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1.
JACC Cardiovasc Interv ; 12(22): 2309-2316, 2019 Nov 25.
Artigo em Inglês | MEDLINE | ID: mdl-31753302

RESUMO

OBJECTIVES: This study reports an international experience using the transfemoral ACURATE neo transcatheter heart valve (Boston Scientific, Marlborough, Massachusetts) for the treatment of degenerated surgical aortic bioprostheses. BACKGROUND: Transcatheter valve-in-valve procedures have emerged as an alternative to redo surgery. Supra-annular prostheses might be particularly useful in this indication. METHODS: This is an international multicenter analysis including 85 patients from 14 centers in Europe and Canada undergoing an ACURATE neo valve-in-valve procedure from March 2015 to February 2019. RESULTS: Internal diameter of the degenerated bioprosthesis was 20.3 ± 2.1 mm. Prosthesis size S was used in 70 (82%) procedures. The median depth of implantation was 3 mm and the upper crown of the ACURATE neo was positioned above the stent posts of the degenerated bioprosthesis in 54 (64%) and inside in 31 (36%). Mean transvalvular gradient before discharge was significantly lower if the upper crown was above the degenerated bioprosthesis (13.7 ± 5.9 mm Hg vs. 19.5 ± 10.0 mm Hg; p = 0.001). However, a high position of the ACURATE neo resulted in embolization in 1 patient, conversion to open-heart surgery in 1, and need for reintervention due to transcatheter heart valve failure within the first 18 months of follow-up in 4. CONCLUSIONS: This early experience shows that a high implantation of the ACURATE neo with the upper crown above the stent posts of the degenerated bioprosthesis resulted in lower mean transvalvular gradients but a higher rate of malpositioning and early valve degeneration.

2.
Can J Cardiol ; 35(11): 1437-1448, 2019 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-31679616

RESUMO

Transcatheter aortic valve implantation (TAVI) or replacement has rapidly changed the treatment of patients with severe symptomatic aortic stenosis. It is now the standard of care for patients believed to be inoperable or at high surgical risk, and a reasonable alternative to surgical aortic valve replacement for those at intermediate surgical risk. Recent clinical trial data have shown the benefits of this technology in patients at low surgical risk as well. This update of the 2012 Canadian Cardiovascular Society TAVI position statement incorporates clinical evidence to provide a practical framework for patient selection that does not rely on surgical risk scores but rather on individual patient evaluation of risk and benefit from either TAVI or surgical aortic valve replacement. In addition, this statement features new wait time categories and treatment time goals for patients accepted for TAVI. Institutional requirements and recommendations for operator training and maintenance of competency have also been revised to reflect current standards. Procedural considerations such as decision-making for concomitant coronary intervention, antiplatelet therapy after intervention, and follow-up guidelines are also discussed. Finally, we suggest that all patients with aortic stenosis might benefit from evaluation by the heart team to determine the optimal individualized treatment decision.

3.
EuroIntervention ; 15(10): 857-866, 2019 Nov 20.
Artigo em Inglês | MEDLINE | ID: mdl-31746752

RESUMO

Transcatheter aortic valve implantation (TAVI) has, in less than 20 years, become the dominant interventional treatment for aortic stenosis in developed countries. Its development has been characterised by the growth of procedural expertise and device improvement. Every aspect of this therapy has been investigated, increasing clinical evidence and leading to continued optimisation. The purpose of this review article is to provide an overview of the rapidly changing field of TAVI therapy, briefly describing key past achievements and discussing residual challenges.


