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1.
Artigo em Inglês | MEDLINE | ID: mdl-33034944

RESUMO

OBJECTIVES: This study aimed to present a new approach of thorough preclinical testing of a novel left atrial appendage (LAA) occluder device. BACKGROUND: The development of a safe and effective LAA occluder has been shown to be challenging. METHODS: The novel OMEGATM LAA occluder (Eclipse Medical, Ireland) was tested in a porcine model and three-dimensional (3D) human LAA models - this as a prelude to its first-in-human use. RESULTS: In a first series of in-vivo experiments, the OMEGATM LAA occluder was shown to have a satisfactory device biocompatibility in a porcine model. The design of the OMEGATM device was further refined and optimized following three more series of in-vivo experiments. The second generation OMEGATM device was designed with thinner wires, leading to a profile reduction. Based on in-vitro testing of different OMEGATM device sizes implanted at different depths in human three-dimensional (3D) LAA models, it could be determined that (1) the landing zone should be measured at a median depth of 12 mm from the LAA ostium; (2) the distal self-retaining inverted cup should have 10%-25% compression to minimize device embolization risk; and (3) the disc should be slightly inverted, i.e. pulled into the LAA, to promote complete LAA occlusion. The combined in-vivo and in-vitro testing resulted in an optimized pre-procedural planning of the first-in-human case treated with the OMEGATM device. CONCLUSIONS: This series of carefully planned in-vivo and in-vitro experiments allowed demonstration of the safety and efficacy of the OMEGATM LAA occluder. This approach of thorough preclinical testing of medical devices may reduce the risk of complications in first-in-human cases and may become the standard approach for device development and preclinical testing in the future.

2.
EuroIntervention ; 2020 Sep 15.
Artigo em Inglês | MEDLINE | ID: mdl-32928715

RESUMO

AIMS: To investigate the risk of impaired coronary access and coronary obstruction after REDO-TAVI. METHODS AND RESULTS: Post-procedure multi-detector computed tomography (MDCT) scans of 221 TAVI recipients were analyzed. Increased risk of impaired coronary access was defined as coronary ostium below TAVI commissures with valve-to-aorta distance <2mm at this level. Increased risk was found in 123 (55.6%) cases, the left main involved in 109 (49.3%), the right coronary in 79 (35.7%), both in 65 (29.4%) patients. Small sino-tubular junction (STJ width OR 0.68, CI 0.56-0.81, P<0.001; STJ height OR 0.81, CI 0.69-0.95, P<0.011) and supra-annular devices (OR 19.8, CI 6.6-58.8, P<0.001) predicted increased risk. Increased risk of coronary obstruction defined as coronary ostium below TAVI commissures with valve-to-coronary distance <2mm was observed in 14.9% of patients, and in 17.2% of cases complete sealing of STJ would occur. CONCLUSIONS: Post-TAVI MDCT suggested an increased potential risk of impaired coronary access in more than half of patients should REDO-TAVI be required, predicted by small STJ and supra-annular device design. Furthermore, 10-20% of patients presented an increased risk of coronary obstruction. While this theoretical study is hypothesis-generating, it raises concerns that need to be further investigated and addressed before TAVI is extended to patients with longer life expectancy.

