoperation. We evaluated the ...clinical results of this technique using a large, worldwide registry.
The Global Valve-in-Valve Registry included 202 patients with degenerated bioprosthetic valves (aged 77.7±10.4 years; 52.5% men) from 38 cardiac centers. Bioprosthesis mode of failure was stenosis (n=85; 42%), regurgitation (n=68; 34%), or combined stenosis and regurgitation (n=49; 24%). Implanted devices included CoreValve (n=124) and Edwards SAPIEN (n=78). Procedural success was achieved in 93.1% of cases. Adverse procedural outcomes included initial device malposition in 15.3% of cases and ostial coronary obstruction in 3.5%. After the procedure, valve maximum/mean gradients were 28.4±14.1/15.9±8.6 mm Hg, and 95% of patients had ≤+1 degree of aortic regurgitation. At 30-day follow-up, all-cause mortality was 8.4%, and 84.1% of patients were at New York Heart Association functional class I/II. One-year follow-up was obtained in 87 patients, with 85.8% survival of treated patients.
The valve-in-valve procedure is clinically effective in the vast majority of patients with degenerated bioprosthetic valves. Safety and efficacy concerns include device malposition, ostial coronary obstruction, and high gradients after the procedure.
Aims
Patients with bicuspid valves represent a challenging anatomical subgroup for transcatheter aortic valve implantation (TAVI). This analysis evaluated the clinical outcomes of the fully ...repositionable and retrievable Lotus Valve System in patients with bicuspid aortic valves enrolled in the RESPOND post‐market registry.
Methods and Results
The prospective, open‐label RESPOND study enrolled 1,014 patients at 41 centers in Europe, New Zealand, and Latin America, 31 (3.1%) of whom had bicuspid aortic valves. The mean age in the bicuspid patient cohort was 76.4 years, 64.5% were male, and the baseline STS score was 6.0 ± 10.2. Procedural success was 100%, with no cases of malpositioning, valve migration, embolization, or valve‐in‐valve. Repositioning was attempted in 10 cases (32.3%). There was one death (3.2%) and one stroke (3.2%) at 30‐day follow‐up. Mean AV gradient was reduced from 48.7 ± 17.0 mmHg at baseline to 11.8 ± 5.1 mmHg at hospital discharge (P < 0.001); mean effective orifice area (EOA) was increased from 0.6 ± 0.2 cm2 to 1.7 ± 0.4 cm2 (P < 0.001). There were no cases of moderate or severe paravalvular leak (PVL) adjudicated by the core laboratory; four subjects (13.8%) had mild PVL, 5 (17.2%) had trace PVL. The rate of pacemaker (PM) implantation for PM‐naïve patients was 22.2% (6/27).
Conclusions
Data from the RESPOND registry demonstrate good clinical and echocardiographic outcomes up to 1 year postimplantation in patients with bicuspid aortic valves using the repositionable Lotus Valve.
Objective: Trans-catheter aortic valve implantation (TAVI) technology is rapidly evolving, with 412 procedures having been performed at our institution. Herein, we report a complete, prospective ...analysis of complications occurring during transvascular and trans-apical implantations with two different prostheses. Methods: Between June 2007 and June 2010, 412 patients (258 female, mean age 80.3 ± 7.2 years, logistic EuroSCORE (European System for Cardiac Operative Risk Evaluation) 20.2% ± 13.0%) underwent TAVI through either a retrograde (n = 252 transfemoral, n = 28 transaxillary, and n = 5 transaortic) or antegrade (n = 127 trans-apical) approach at our institution. The trans-apical access was chosen only in cases where transvascular implantation was not possible. As many as 283 CoreValve and 129 Edwards Sapien prostheses were implanted. Results: Thirty-day survival was 90.9%. Vascular complications occurred in 42 patients (10.2%). In four patients, lethal aortic root (n = 3) or abdominal (n = 1) aortic rupture occurred. Pericardial effusion developed in 53 patients (12.8%), which resulted in cardiac tamponade in 12 patients (2.9%). Twenty-three patients (5.6%) with valve malplacement were treated interventionally. In five patients (1.2%), emergency institution of cardiopulmonary bypass was required during the procedure for temporary support; all patients survived. Seventeen patients underwent re-intervention on the catheter valve (4.1%). Conclusions: With growing experience, complications with TAVI may be avoided by proper patient selection and skillful management. Other complications, when they occur, require a specific treatment algorithm to avoid delay in decision making. A considerable number of complications after TAVI require surgical treatment. Therefore, the ideal environment for TAVI procedures is a hybrid operating room, where a multidisciplinary team of surgeons, cardiologists, and anesthesiologists is best fitted to meet the current needs associated with TAVI technology. A reduction in complications was seen after 300 cases. This finding attests to the complexity of the procedure in addition to the experience required to reduce the incidence of complications.
