Transcatheter aortic valve replacement for degenerative bioprosthetic surgical valves: results from the global valve-in-valve registry.

BACKGROUND: 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. METHODS AND RESULTS: 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. CONCLUSIONS: 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.

Contemporary surgical or percutaneous management of severe aortic stenosis in the elderly.

AIMS: To assess patient characteristics, therapeutic options, and their results in patients referred to a tertiary centre with on-site capabilities for surgical and percutaneous valvular interventions for the management of severe symptomatic aortic stenosis (AS). METHODS AND RESULTS: Sixty-six consecutive patients >70 years (83 +/- 6 years) were referred for severe AS. Their mortality risk predicted by the logistic European System for Cardiac Operative Risk Evaluation and the Society of Thoracic Surgeons-Predicted Risk of Mortality scores were on average 20 +/- 14% and 17 +/- 7%, respectively. Thirty-nine patients (59%) were considered at high-risk for surgery or inoperable after multidisciplinary evaluation: 12 (31%) underwent a transfemoral aortic valve implantation and 27 were considered unsuitable and treated medically (n = 16) or with valvuloplasty (n = 7), or were re-directed towards surgery (n = 4). The 27 other patients underwent valve replacement. In-hospital mortality was 9% (6 of 66). There were three hospital deaths in patients treated percutaneously, two in those treated medically, and one after surgery. At 6 months, 10% (6 of 60) of the survivors died: two after valvuloplasty and four after medical treatment. CONCLUSION: A large proportion of elderly patients referred for management of severe AS have a high-risk profile. The availability of percutaneous valvular interventions increases the number of those who are offered interventions.

Comparison of hospital mortality during ST-segment elevation myocardial infarction in the era of reperfusion therapy in women versus men and in older versus younger patients.

There is intense interest in examining hospital mortality in relation to gender in ST-segment elevation myocardial infarction. The aim of the present study was to determine whether gender influences outcomes in men and women treated with the same patency-oriented reperfusion strategy. The influence of gender on hospital mortality was tested using multivariate analysis and local regression. The influence of age was tested as a continuous and as a categorical variable. In the overall population of 2,600 consecutive patients, gender was not correlated with hospital mortality except in the subgroup of women aged ≥65 years. The risk for death increased linearly in logit scale for men. Up to the age of 65 years, the risk also increased linearly in women but thereafter increased faster than in men. Testing age as a categorical variable, hospital mortality was higher in women than in men aged ≥75 years but was similar between the genders in the younger age categories. In conclusion, despite following an equal patency-oriented management strategy in men and women with ST-segment elevation myocardial infarctions, the risk for hospital death increased linearly with age but with an interaction between age and gender such that older women had an independent increase in hospital mortality. Longer time to presentation and worse baseline characteristics probably contributed to determine a high-risk subset but reinforce the need to apply, as recommended in the international guidelines in the management of patients with ST-segment elevation myocardial infarctions, the same strategy of acute reperfusion in men and women.

Transcatheter valve-in-ring implantation after failure of surgical mitral repair.

OBJECTIVES: Redo surgery after failed mitral valve repair may be high risk, or contraindicated in patients with comorbidities. Because of this high risk, other interventional possibilities like transcatheter valve implantation might be of benefit. We report our experience with transcatheter mitral valve-in-ring implantation (TVIR) in high-risk patients after failure of surgical ring annuloplasty. METHODS: From January 2010 to February 2012, following a multidisciplinary discussion, 17 high-risk patients underwent TVIR using Edwards SAPIEN XT prostheses, via either a transvenous transseptal (n = 8), or a transapical approach (n = 9). RESULTS: Patients were aged 70 ± 16 years, in New York Association classes III/IV. Their mean logistic EuroSCORE was 36 ± 17% and mean Society of Thoracic Surgeons risk score 13 ± 9%. The mean time interval between surgery and repair failure was 7 ± 3 years. Annuloplasty rings were semi-rigid in 14 cases, flexible in 2, and rigid in 1. Manufacturers ring diameters were 26 mm in 4 patients, 27 mm in 1, 28 mm in 9, 30 mm, 31 mm and 34 mm in 1. The predominant failure mode was regurgitation in 12 cases and stenosis in 5. SAPIEN XT diameters were 26 mm in 15 patients, 23 mm and 29 mm in 1. Procedural success rate was 88% (15/17). Emergency surgery was needed in 1 patient due to acute dislodgement of the ring. The degree of mitral regurgitation was reduced to none or mild in all but 2 patients; final mean gradient was 7 ± 3 mmHg. Thirty-day survival was 82% (14/17 patients). At last follow-up (13 ± 5 months), survival rate was 71% (12/17). CONCLUSIONS: These preliminary results suggest that TVIR is feasible, with low operative risk, and may provide short-term clinical and haemodynamic improvement in selected high-risk patients with failure of mitral ring annuloplasty.