3.
Circulation ; 2020 Sep 25.
Artigo em Inglês | MEDLINE | ID: mdl-32975133

RESUMO

Background: Mitral valve-in-valve (ViV) and valve-in-ring (ViR) are alternatives to surgical reoperation in patients with recurrent mitral valve failure after previous surgical valve repair or replacement. Our aim was to perform a large-scale analysis examining mid-term outcomes after mitral ViV and ViR. Methods: Patients undergoing mitral ViV and ViR were enrolled in the Valve-in-Valve International Data Registry. Cases were performed between March 2006 and March 2020. Clinical endpoints are reported according to the Mitral Valve Academic Research Consortium (MVARC) definitions. Significant residual mitral stenosis (MS) was defined as mean gradient ≥10 mmHg and significant residual mitral regurgitation (MR) as ≥ moderate. Results: A total of 1,079 patients (857 ViV, 222 ViR; mean age 73.5 years ± 12.5; 40.8% male) from 90 centers were included. Median STS-PROM score 8.6%; median clinical follow-up 492 days [IQR 76 - 996 days]; median echocardiographic follow-up for patients that survived 1 year 772.5 days [IQR 510 - 1211.75 days]. Four-year Kaplan-Meier survival rate was 62.5% in ViV vs. 49.5% for ViR (p<0.001). Mean gradient across the mitral valve post-procedure was 5.7 ± 2.8 mmHg (≥5mmHg, 61.4% of patients). Significant residual MS occurred in 8.2% of the ViV and 12.0% of the ViR patients (p=0.09). Significant residual MR was more common in ViR patients (16.6% vs. 3.1%; p<0.001) and was associated with lower survival at 4 years (35.1% vs. 61.6%; p=0.02). The rates of MVARC-defined device success were low for both procedures (39.4% total; 32.0% ViR vs. 41.3% ViV; p=0.01), mostly related to having post-procedural mean gradient ≥5mmHg. Correlates for residual MS were smaller true internal diameter, younger age and larger body mass index. The only correlate for residual MR was ViR. Significant residual MS (SHR 4.67; 95% CI 1.74 - 12.56; p=0.002) and significant residual MR (SHR 7.88; 95% CI 2.88 - 21.53; p<0.001) were both independently associated with repeat mitral valve replacement. Conclusions: Significant residual MS and/or MR were not infrequent after mitral ViV and ViR procedures and were both associated with a need for repeat valve replacement. Strategies to improve post-procedural hemodynamics in mitral ViV and ViR should be further explored.

4.
J Am Coll Cardiol ; 76(9): 1018-1030, 2020 Sep 01.
Artigo em Inglês | MEDLINE | ID: mdl-32854836

RESUMO

BACKGROUND: Bicuspid aortic stenosis accounts for almost 50% of patients undergoing surgical aortic valve replacement in the younger patients. Expanding the indication of transcatheter aortic valve replacement (TAVR) toward lower-risk and younger populations will lead to increased use of TAVR for patients with bicuspid aortic valve (BAV) stenosis despite the exclusion of bicuspid anatomy in all pivotal clinical trials. OBJECTIVES: This study sought to evaluate the association of BAV morphology and outcomes of TAVR with the new-generation devices. METHODS: Patients with BAV confirmed by central core laboratory computed tomography (CT) analysis were included from the international multicenter BAV TAVR registry. BAV morphology including the number of raphe, calcification grade in raphe, and leaflet calcium volume were assessed with CT analysis in a masked fashion. Primary outcomes were all-cause mortality at 1 and 2 years, and secondary outcomes included 30-day major endpoints and procedural complications. RESULTS: A total of 1,034 CT-confirmed BAV patients with a mean age of 74.7 years and Society of Thoracic Surgeons score of 3.7% underwent TAVR with contemporary devices (n = 740 with Sapien 3; n = 188 with Evolut R/Pro; n = 106 with others). All-cause 30-day, 1-year, and 2-year mortality was 2.0%, 6.7%, and 12.5%, respectively. Multivariable analysis identified calcified raphe and excess leaflet calcification (defined as more than median calcium volume) as independent predictors of 2-year all-cause mortality. Both calcified raphe plus excess leaflet calcification were found in 269 patients (26.0%), and they had significantly higher 2-year all-cause mortality than those with 1 or none of these morphological features (25.7% vs. 9.5% vs. 5.9%; log-rank p < 0.001). Patients with both morphological features had higher rates of aortic root injury (p < 0.001), moderate-to-severe paravalvular regurgitation (p = 0.002), and 30-day mortality (p = 0.016). CONCLUSIONS: Outcomes of TAVR in bicuspid aortic stenosis depend on valve morphology. Calcified raphe and excess leaflet calcification were associated with increased risk of procedural complications and midterm mortality. (Bicuspid Aortic Valve Stenosis Transcatheter Aortic Valve Replacement Registry; NCT03836521).