Assuntos
Estenose da Valva Aórtica , Próteses Valvulares Cardíacas , Substituição da Valva Aórtica Transcateter , Valva Aórtica , Fluoroscopia , Humanos , Resultado do Tratamento
4.
Circulation ; 2019 Nov 06.
Artigo em Inglês | MEDLINE | ID: mdl-31690104

RESUMO

Background: Prosthetic valve endocarditis (PVE) is a rare but critical mechanism of valve failure and death after transcatheter and surgical aortic valve replacement (TAVR, SAVR) warranting further analysis in modern AVR experience. We characterize the incidence, risk factors, microbiological profile and outcomes of PVE from the PARTNER trials and registries. Methods: We analyzed a pooled cohort of all patients in PARTNER-I and PARTNER-II trials and registries. Patients had severe aortic stenosis, were treated with TAVR or SAVR, and were analyzed with respect to development of PVE. PVE adjudication by a clinical events committee (CEC) was based on modified Duke Criteria. The incidence, infection timing, organism, and association between PVE and all-cause mortality were analyzed. Results: 8,530 patients were included. PVE occurred in 107 cases (5.06 [95%CI, 4.19-6.12] PVE events per 1,000 person-years over a mean follow-up of 2.69±1.55 years). The incidence of TAVR-PVE (5.21 [95%CI, 4.26-6.38] per 1,000 person-years) was not significantly different to SAVR-PVE (4.10 [95%CI, 2.33-7.22] per 1,000 person-years; IRR 1.27 [95%CI, 0.70-2.32]; P=0.44). Temporal risk of PVE was similar for TAVR and SAVR, even after adjusting for competing risk of death (HR 1.15 [95%CI, 0.58-2.28]; P=0.69). Through multivariable analysis, PVE was associated with baseline cirrhosis (IRR 2.86 [95%CI, 1.33-6.16; P=0.007), pulmonary disease (IRR 1.70 [95%CI, 1.16-2.48; P=0.006), and renal insufficiency (IRR 1.71 [95%CI, 1.03-2.83], P=0.04). Timing of PVE was similar between TAVR and SAVR (<30 days: 4.2% vs 8.3%; 31 days-1 year: 52.6% vs 66.7%; >1 year: 43.2% vs 25.0%; P=0.28). Staphylococcus occurred more commonly after SAVR (58.3% vs 28.4% in TAVR; P=0.04). PVE was strongly associated with all-cause mortality after endocarditis diagnosis (HR 4.42 [95%CI, 3.42-5.72; P<0.0001). Conclusions: The widespread adoption of TAVR and application to lower-risk patients makes understanding mechanisms of valve failure increasingly important. PVE is an established mechanism of prosthetic valve failure post-SAVR and TAVR with unclear differences between approaches. We herein demonstrate in the largest trials and registries of TAVR that PVE remains rare, but often fatal, in modern AVR experience and that there is no difference in incidence, predictors, or risk of PVE between TAVR and SAVR. Clinical Trial Registrations: URL: https://ClinicalTrials.gov Unique Identifiers: NCT00530894 (PARTNER I), NCT01314313 (PARTNER IIA), NCT02184442 (PARTNER IIB), NCT03222141 (PII S3HR), NCT03222128 (PII S3i).

5.
Eur Heart J ; 40(38): 3154-3155, 2019 Oct 07.
Artigo em Inglês | MEDLINE | ID: mdl-31573604
6.
EuroIntervention ; 2019 Oct 15.
Artigo em Inglês | MEDLINE | ID: mdl-31607682

RESUMO

AIMS: We assessed the impact of implant depth on hydrodynamic function following valve-in-valve (VIV) intervention using the ALLEGRA (New Valve Technology, Hechingen, Germany) transcatheter heart valve (THV) in three different surgical valve designs. METHODS AND RESULTS: Multiple implantation depths (+2mm, -2mm and -6mm) were tested using a 23mm ALLEGRA THV for VIV intervention in 19mm, 21mm, 23mm, and 25mm Epic, Mitroflow and Magna Ease bioprosthetic valves. Multimodality imaging and hydrodynamic evaluation was performed at each implantation depth. The 23mm ALLEGRA valve had gradients <20mmHg in the Mitroflow and Epic valves sized ³21mm, and in all sizes of the Magna Ease valve. Gradients did not increase significantly at lower implantation depths. The 19mm Epic (+2mm: 20.1±0.6mmHg, -2mm: 18.8±0.5mmHg, -6mm: 22.8±0.3mmHg) and 19mm Mitroflow (+2mm: 24.1±0.2mmHg, -2mm: 31.5±0.3mmHg, -6mm: 25.6±0.2mmHg) valves, had elevated mean gradients. In larger sized surgical valves (³23mm) the regurgitant fraction was higher at low implantation depths. Pinwheeling was significantly worse in the smaller sized (£21mm) surgical valves and also at low (<-2mm) implantation depth. CONCLUSIONS: The 23mm ALLEGRA valve had favourable (<20mmHg) gradients in all surgical valves sized ³21mm, even when the THV was implanted low. In 19mm sized Mitroflow and Epic valves, gradients were elevated (>20mmHg). While there was no major difference in mean transvalvular gradients, leaflet pinwheeling was worse at lower implantation depths.