Stent implantation in aorto-ostial lesions: long-term follow-up and predictors of outcome.

AIMS: To compare the outcomes of drug-eluting (DES) vs. bare-metal (BMS) stents for stenting of native aorto-ostial lesions (AOL) and to identify predictors of major adverse cardio and cerebrovascular events (MACCE). METHODS AND RESULTS: A total of 181 patients (182 AOL) who underwent stenting of AOL were retrospectively identified: right-coronary artery in 130 (71.4%), left main in 52 (28.6%). In-hospital event rate was 1.1% (two non-Q-wave myocardial infarctions). Follow-up was possible in 98.3%, median time=23.9 months (IQR 12.1-37.7). Event rates and survival MACCE-free were not significantly different between DES and BMS. After multivariate analysis, only the logistic EuroSCORE >10% predicted MACCE (HR=4.66, 95% CI: 2.38-9.12, p<0.001), whereas the predictors for TLR were age (HR=0.96, 95% CI: 0.92-1.00, p=0.039) and the stented artery (RCA vs. LM, HR=10.2, 95% CI: 1.37-75.45, p=0.024). CONCLUSIONS: AOL stenting can be performed with high success and low complication rates. At follow-up, no significant differences in event rates were found between DES and BMS; EuroSCORE>10% was the only predictor of MACCE.

Multicenter evaluation of Edwards SAPIEN positioning during transcatheter aortic valve implantation with correlates for device movement during final deployment.

OBJECTIVES: This study sought to evaluate the exact location of Edwards SAPIEN (Edwards Lifesciences, Irvine, California) devices in different stages of implantation and to quantify possible operator-independent device movement during final deployment. BACKGROUND: Accurate device positioning during transcatheter aortic valve implantation is crucial in order to achieve optimal results. METHODS: This multicenter study consisted of 68 procedures with reliable pacemaker capture. Device positions were assessed using fluoroscopic images and the C-THV system (Paieon Medical, Rosh Ha'Ayin, Israel). RESULTS: The location after implantation was significantly higher than in the final stage of rapid pacing: 16.7 ± 16.3% of device height below the plane of the lower sinus border versus 32.6 ± 13.8%, p < 0.0001. Operator-independent device-center upper movement during final deployment was 2 ± 1.43 mm, range: -1.3 to 4.6 mm. Device movement was asymmetrical, occurring more in the lower part of the device than in its upper part (3.2 ± 1.4 mm vs. 0.75 ± 1.5 mm, p < 0.001), resulting in device shortening. Multivariate analysis revealed that moderate and severe aortic valve calcification had 49% higher upward movement than mild calcification (p = 0.03), and aortic sinus volume was negatively correlated with movement size (r = -0.35, p = 0.005). This movement was independent of device version (SAPIEN vs. SAPIEN XT), procedural access (transfemoral vs. transapical), and interventricular septum width. CONCLUSIONS: The final Edwards SAPIEN position is mostly aortic in relation to the lower sinus border. There is an operator-independent upward movement of the device center during the final stage of implantation. Anticipated upward movement of the device should influence its positioning before final deployment.

Early and mid-term outcomes in patients undergoing transcatheter aortic valve implantation after previous coronary artery bypass grafting.

OBJECTIVES: Surgical aortic valve replacement in patients with previous coronary artery bypass grafting (CABG) carries a high mortality. Transcatheter aortic valve implantation (TAVI) has been shown to be successful in high risk subgroups of patients. Our goal is therefore to evaluate the impact of a history of CABG on the outcome of patients who undergo TAVI. METHODS: From October 2006 to June 2010, among the 201 patients selected to undergo TAVI, 54 (27%) had a history of CABG. Outcomes were prospectively collected. RESULTS: The 30-day outcome was not different between patients with previous CABG vs. those without, in particular as regards mortality (respectively, 5.6% vs. 10.9%; P = 0.25). Mid-term survival (mean FU: 7 ± 9 months) was not different at 2 years between patients with previous CABG vs. patients without (65.7 ± 6.2% vs. 80.0 ± 7.7% respectively; P = 0.12). In multivariate analysis, CABG was not associated with an excess mid-term mortality after TAVI. CONCLUSIONS: Previous CABG does not adversely affect outcome in patients undergoing TAVI. If confirmed by larger prospective series and ideally by a randomized trial comparing CABG vs. redo surgery, this observation might lead the heart team to consider TAVI as an attractive option in the population of high risk patients with aortic stenosis and previous CABG.