5.
EuroIntervention ; 2020 Aug 04.
Artigo em Inglês | MEDLINE | ID: mdl-32748789

RESUMO

AIMS: The Evolut PRO is a new transcatheter heart valve with an outer pericardial wrap intended to reduce paravalvular leak and facilitate tissue ingrowth. We evaluated clinical performance and safety of the Evolut PRO valve in standard practice. METHODS AND RESULTS: FORWARD PRO is a prospective, multinational, multicenter observational study. Transcatheter aortic valve implantation with the Evolut PRO valve (23-, 26-, or 29-mm) was attempted in 629 non-consecutive patients from 39 centers from February 2018 to January 2019. The primary endpoint was the rate of all-cause mortality at 30 days compared to a prespecified performance goal. An independent Clinical Events Committee adjudicated safety endpoints based on VARC-2 definitions. All echocardiograms were centrally assessed by an independent core laboratory (Mayo Clinic, Rochester, MN). Baseline characteristics include mean age 81.7±6.1 years, 61.8% female, STS score 4.7%±3.3%, and 33.6% were frail. All-cause mortality at 30 days was 3.2% was lower than the prespecified performance goal of 5.5% (p=0.004). Greater than mild AR was present in 1.8% of patients at discharge. CONCLUSIONS: The FORWARD PRO study confirmed the safety and efficacy of the Evolut PRO transcatheter aortic valve system with an external pericardial wrap.

7.
Open Heart ; 7(2)2020 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-32763967

RESUMO

BACKGROUND: Optimal preprocedural planning is essential to ensure successful device closure of the left atrial appendage (LAA). DESIGN: The PREDICT-LAA study is a prospective, international, multicentre, randomised controlled trial (ClinicalTrials.gov NCT04180605). Two hundred patients eligible for LAA closure with an Amplatzer Amulet device (Abbott, USA) will be enrolled in the study. Patients will be allocated to a computational simulation arm (experimental) or standard treatment arm (control) using a 1:1 randomisation. For patients randomised to the computational simulation arm, preprocedural planning will be based on the analysis of cardiac computed tomography (CCT)-based patient-specific computational simulations (FEops HEARTguide, Ghent, Belgium) in order to predict optimal device size and position. For patients in the control arm, preprocedural planning will be based on local practice including CCT analysis. The LAA closure procedure and postprocedural antithrombotic therapy will follow local practice in both arms. The primary endpoint of the study is incomplete LAA closure and device-related thrombus as assessed at 3 months postprocedural CCT. Secondary endpoints encompass procedural efficiency (number of devices used, number of repositioning, procedural time, radiation exposure, contrast dye), procedure-related complications within 7 days postprocedure and a composite of all-cause death and thromboembolic events at 12 months. CONCLUSION: The objective of the PREDICT-LAA study is to test the hypothesis that a preprocedural planning for LAA closure with the Amplatzer Amulet device based on patient-specific computational simulations can result in a more efficient procedure, optimised procedural outcomes and better clinical outcomes as compared with a standard preprocedural planning. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov Registry (NCT04180605).

8.
Sci Rep ; 10(1): 13410, 2020 Aug 07.
Artigo em Inglês | MEDLINE | ID: mdl-32770039

RESUMO

Resuscitative endovascular balloon occlusion of the aorta (REBOA) is a technique where a balloon is advanced through the common femoral artery and temporarily inflated for treatment of cardiac arrest or non-compressible haemorrhage. The aim of this study was to measure intravascular distances relevant for correct placement of the REBOA catheter using computer tomographic (CT) scans. In a series of CT scans of the aorta from 100 patients diagnosed with severe aortic stenosis planned for transcatheter aortic valve implantation, we measured the intravascular distance from the insertion site in the common femoral artery to two potential zones for placement of the REBOA catheter; between the left subclavian artery and the celiac trunk (Zone 1), as well as between the aortic bifurcation and the distal take-off of the renal arteries (Zone 3). The mean (± SD) intravascular distance from the femoral artery to intra-aortic Zone 1 was 36 (± 2.5) cm for the lower border and 60 (± 4.1) cm for the upper border, respectively. For intra-aortic Zone 3, the mean (± SD) intravascular distance was 21 (± 2.1) cm to the lower border and 31 (± 2.3) cm to the upper border. Calculated potentially safe intervals for placement of the REBOA in Zone 1 was with 99.7% likelihood between 43 and 48 cm. No similar potentially safe interval could be calculated for Zone 3. According to this cohort study of patients with severe aortic stenosis, the balloon of the REBOA catheter should travel intraarterially between 43 (lower limit) and 48 cm (upper limit) from the site of insertion into the common femoral artery, which would lead to correct placement in intra-aortic Zone 1 in 99.7% of cases. In contrast, no potential safety interval could be similarly defined for insertion in Zone 3.