7.
J Am Coll Cardiol ; 2019 Sep 24.
Artigo em Inglês | MEDLINE | ID: mdl-31568868

RESUMO

BACKGROUND: Tricuspid Regurgitation (TR) is associated with increased rates of heart failure (HF) and mortality. Transcatheter tricuspid valve interventions (TTVI) are promising, but the clinical benefit is unknown. OBJECTIVES: To investigate the potential benefit of TTVI over medical therapy in a propensity score matched population. METHODS: The TriValve (Transcatheter Tricuspid Valve Therapies) registry collected 472 patients from 22 European and North American centers, who underwent TTVI from 2016 to 2018. A control cohort formed by two large retrospective registries enrolling medically managed patients with ≥moderate TR in Europe and North America (1179 pts) were propensity score 1:1 matched (distance ± 0.2 SD) using age, Euroscore II, and systolic pulmonary artery pressure. Survival was tested with Cox regression analysis. Primary endpoint was 1-year mortality or HF rehospitalization or the composite. RESULTS: After matching, 268 adequately matched pairs of patients were identified. Compared to controls, TTVI patients had lower 1-year mortality (23 ±3% vs 36 ±3%, p=0.001), rehospitalization (26 ±3% vs 47 ±3% p<0.0001), and composite endpoint (32 ±4% vs 49 ±3%; p=0.0003). TTVI was associated with greater survival and freedom from HF rehospitalization (HR 0.60 [0.46-0.79], p=0.003 unadjusted) which remained significant after adjusting for sex, NYHA class, right ventricular dysfunction and atrial fibrillation (HR 0.39 [0.26-0.59], p<0.0001) and after further adjustment for mitral regurgitation and pacemaker/defibrillator (HR 0.35 [0.23.54], p<0.0001). CONCLUSIONS: In this propensity matched case-control study, TTVI is associated with greater survival and reduced HF rehospitalization compared with medical therapy alone. Randomized trials should be performed to confirm these results.

8.
Artigo em Inglês | MEDLINE | ID: mdl-31575516

RESUMO

OBJECTIVES: This study assessed the long-term durability of nominally deployed transcatheter heart valves (THV) to 1 billion cycles (equivalent to 25 years) and non-nominal (overexpansion, underexpansion, and elliptical) THV deployments to 200 million cycles (equivalent to 5 years) with accelerated wear testing. BACKGROUND: The long-term durability of THVs is currently unknown. As transcatheter aortic valve replacement expands to lower-risk patients, durability will be of increasing importance. METHODS: SAPIEN 3 THVs, sized 20, 23, 26, and 29 mm were assessed. Nominally deployed THVs underwent hydrodynamic performance and mechanical durability as assessed with accelerated wear testing to 1 billion cycles. Magna Ease surgical valves were used as comparators. Durability of non-nominal THV deployments was tested to 200 million cycles. Valves were tested to International Standards Organization 5840:2013 standard. RESULTS: THV durability was excellent for both the nominal and non-nominal THV deployments to 1 billion and 200 million cycles, respectively. At 1 billion cycles the regurgitant fraction for the 20-, 23-, 26-, and 29-mm SAPIEN 3 was 0.92 ± 0.47%, 1.29 ± 0.04%, 1.73 ± 0.46%, and 2.47 ± 0.15%, respectively. There was also excellent durability in the comparator Magna Ease valves. The regurgitant fraction of non-nominal overexpanded (20 mm, 4.36 ± 0.53; 23 mm, 7.68 ± 1.39; 26 mm, 6.80 ± 1.17; 29 mm, 9.00 ± 0.37), underexpanded (20 mm, 3.06 ± 0.28; 23 mm, 4.46 ± 0.45; 26 mm, 7.72 ± 0.48; 29 mm, 8.65 ± 2.01), and elliptical (20 mm, 3.30 ± 0.38; 23 mm, 6.13 ± 0.94; 26 mm, 6.77 ± 1.22; 29 mm, 8.72 ± 0.24) THVs were excellent at 200 million cycles. CONCLUSIONS: Nominal SAPIEN 3 THVs demonstrated excellent durability, to an equivalent of 25-years wear. THV durability was similar to the comparator surgical valves tested. Non-nominal (overexpansion, underexpansion, and elliptical) THV deployments also had excellent durability to an equivalent of 5-years wear.