Objective: Transcatheter aortic valve implantation has been performed by several groups, most of them either specializing on the transapical (surgeons) or the percutaneous femoral transarterial ...approach (cardiologists). We achieved both transapical and percutaneous transcatheter valve implantation by a surgical team in a hybrid suite. Methods: Since June 2007, 137 patients (n = 78 female, mean age 81 ± 7 years) underwent transcatheter aortic valve implantation (n = 109 transfemoral, n = 3 via subclavian artery, n = 2 directly through ascending aorta, n = 23 transapical) with the CoreValve (n = 114) or the Edwards Sapien (n = 23) prosthesis. Results: Thirty-day mortality was 12.4% in this patient cohort. One hundred and eight patients (78.8%) are alive at a mean follow-up of 97 ± 82 days. Pacemaker implantation due to postoperative AV block was performed in 27 patients (19.7%), and 7 patients (5.1%) sustained neurological events. Patients improved in NYHA class (from 3.1 ± 0.3 to 1.9 ± 0.5, p < 0.001) and in self-assessed health state (from 55 ± 17% to 68 ± 16%, p < 0.001) at one-month follow-up. Echocardiographic assessment revealed excellent hemodynamic function of the prostheses with a mean aortic gradient (MAG) of 11.9 ± 4.4 mmHg and an effective orifice area (EOA) of 1.6 ± 0.4 cm2 at discharge and a MAG of 11.0 ± 4.2 mmHg and an EOA of 1.6 ± 0.3 cm2 at six months FU. Conclusions: Transcatheter aortic valve implantation has become an alternative technique for the treatment of aortic stenosis with reasonable short- and mid-term results at our institution. With the opportunity to treat aortic stenosis by conventional surgical valve replacement and transapical and percutaneous transcatheter procedures, the technique of lowest risk for the individual patient can be chosen and performed by one team.
The authors present the UK and Irish real-world learning curve experience of the Evolut R transcatheter heart valve.
The Evolut R is a self-expanding, repositionable, and fully recapturable ...second-generation transcatheter heart valve with several novel design features to improve outcomes and reduce complications.
Clinical, procedural, and 30-day outcome data were prospectively collected for the first 264 patients to receive the Evolut R valve in the United Kingdom and Ireland.
A total of 264 consecutive Evolut R implantations were performed across 9 centers. The mean age was 81.1 ± 7.8 years, and the mean logistic European System for Cardiac Operative Risk Evaluation score was 19.9 ± 13.7%. Procedural indications included aortic stenosis (72.0%), mixed aortic valve disease (17.4%), and failing aortic valve bioprostheses (10.6%). Conscious sedation was used in 39.8% of patients and transfemoral access in 93.6%. The procedural success rate was 91.3%, and paravalvular leak immediately after implantation was mild or less in 92.3%. Major complications were rare: cardiac tamponade in 0.4%, conversion to sternotomy in 0.8%, annular rupture in 0.0%, coronary occlusion in 0.8%, major vascular in 5.3%, acute kidney injury in 6.1%, new permanent pacemaker implantation in 14.7%, and procedure-related death in 0.0%. At 30-day follow-up, survival was 97.7%, paravalvular leak was mild or less in 92.3%, and the stroke rate was 3.8%.
This registry represents the largest published real-world experience of the Evolut R valve. The procedural success rate was high and safety was excellent, comparable with previous studies of the Evolut R valve and other second-generation devices. The low rate of complications represents an improvement on first-generation devices.
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