10.
Artigo em Inglês | MEDLINE | ID: mdl-32621567

RESUMO

Aortic annulus rupture or aortic root perforation is a rare complication of transcatheter aortic valve replacement (TAVR), requiring emergent cardiac surgery and carrying a high intraoperative mortality. Few cases can be managed conservatively, provided a strict clinical follow-up. This study describes the case of a 78-year-old patient with a degenerated bicuspid aortic valve stenosis who presented with a late aortic root perforation following TAVR, which was successfully managed applying a "watchful waiting" approach. Cardiac computed tomography imaging played a pivotal role in the diagnosis and subsequent decision on treatment and clinical follow-up.

11.
JACC Cardiovasc Interv ; 13(15): 1803-1812, 2020 Aug 10.
Artigo em Inglês | MEDLINE | ID: mdl-32682679

RESUMO

OBJECTIVES: The aim of this study was to assess the added value and predictive power of the TAVIguide (Added Value of Patient-Specific Computer Simulation in Transcatheter Aortic Valve Implantation) software in clinical practice. BACKGROUND: Optimal outcome after transcatheter aortic valve replacement (TAVR) may become more important as TAVR shifts toward low-risk patients. Patient-specific computer simulation is able to provide prediction of outcome after TAVR. Its clinical role and validation of accuracy, however, have not yet been studied prospectively. METHODS: A prospective, observational, multicenter study was conducted among 80 patients with severe aortic stenosis treated with the Evolut R valve. Simulation was performed in 42 patients and no simulation in 38. A comparison between the valve size (decision 1) and target depth of implantation selected by the operator on the basis of multislice computed tomography and the valve size (decision 2) and target depth of implantation selected after simulation were the primary endpoints. Predictive power was examined by comparing the simulated and observed degree of aortic regurgitation. RESULTS: Decision 2 differed from decision 1 in 1 of 42 patients because of predicted paravalvular leakage, and changes in valve type occurred in 2 of 42. In 39 of 42 patients, decisions 1 and 2 were similar. Target depth of implantation differed in 7 of 42 patients after simulation (lower in 4 and higher in 3). In 16 of 42 patients, simulation affected the TAVR procedure; in 9, the operator avoided additional measures to achieve the target depth of implantation, and in 7 patients, additional measures were performed. There was a trend toward a higher degree of predicted than observed aortic regurgitation (17.5 vs. 12 ml/s; p = 0.13). CONCLUSIONS: Patient-specific computer simulation did not affect valve size selection but did affect the selection of the target depth of implantation and the execution of TAVR to achieve the desired target depth of implantation.