9.
J Am Coll Cardiol ; 2019 Sep 18.
Artigo em Inglês | MEDLINE | ID: mdl-31577923

RESUMO

BACKGROUND: In patients with severe aortic stenosis (AS) at low surgical risk, treatment with transcatheter aortic valve replacement (TAVR) results in lower rates of death, stroke, and re-hospitalization at 1 year compared with surgical aortic valve replacement; however, the effect of treatment strategy on health status is unknown. OBJECTIVES: This study sought to compare health status outcomes of TAVR vs. surgery in low-risk patients with severe AS. METHODS: Between 3/2016 and 10/2017, 1000 low-risk AS patients were randomized to transfemoral TAVR using a balloon-expandable valve or surgery in the PARTNER 3 Trial. Health status was assessed at baseline, 1, 6 and 12 months using the Kansas City Cardiomyopathy Questionnaire (KCCQ), SF-36 and EQ-5D. The primary endpoint was change in KCCQ-Overall Summary (KCCQ-OS) score over time. Longitudinal growth curve modeling was used to compare changes in health status between treatment groups over time. RESULTS: At 1 month, TAVR was associated with better health status than surgery (mean difference in KCCQ-OS 16.0 points; p<0.001). At 6 and 12 months, health status remained better with TAVR, although the effect was reduced (mean difference in KCCQ-OS 2.6 and 1.8 points respectively; p<0.04 for both). The proportion of patients with an excellent outcome (alive with KCCQ-OS ≥ 75 and no significant decline from baseline) was greater with TAVR than surgery at 6 months (90.3% vs. 85.3%; p=0.03) and 12 months (87.3% vs. 82.8%; p=0.07). CONCLUSIONS: Among low-risk patients with severe AS, TAVR was associated with meaningful early and late health status benefits compared with surgery.

10.
Artigo em Inglês | MEDLINE | ID: mdl-31647178

RESUMO

AIMS: The commonly used valve-in-valve (VIV) app recommends sizing based on dimensions of both the transcatheter heart valve (THV) and bioprosthetic surgical valve. The implications of hydrodynamic testing to guide VIV sizing are poorly understood. This bench study assessed the hydrodynamic performance of different sizes of self-expanding supra-annular THVs in three different surgical aortic bioprostheses at different implantation depths. METHODS: A small versus medium ACURATE neo (ACn), and a 26 mm versus 29 mm Evolut R were assessed after VIV implantation in 25 mm Mitroflow, Mosaic, and Magna Ease aortic surgical bioprostheses, at three implantation depths (+2 mm, -2 mm, and -6 mm). RESULTS: The medium-sized ACn had lower gradients compared to the small ACn when the THV was implanted high (+2 mm, or -2 mm). The 29 mm Evolut R had lower gradients compared to a 26 mm Evolut R for all implantation depths, except for a depth of -2 mm in the 25 mm Mitroflow. The medium ACn and 29 mm Evolut R had larger effective orifice areas compared to the small ACn and 26 mm Evolut R, respectively. Both Evolut R sizes had acceptable regurgitant fractions (<15%), while both ACn sizes were above the acceptable performance criteria (>15%), at all implantation depths. CONCLUSIONS: Use of a larger self-expanding THV was associated with superior hydrodynamic performance if the THV was implanted high. Hydrodynamic testing can provide additional information to the VIV app to help guide VIV sizing.