Feasibility and outcomes of transcatheter aortic valve implantation in high-risk patients with stenotic bicuspid aortic valves.

Little is known about transcatheter aortic valve implantation (TAVI) in patients with bicuspid aortic valve stenosis, which usually represents a contraindication. The aim of this study was to assess the feasibility and the results of TAVI in this patient subset. Of 316 high-risk patients with severe aortic stenosis who underwent TAVI from January 2009 to January 2012, 15 (5%) had documented bicuspid aortic valves. They were treated using a transarterial approach, using the Medtronic CoreValve system. Patients were aged 80 ± 10 years, in New York Heart Association functional classes III and IV. The mean aortic valve area was 0.8 ± 0.3 cm(2), and the mean gradient was 60 ± 19 mm Hg. The mean calcium score, calculated using multislice computed tomography, was 4,553 ± 1,872 arbitrary units. The procedure was successful in all but 1 patient. Major adverse events, according to Valvular Academic Research Consortium definitions, were encountered in 1 patient (death). The mean postimplantation prosthetic gradient was 11 ± 4 mm Hg, and ≤1+ periprosthetic leaks were observed in all but 2 patients. The mean prosthetic ellipticity index was 0.7 ± 0.2 at the level of the native annulus and 0.8 ± 0.2 at the level of the prosthetic leaflets. After a mean follow-up period of 8 ± 7 months, 1 patient had died from aortic dissection; there were no additional adverse events. All but 2 hospital survivors were in New York Heart Association class I or II. In conclusion, the present series suggests that transarterial Medtronic CoreValve implantation is feasible in selected patients with bicuspid aortic valve and may lead to short-term hemodynamic and clinical improvement.

Transarterial Medtronic CoreValve system implantation for degenerated surgically implanted aortic prostheses.

BACKGROUND: To assess the results of transcatheter aortic valve implantation (TAVI) using the Medtronic CoreValve System (MCS), through the transarterial approach, in high-risk patients with degenerated surgically implanted aortic bioprostheses (SP). METHODS AND RESULTS: Of 241 patients who underwent TAVI, 10 (4%) had a degenerated SP. The approach was percutaneous transfemoral in 9 cases and surgical transaxillary in 1. Patients were age 75±10 years of age. All were in New York Heart Association classes III or IV and at high risk for repeated surgery. Seven patients had stented, 2 stentless, and 1 homograft SP. The failure mode was predominant regurgitation in 7 cases and stenosis (aortic valve area, 0.7±0.2 cm(2); mean gradient, 58±16 mm Hg) in 3. Based on the echographic measurements, 8 patients received a 26-mm, and 2 a 29-mm-diameter MCS. Procedural success rate was 100%. There was 1 in-hospital death, 1 stroke with moderate sequelae, and 1 pacemaker implantation. There were no other adverse events at 30 days. The mean postimplantation transprosthetic gradient was 13±7 mm Hg; periprosthetic regurgitation was absent or trivial in 9 cases and grade 2 in 1. After a median follow-up of 5 months, there were no additional adverse events. All but 1 of the hospital survivors were in New York Heart Association classes I or II. CONCLUSIONS: These results suggest that transarterial MCS implantation in degenerated SP is feasible and may lead to hemodynamic and clinical improvement in patients who are poor candidates for repeated surgery, pending confirmation in larger series with longer follow-up.

Thirty-day outcome and vascular complications after transarterial aortic valve implantation using both Edwards Sapien and Medtronic CoreValve bioprostheses in a mixed population.