12.
Artigo em Inglês | MEDLINE | ID: mdl-32609437

RESUMO

OBJECTIVES: This study aimed to assess the feasibility and safety of conducting an entire transcatheter aortic valve replacement (TAVR) program by using percutaneous techniques only. BACKGROUND: Surgically assisted transthoracic TAVR has been reported to be associated with more complications and longer hospital stays. METHODS: During 2019, all TAVR at a single center were performed by standard transfemoral (TF), intravascular lithotripsy-assisted TF, transaxillary (TAx), or transcaval approach using percutaneous techniques only. No patients were denied TAVR because of access. Procedural and clinical endpoints were categorized using Valve Academic Research Consortium-2 criteria. RESULTS: In total, 306 consecutive TAVR patients were enrolled (mean age 78.9 ± 7.2 years). Most patients were treated by TF approach (94.8%)-of these, nine (2.9%) were pre-treated with intravascular lithotripsy. A percutaneous TAx and transcaval approach were used in 12 (3.9%) and four patients (1.3%), respectively. There were no procedural deaths and one peri-procedural stroke. Valve performance was satisfying in 298 patients (97.4%); six patients had a moderate aortic regurgitation and two patients had a mean gradient ≥20 mmHg following valve-in-valve procedure. The 30-day major vascular complication and major bleeding rate was 2.3% and 3.9%, respectively. A new permanent pacemaker was implanted in 41 patients (13.4%). Of all patients, 81% were discharged within two days post-TAVR, including 11 out of 12 TAx patients and all transcaval cases. CONCLUSIONS: A fully percutaneous TAVR program is feasible and safe with favorable immediate and early clinical outcomes and allowing a short hospital stay.

13.
Circ Cardiovasc Interv ; 13(7): e008714, 2020 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-32646304

RESUMO

BACKGROUND: Large data comparing the performance of new-generation self-expandable versus balloon-expandable transcatheter heart valves in bicuspid aortic stenosis are lacking. We aim to compare the safety and performance of balloon-expandable and self-expandable transcatheter heart valves in the treatment of bicuspid aortic stenosis. METHODS: The BEAT (balloon versus self-expandable valve for the treatment of bicuspid aortic valve stenosis) registry included 353 consecutive patients who underwent transcatheter aortic valve implantation using new-generation Evolut R/PRO or Sapien 3 valves in bicuspid aortic valve. RESULTS: A total of 353 patients (n=242 [68.6%] treated with Sapien 3 and n=111 [68.6%] treated with Evolut R (n=70)/PRO [n=41]) were included. Mean age was 77.8±8.3 years and mean Society of Thoracic Surgeons Predicted Risk of Mortality was 4.4±3.3%. Valve Academic Research Consortium-2 device success was similar between Sapien 3 and Evolut R/PRO (85.6% versus 87.2%; P=0.68). In the Sapien 3 group, 4 patients experienced annular rupture whereas this complication did not occur in the Evolut R/PRO group. After propensity score matching, Valve Academic Research Consortium-2 device success was similar between both groups (Sapien 3=85.7% versus Evolut R/Pro=84.4%; P=0.821). Both in the overall and in the matched population, no differences in the rate of permanent pacemaker implant were observed. At 1-year follow-up, the rate of overall death and cardiovascular death were similar between the 2 groups. In the unmatched population, the 1-year echocardiographic follow-up demonstrated similar rate of moderate-to-severe paravalvular aortic regurgitation (Evolut R/PRO 10.5% versus Sapien 3 4.2%, P=0.077); however, after propensity matching, the rate of moderate-to-severe paravalvular leak became significantly higher among patients treated with self-expandable valves (9.3% versus 0%; P=0.043). CONCLUSIONS: Our study confirms the feasibility of both Sapien 3 and Evolut R/PRO implantation in bicuspid aortic valve anatomy; a higher rate of moderate-severe paravalvular aortic regurgitation was observed in the Evolut R/PRO group at 1-year follow-up in the matched cohort, although patients treated with balloon-expandable valve had a higher rate of annular rupture.