11.
Eur Heart J ; 40(27): 2218-2227, 2019 Jul 14.
Artigo em Inglês | MEDLINE | ID: mdl-31505615

RESUMO

AIMS: Transcatheter aortic valve replacement (TAVR) is now an established therapy for intermediate-risk surgical candidates with symptomatic, severe aortic stenosis. The clinical impact of new-onset left bundle branch block (LBBB) after TAVR remains controversial and has not been studied in intermediate-risk patients. We therefore sought to analyse outcomes associated with new LBBB in a large cohort of intermediate-risk patients treated with TAVR. METHODS AND RESULTS: A total of 2043 patients underwent TAVR in the PARTNER II trial and S3 intermediate-risk registry and survived to hospital discharge. Patients were excluded from the current analysis due to baseline conduction disturbances, pre-existing permanent pacemaker (PPM), and new PPM during the index hospitalization. Clinical outcomes at 2 years were compared between patients with and without persistent, new-onset LBBB at hospital discharge, and multivariable analysis was performed to identify predictors of mortality. Among 1179 intermediate-risk patients, new-onset LBBB at discharge occurred in 179 patients (15.2%). Patients with new LBBB were similar to those without except for more frequent diabetes and more frequent treatment with SAPIEN 3 vs. SAPIEN XT. At 2 years, new LBBB was associated with increased rates of all-cause mortality (19.3% vs. 10.8%, P = 0.002), cardiovascular mortality (16.2% vs. 6.5%, P < 0.001), rehospitalization, and new PPM implantation. By multivariable analysis, new LBBB remained an independent predictor of 2-year all-cause [hazard ratio (HR) 1.98, 95% confidence interval (95% CI) 1.33, 2.96; P < 0.001] and cardiovascular (HR 2.66 95% CI 1.67, 4.24; P < 0.001) mortality. New LBBB was also associated with worse left ventricular systolic function at 1 and 2-year follow-up. CONCLUSIONS: In a large cohort of intermediate-risk patients from the PARTNER II trial and registry, persistent, new-onset LBBB occurred in 15.2% of patients without baseline conduction disturbances or pacemaker. New LBBB was associated with adverse clinical outcomes at 2 years, including all-cause and cardiovascular mortality, rehospitalization, new pacemaker implantation, and worsened left ventricular systolic function. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov #NCT01314313 and NCT03222128.

12.
Artigo em Inglês | MEDLINE | ID: mdl-31483555

RESUMO

OBJECTIVES: To perform clinical and echocardiographic follow-up beyond 1 year in consecutive patients with severe bicuspid aortic stenosis (AS) undergoing transcatheter aortic valve replacement (TAVR) with a current generation balloon-expandable valve. BACKGROUND: Treatment of bicuspid aortic valve disease with TAVR remains controversial and late follow-up data is still scarce. METHODS: We collected baseline characteristics, procedural data, 30-day and mid-term clinical follow-up findings from six centers in Europe and Canada from patients with bicuspid AS treated with TAVR using the SAPIEN 3 valve. RESULTS: Seventy-nine patients underwent TAVR. Mean age was 76 ± 9 years; median STS risk score for mortality was 3.8% (interquartile range 2.3-5.5%). Median follow-up was 390 days (interquartile range 138-739 days). Device success was achieved in 95% of patients. Postimplantation mean aortic gradient decreased from 50.2 ± 16.2 to 8.8 ± 4.4 mmHg and no patient had more than mild aortic regurgitation. At last follow-up, there was persistent good valve performance. At 30 days and 1 year, the rates of all-cause mortality were 3.8 and 7.7%, stroke 1.2 and 1.2%, and the rate of new pacemakers 18 and 18%. CONCLUSIONS: Our data confirm that treating patients with stenotic bicuspid aortic valves is safe, effective, and has favorable valve performance over time.