AIMS: Transcatheter aortic valve implantation (TAVI) is performed through a transarterial approach with encouraging results in "one-type valve" registries. We report 30-day data from a mixed population of patients treated with either Medtronic CoreValve (MCV) or Edwards SAPIEN (ES) valves. METHODS AND RESULTS: Forty-five patients had TAVI via the transarterial approach (21 MCV and 24 ES). Mean age was 81.8+/-4.2 years, Logistic EuroSCORE was 25.2+/-8.4%. Procedural success rate was 97.8%. In-hospital death rate was 4.4%. Vascular complication rate was 8.9%. Of MCV patients, 28.6% had a permanent pacemaker vs. 4.2% of ES patients; p=0.02. No additional deaths were observed between discharge and 30 days. NYHA functional class was improved at 30-days: 2.07+/-0.4 vs. 3.09+/-0.05, p<0.0001. Mean transvalvular gradient was lower: 9.5+/-3.28 mmHg vs. 41.9+/-14 mmHg, p<0.0001. Overall 30-day MACE rate was 8.9%, similar between MCV and ES patients. CONCLUSION: A routine policy of TAVI using both MCV and ES valves is feasible without any worsening of procedural success rates and 30-day outcomes. A wider population of high risk patients with aortic stenosis can be offered a transarterial treatment. This could be the next standard of care for teams performing TAVI.

Transcatheter aortic valve implantation: selection strategy is crucial for outcome.

BACKGROUND: We describe the results of transcatheter aortic valve implantation (TAVI) in high-risk patients with aortic stenosis. Transfemoral access was the first option, and if contraindicated, the transapical approach was used. METHODS: Fifty patients were consecutively treated with TAVI because of high surgical risk or contraindications to operation. Mean age was 83 +/- 6 years, and most were in New York Heart Association classes III and IV. The predicted surgical mortality was 28% +/- 14% using the European System for Cardiac Operative Risk Evaluation and 16% +/- 7% using the Society of Thoracic Surgeons Predicted Risk of Mortality. The Edwards-SAPIEN (Edwards Lifesciences Inc, Irvine, CA) valve was implanted using a transfemoral approach in 35 patients and the transapical approach in 15. The transapical patients had more comorbidity (diabetes, previous myocardial infarction, previous coronary artery bypass grafting, peripheral artery disease, renal failure, porcelain aorta, and previous stroke). RESULTS: Successful implantation was 85.7% and 100% in the transfemoral and transapical group, respectively. Gradients were satisfactory. In-hospital mortality was 8% in the transfemoral and 27% in the transapical group. Stroke was only observed in the transfemoral group. Overall 1-year survival was 74% +/- 11% in the transfemoral group and 60% +/- 13% in the transapical. CONCLUSIONS: The results attributed to each approach (transfemoral or transapical) are strongly influenced by the selection strategy. Patients in the transapical group had more comorbidity and consequently a more critical early postoperative period. The respective places of transfemoral and transapical approaches need to be clarified for each approach by a randomized study.

Results of transfemoral or transapical aortic valve implantation following a uniform assessment in high-risk patients with aortic stenosis.

OBJECTIVES: We sought to describe the results of a strategy offering either transfemoral or transapical aortic valve implantation in high-risk patients with severe aortic stenosis. BACKGROUND: Results of transfemoral and transapical approaches have been reported separately, but rarely following a uniform assessment to select the procedure. METHODS: Of 160 consecutive patients at high risk or with contraindications to surgery, referred between October 2006 and November 2008, 75 were treated with transcatheter aortic valve implantation. The transfemoral approach was used as the first option and the transapical approach was chosen when contraindications to the former were present. The valve used was the Edwards Lifesciences SAPIEN prosthesis. RESULTS: Patients were age 82 +/- 8 years (mean +/- SD), in New York Heart Association functional classes III/IV, with predicted mean surgical mortalities of 26 +/- 13% using the European System for Cardiac Operative Risk Evaluation and 16 +/- 7% using the Society of Thoracic Surgeons Predicted Risk of Mortality. Fifty-one patients were treated via the transfemoral approach, and 24 via the transapical approach. The valve was implanted in 93% of the patients. Hospital mortality was 10%. Mean (+/- SD) 1-year survivals were 78 +/- 6% in the whole cohort, 81 +/- 7% in the transfemoral group, 74 +/- 9% in the transapical group (p = 0.22), and 60 +/- 10% in the first 25 patients versus 93 +/- 4% in the last 50 patients treated (p = 0.001). In multivariate analysis, early experience was the only significant predictor of late mortality. CONCLUSIONS: Being able to offer either transfemoral or transapical aortic valve implantation, within a uniform assessment, expands the scope of the treatment of aortic stenosis in high-risk patients and provides satisfactory results at 1 year in this population. The results are strongly influenced by experience.