14.
JACC Cardiovasc Interv ; 13(13): 1529-1540, 2020 Jul 13.
Artigo em Inglês | MEDLINE | ID: mdl-32646693

RESUMO

OBJECTIVES: The aim of this analysis was to evaluate outcomes following transcatheter reintervention for degenerated transcatheter pulmonary valves (TPVs). BACKGROUND: TPV replacement (TPVR) with the Melody valve demonstrated sustained relief of right ventricular outflow tract (RVOT) obstruction and pulmonary regurgitation. METHODS: All patients who underwent TPVR with a Melody valve as part of 3 Medtronic-sponsored prospective multicenter studies were included. Transcatheter reinterventions included balloon dilation of the previously implanted Melody valve, placement of a bare-metal stent within the implanted TPV, or placement of a new TPV in the RVOT (TPV-in-TPV). Indications for reintervention, decisions to reintervene, and the method of reintervention were at physician discretion. All patients provided written informed consent to participate in the trials, and each trial was approved by local or central Institutional Review Boards or ethics committees at participating sites. RESULTS: A total of 309 patients who underwent TPVR were discharged from the implantation hospitalization with Melody valves in place. Transcatheter reintervention on the TPV was performed in 46 patients. The first transcatheter reintervention consisted of TPV-in-TPV in 28 patients (median 6.9 years [quartile 1 to quartile 3: 5.2 to 7.8 years] after TPVR), simple balloon dilation of the implanted Melody valve in 17 (median 4.9 years [quartile 1 to quartile 3: 4.0 to 6.0 years] after TPVR), and bare-metal stent placement alone in 1 (4.4 years after TPVR). There were no major procedural complications. Overall, 4-year freedom from explant and from any later RVOT reintervention after the first reintervention were 83% and 60%, respectively. Freedom from repeat RVOT reintervention was longer in patients undergoing TPV-in-TPV than balloon dilation (71% vs. 46% at 4 years; p = 0.027). CONCLUSIONS: TPV-in-TPV can be an effective and durable treatment for Melody valve dysfunction. Although balloon dilation of the Melody valve was also acutely effective at reducing RVOT obstruction, the durability of this therapy was limited in this cohort compared with TPV-in-TPV.

15.
Eur Heart J ; 41(29): 2731-2742, 2020 Aug 01.
Artigo em Inglês | MEDLINE | ID: mdl-32592401

RESUMO

AIMS: Due to bioprosthetic valve degeneration, aortic valve-in-valve (ViV) procedures are increasingly performed. There are no data on long-term outcomes after aortic ViV. Our aim was to perform a large-scale assessment of long-term survival and reintervention after aortic ViV. METHODS AND RESULTS: A total of 1006 aortic ViV procedures performed more than 5 years ago [mean age 77.7 ± 9.7 years; 58.8% male; median STS-PROM score 7.3% (4.2-12.0)] were included in the analysis. Patients were treated with Medtronic self-expandable valves (CoreValve/Evolut, Medtronic Inc., Minneapolis, MN, USA) (n = 523, 52.0%), Edwards balloon-expandable valves (EBEV, SAPIEN/SAPIEN XT/SAPIEN 3, Edwards Lifesciences, Irvine, CA, USA) (n = 435, 43.2%), and other devices (n = 48, 4.8%). Survival was lower at 8 years in patients with small-failed bioprostheses [internal diameter (ID) ≤ 20 mm] compared with those with large-failed bioprostheses (ID > 20 mm) (33.2% vs. 40.5%, P = 0.01). Independent correlates for mortality included smaller-failed bioprosthetic valves [hazard ratio (HR) 1.07 (95% confidence interval (CI) 1.02-1.13)], age [HR 1.21 (95% CI 1.01-1.45)], and non-transfemoral access [HR 1.43 (95% CI 1.11-1.84)]. There were 40 reinterventions after ViV. Independent correlates for all-cause reintervention included pre-existing severe prosthesis-patient mismatch [subhazard ratio (SHR) 4.34 (95% CI 1.31-14.39)], device malposition [SHR 3.75 (95% CI 1.36-10.35)], EBEV [SHR 3.34 (95% CI 1.26-8.85)], and age [SHR 0.59 (95% CI 0.44-0.78)]. CONCLUSIONS: The size of the original failed valve may influence long-term mortality, and the type of the transcatheter valve may influence the need for reintervention after aortic ViV.