13.
Eur Heart J ; 40(38): 3166-3168, 2019 Oct 07.
Artigo em Inglês | MEDLINE | ID: mdl-31377802
14.
JACC Cardiovasc Interv ; 12(15): 1438-1447, 2019 Aug 12.
Artigo em Inglês | MEDLINE | ID: mdl-31395213

RESUMO

OBJECTIVES: To evaluate the long-term (≥2 years) outcomes following transcatheter tricuspid valve repair (TTVr) with the FORMA Transcatheter Tricuspid Valve Repair System (Edwards Lifesciences, Irvine, California). BACKGROUND: Scarce data exist on long-term outcomes following TTVr. METHODS: This multicenter experience included patients with severe tricuspid regurgitation (TR) who underwent TTVr with the FORMA system at 4 centers under a compassionate clinical use program. Data were collected at baseline, 30 days, and 1 year, and yearly thereafter. RESULTS: Nineteen patients (76 ± 9 years of age, 74% women, mean EuroSCORE II [European System for Cardiac Operative Risk Evaluation] 9.2 ± 5.6%) with functional TR were included. Procedural success was achieved in 17 (89%) patients and there were no cases of 30-day mortality. At a median follow-up of 32 (interquartile range: 24 to 36) months, 4 (24%) patients had died (3 from terminal heart failure, 1 from sepsis) and 3 (18%) patients required rehospitalization for heart failure. There was 1 device-related thrombosis and 1 pulmonary embolism, both in the setting of subtherapeutic oral anticoagulation. Less than severe TR was observed at echocardiography in 67% of patients at the 2- to 3-year follow-up. Among 15 successfully implanted patients with at least 24-month follow-up, significant improvements in New York Heart Association functional class (p < 0.001), 6-min walk test (+54 m; p = 0.016) and Kansas City Cardiomyopathy Questionnaire score (+16 points; p = 0.016) were observed, compared with baseline. CONCLUSIONS: TTVr using the FORMA system showed favorable long-term safety profile in high-surgical-risk patients, with sustained functional improvement and acceptable TR reduction up to 3 years.

15.
Artigo em Inglês | MEDLINE | ID: mdl-31350027

RESUMO

OBJECTIVES: Multisite procedure-based randomized trials may be confounded by performance variability and variability among sites. Therefore, we studied variability in mortality and stroke after patients were randomized to surgical (SAVR) or transcatheter aortic valve replacement (TAVR) in the Placement of Aortic Transcatheter Valves-2A (PARTNER-2A) randomized trial. METHODS: Patients at intermediate risk for SAVR were randomized to SAVR (n = 1017) or TAVR (n = 1011) with a SAPIEN XT device (Edwards Lifesciences, Irvine, Calif) at 54 sites. Patients were followed to 2 years. A mixed-effect model quantified variability at intersite and intrasite levels. RESULTS: There were 336 deaths (SAVR 170, TAVR 166) and 176 strokes (SAVR 85, TAVR 91). Intersite variability for mortality was similar across sites for SAVR (hazard ratios ranging from 0.52-1.93 among sites) and TAVR (hazard ratios ranging from 0.49-2.03), but intersite variability for stroke was greater for SAVR (hazard ratios ranging from 0.44-2.26) than for TAVR (no detectable variability). Case mix and lower site trial volume accounted for 37% of mortality intersite variability for SAVR and 73% for TAVR, but only 14% for stroke for SAVR. Intrasite mortality hazard ratios demonstrated all but 1 site's 95% confidence interval overlapped 1.0, indicating generally similar SAVR and TAVR mortalities within sites. CONCLUSIONS: Intersite variability was similar for mortality in SAVR and TAVR, but variability for stroke was greater for SAVR than for TAVR. Intrasite events were similar for both SAVR and TAVR. These findings suggest that in performance-based trials, site variability and its sources should be taken into account in analyzing and interpreting trial results.