16.
Ann Vasc Surg ; 68: 536-541, 2020 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-32502673

RESUMO

BACKGROUND: The absence of recommendations for the systematic collection of microbiological specimens to help determine the management of infective native aortic aneurysms (INAAs) may lead to diagnostic difficulty and suboptimal antibiotic treatment. In this review, we attempt to establish recommendations in the field by identifying current strategies for the diagnosis and management of INAA and comparing them with those for infective endocarditis (IE). METHODS: A systematic literature review of Medline and ScienceDirect databases was performed using PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-analyses)methodology to identify guidelines for the management of INAA. These guidelines were scrutinized for recommendations concerning the procurement of microbiological specimens according to a defined protocol and involvement of specialists in infectious diseases and compared with current practice for IE. RESULTS: Three guidelines were found to have sections dedicated to INAA. Of these, none provided any recommendations concerning the procurement of microbiological specimens for diagnostic and therapeutic purposes. The guidelines from the American Heart Association recommend that patients with INAA should be managed by a team of specialists (including representation from the fields of infectious diseases and/or microbiology). Current guidelines for the investigation and management of IE provide detailed recommendations concerning the procurement of microbiological specimens for diagnostic and therapeutic purposes, as well as the involvement of specialists in infectious medicine in multidisciplinary management. CONCLUSION: This article emphasizes the absence of recommendations for the optimal diagnosis and management of patients with INAAs. While specific research is required to create evidence-based recommendations, application of strategies to identify microorganisms and multidisciplinary team management derived from the management of IE may be both safe and appropriate for the clinical management of this highly complex and heterogeneous group.

17.
JACC Cardiovasc Interv ; 13(11): 1303-1311, 2020 Jun 08.
Artigo em Inglês | MEDLINE | ID: mdl-32499020

RESUMO

OBJECTIVES: The aim of this study was to assess acute regurgitation following transcatheter aortic valve replacement, comparing different implanted transcatheter heart valves. BACKGROUND: Regurgitation following transcatheter aortic valve replacement influences all-cause mortality. Thus far, no quantitative comparison of regurgitation among multiple commercially available transcatheter heart valves has been performed. METHODS: Aortograms from a multicenter cohort of consecutive 3,976 transcatheter aortic valve replacements were evaluated in this pooled analysis. A total of 2,258 (58.3%) were considered analyzable by an independent academic core laboratory using video densitometry. Results of quantitative regurgitation are shown as percentages. The valves evaluated were the ACURATE (n = 115), Centera (n = 11), CoreValve (n = 532), Direct Flow Medical (n = 21), Evolut PRO (n = 95), Evolut R (n = 295), Inovare (n = 4), Lotus (n = 546), Lotus Edge (n = 3), SAPIEN XT (n = 239), and SAPIEN 3 (n = 397). For the main analysis, only valves with more than 50 procedures (7 types) were used. RESULTS: The Lotus valve had the lowest mean regurgitation (3.5 ± 4.4%), followed by Evolut PRO (7.4 ± 6.5%), SAPIEN 3 (7.6 ± 7.1%), Evolut R (7.9 ± 7.4%), SAPIEN XT (8.8 ± 7.5%), ACURATE (9.6 ± 9.2%) and CoreValve (13.7 ± 10.7%) (analysis of variance p < 0.001). The only valves that statistically differed from all their counterparts were Lotus (as the lowest regurgitation) and CoreValve (the highest). The proportion of patients presenting with moderate or severe regurgitation followed the same ranking order: Lotus (2.2%), Evolut PRO (5.3%), SAPIEN 3 (8.3%), Evolut R (8.8%), SAPIEN XT (10.9%), ACURATE (11.3%), and CoreValve (30.1%) (chi-square p < 0.001). CONCLUSIONS: In this pooled analysis stemming from daily clinical practice, the Lotus valve was shown to have the best immediate sealing. This analysis reflects the objective evaluation of regurgitation by an academic core laboratory (nonsponsored) in a real-world cohort of patients using a quantitative technique.