16.
JACC Cardiovasc Interv ; 12(14): 1369-1378, 2019 Jul 22.
Artigo em Inglês | MEDLINE | ID: mdl-31255562

RESUMO

OBJECTIVES: The authors report the procedural and 30-day results of the PASCAL Transcatheter Valve Repair System (Edwards Lifesciences, Irvine, California) in patients with mitral regurgitation (MR) enrolled in the multicenter, prospective, single-arm CLASP study. BACKGROUND: Severe MR may lead to symptoms, impaired quality of life, and reduced functional capacity when untreated. METHODS: Eligible patients had grade 3+ or 4+ MR despite optimal medical therapy and were deemed appropriate for the study by the local heart team. All outcomes were assessed through 30 days post-procedure. Major adverse events (MAEs) were adjudicated by an independent clinical events committee, and echocardiographic images were assessed by a core laboratory. The primary safety endpoint was the rate of MAEs at 30 days. RESULTS: Between June 2017 and September 2018, 62 patients with grade 3+ or 4+ MR were enrolled. The mean age was 76.5 years, and 51.6% of patients were in New York Heart Association functional class III or IV, with 56% functional, 36% degenerative, and 8% mixed MR etiology. At 30 days, the MAE rate was 6.5%, with an all-cause mortality rate of 1.6% and no occurrence of stroke; 98% had MR grade ≤2+, with 86% with MR grade ≤1+ (p < 0.0001); and 85% were in New York Heart Association functional class I or II (p < 0.0001). Six-minute walk distance improved by 36 m (p = 0.0018), and Kansas City Cardiomyopathy Questionnaire and EQ-5D scores improved by 17 (p < 0.0001) and 10 (p = 0.0004) points, respectively. CONCLUSIONS: The PASCAL repair system showed feasibility and acceptable safety in the treatment of patients with grade 3+ or 4+ MR. MR severity, irrespective of etiology, was significantly reduced and accompanied by clinically and statistically significant improvements in functional status, exercise capacity, and quality of life. (The CLASP Study Edwards PASCAL Transcatheter Mitral Valve Repair System Study; NCT03170349).

17.
JACC Cardiovasc Interv ; 12(13): 1238-1239, 2019 Jul 08.
Artigo em Inglês | MEDLINE | ID: mdl-31272670
18.
Circ Cardiovasc Interv ; 12(7): e007258, 2019 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-31296082

RESUMO

BACKGROUND: Open surgical closure and small-bore suture-based preclosure devices have limitations when used for transcatheter aortic valve replacement, percutaneous endovascular abdominal aortic aneurysm repair, or percutaneous thoracic endovascular aortic aneurysm repair. The MANTA vascular closure device is a novel collagen-based technology designed to close large bore arteriotomies created by devices with an outer diameter ranging from 12F to 25F. In this study, we determined the safety and effectiveness of the MANTA vascular closure device. METHODS AND RESULTS: A prospective, single arm, multicenter investigation in patients undergoing transcatheter aortic valve replacement, percutaneous endovascular abdominal aortic aneurysm repair, or thoracic endovascular aortic aneurysm repair at 20 sites in North America. The primary outcome was time to hemostasis. The primary safety outcomes were accessed site-related vascular injury or bleeding complications. A total of 341 patients, 78 roll-in, and 263 in the primary analysis cohort, were entered in the study between November 2016 and September 2017. For the primary analysis cohort, transcatheter aortic valve replacement was performed in 210 (79.8%), and percutaneous endovascular abdominal aortic aneurysm repair or thoracic endovascular aortic aneurysm repair was performed in 53 (20.2%). The 14F MANTA was used in 42 cases (16%), and the 18F was used in 221 cases(84%). The mean effective sheath outer diameter was 22F (7.3 mm). The mean time to hemostasis was 65±157 seconds with a median time to hemostasis of 24 seconds. Technical success was achieved in 257 (97.7%) patients, and a single device was deployed in 262 (99.6%) of cases. Valve Academic Research Consortium-2 major vascular complications occurred in 11 (4.2%) cases: 4 received a covered stent (1.5%), 3 had access site bleeding (1.1%), 2 underwent surgical repair (0.8%), and 2 underwent balloon inflation (0.8%). CONCLUSIONS: In a selected population, this study demonstrated that the MANTA percutaneous vascular closure device can safely and effectively close large bore arteriotomies created by current generation transcatheter aortic valve replacement, percutaneous endovascular abdominal aortic aneurysm repair, and thoracic endovascular aortic aneurysm repair devices. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov . Unique identifier: NCT02908880.