18.
EuroIntervention ; 2020 May 04.
Artigo em Inglês | MEDLINE | ID: mdl-32364502

RESUMO

AIMS: TAVI expansion will imply an increase in the frequency of emergent or late cardiac surgery after THV implantation. This study was designed to investigate the anatomical feasibility of surgical cross-clamp and aortotomy after TAVI through a post-TAVI CT-scan assessment. METHODS AND RESULTS: We retrospectively analyzed 117 CTs acquired after TAVI procedures with high stent prostheses in three high-volume centers between October 2008 and May 2017. The mean distance observed between the innominate artery and the top of the transcatheter heart valve was 45 ± 11 mm, being < 30 mm in 8/117 (6.8%) patients and < 20 mm in none. The mean distance between the sino-tubular junction and the first free site for aortotomy being 22 ± 7 mm (> 20 mm in 78/117 [66.7%] cases). A total of 56/117 (47.9%) patients showed a complete continuous contact between the anterior aortic wall and the anterior part of the valve stent. CONCLUSIONS: Aortic cross-clamp appears to not be an issue when cardiac surgery is needed after a TAVI, but a careful and possibly higher aortotomy may be required. CT should be performed prior to planned cardiac surgery after TAVI to determine a safe positioning for aortic cross-clamp and aortotomy.

19.
J Am Coll Cardiol ; 75(16): 1882-1893, 2020 Apr 28.
Artigo em Inglês | MEDLINE | ID: mdl-32327098

RESUMO

BACKGROUND: Transcatheter aortic valve replacement (TAVR) use is increasing in patients with longer life expectancy, yet robust data on the durability of transcatheter heart valves (THVs) are limited. Redo-TAVR may play a key strategy in treating patients in whom THVs fail. OBJECTIVES: The authors sought to examine outcomes following redo-TAVR. METHODS: The Redo-TAVR registry collected data on consecutive patients who underwent redo-TAVR at 37 centers. Patients were classified as probable TAVR failure or probable THV failure if they presented within or beyond 1 year of their index TAVR, respectively. RESULTS: Among 63,876 TAVR procedures, 212 consecutive redo-TAVR procedures were identified (0.33%): 74 within and 138 beyond 1 year of the initial procedure. For these 2 groups, TAVR-to-redo-TAVR time was 68 (38 to 154) days and 5 (3 to 6) years. The indication for redo-TAVR was THV stenosis in 12 (16.2%) and 51 (37.0%) (p = 0.002) and regurgitation or combined stenosis-regurgitation in 62 (83.8%) and 86 (62.3%) (p = 0.028), respectively. Device success using VARC-2 criteria was achieved in 180 patients (85.1%); most failures were attributable to high residual gradients (14.1%) or regurgitation (8.9%). At 30-day and 1-year follow-up, residual gradients were 12.6 ± 7.5 mm Hg and 12.9 ± 9.0 mm Hg; valve area 1.63 ± 0.61 cm2 and 1.51 ± 0.57 cm2; and regurgitation ≤mild in 91% and 91%, respectively. Peri-procedural complication rates were low (3 stroke [1.4%], 7 valve malposition [3.3%], 2 coronary obstruction [0.9%], 20 new permanent pacemaker [9.6%], no mortality), and symptomatic improvement was substantial. Survival at 30 days was 94.6% and 98.5% (p = 0.101) and 83.6% and 88.3% (p = 0.335) at 1 year for patients presenting with early and late valve dysfunction, respectively. CONCLUSIONS: Redo-TAVR is a relatively safe and effective option for selected patients with valve dysfunction after TAVR. These results are important for applicability of TAVR in patients with long life expectancy in whom THV durability may be a concern.

20.
JAMA Neurol ; 77(7): 878-886, 2020 Jul 01.
Artigo em Inglês | MEDLINE | ID: mdl-32282016

RESUMO

Importance: Recent epidemiologic and therapeutic advances have transformed understanding of the role of and therapeutic approach to patent foramen ovale (PFO) in ischemic stroke. Patent foramen ovale is likely responsible for approximately 5% of all ischemic strokes and 10% of those occurring in young and middle-aged adults. Observations: Randomized clinical trials have demonstrated that, to prevent recurrent ischemic stroke in patients with PFO and an otherwise-cryptogenic index ischemic stroke, PFO closure is superior to antiplatelet medical therapy alone; these trials have provided some evidence that, among medical therapy options, anticoagulants may be more effective than antiplatelet agents. Conclusions and Relevance: These new data indicate a need to update classification schemes of causative mechanisms in stroke, developed in an era in which an association between PFO and stroke was viewed as uncertain. We propose a revised general nomenclature and classification framework for PFO-associated stroke and detailed revisions for the 3 major stroke subtyping algorithms in wide use.

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