19.
Can J Cardiol ; 35(9): 1114-1123, 2019 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-31202537

RESUMO

BACKGROUND: Chronic kidney disease (CKD) has a negative impact on outcomes after transcatheter aortic valve replacement (TAVR). Data on outcomes in renal transplant recipients (RTRs) undergoing TAVR are scarce. We compared the outcomes in RTRs undergoing TAVR with matched patients who have native kidneys and similar kidney function. METHODS: This retrospective cohort study used data from 16 TAVR centres (13,941 patients). The study cohort included 216 patients (72 RTRs and 144 matched controls). RESULTS: The mean estimated glomerular filtration rate (eGFR) was 39.2 ± 23.6 vs 44.5 ± 23.6 mL/min for RTRs and control patients (P = 0.149), with a similar CKD stage distribution. After TAVR, the eGFR declined among RTRs but remained stable for up to 1 year in controls (P = 0.021). Long-term hemodialysis was required in 19 (26.4%) RTRs and 20 (13.8%) controls (hazard ratio [HR] = 2.09 95% confidence interval [CI], 1.03-3.86; P = 0.039) and was most often initiated during the periprocedural period (14 RTRs vs 16 controls; P = 0.039). After a median follow-up of 2.3 years, risk of death (29.2% vs 31.9%) and death/hemodialysis (40.3% vs 36.8%) was similar between the groups. The contrast volume/eGFR ratio was the strongest predictor of hemodialysis initiation (odds ratio [OR] = 1.64; 95% CI, 1.36-1.97 per 1 unit increase; P < 0.001), with a greater effect among RTRs than controls (P for interaction = 0.022). CONCLUSION: s: TAVR appears safe in RTRs with mortality rates similar to matched patients with native kidneys. However, RTRs carry an increased risk of progressive renal impairment and need for hemodialysis initiation after TAVR. Our data highlight the importance of minimizing contrast load during TAVR, particularly in RTRs.

20.
J Am Heart Assoc ; 8(12): e012355, 2019 Jun 18.
Artigo em Inglês | MEDLINE | ID: mdl-31165666

RESUMO

Background Readmission rates are a widely accepted quality indicator. Our objective was to develop models for calculating case-mixed adjusted readmission rates after transcatheter aortic valve replacement for the purpose of profiling hospitals. Methods and Results In this population-based study in Ontario, Canada, we identified all transcatheter aortic valve replacement procedures between April 1, 2012, and March 31, 2016. For each hospital, we first calculated 30-day and 1-year risk-standardized (predicted versus expected) readmission rates, using 2-level hierarchical logistic regression models, including clustering of patients within hospitals. We also calculated the risk-adjusted (observed versus expected) readmission rates, accounting for the competing risk of death using a Fine-Gray competing risk model. We categorized hospitals into 3 groups: those performing worse than expected, those performing better than expected, or those performing as expected, on the basis of whether the 95% CI was above, below, or included the provincial average readmission rate respectively. Our cohort consisted of 2129 transcatheter aortic valve replacement procedures performed at 10 hospitals. The observed readmission rate was 15.4% at 30 days and 44.2% at 1 year, with a range of 10.9% to 21.7% and 38.8% to 55.0%, respectively, across hospitals. Incorporating the competing risk of death translated into meaningful different results between models; as such, we concluded that the risk-adjusted readmission rate was the preferred metric. On the basis of the 30-day risk-adjusted readmission rate, all hospitals performed as expected, with a 95% CI that included the provincial average. However, we found that there was significant variation in 1-year risk-adjusted readmission rate. Conclusions There is significant interhospital variation in 1-year adjusted readmission rates among hospitals, suggesting that this should be a focus for quality improvement efforts in transcatheter aortic valve replacement.

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