Publications by authors named "Martin B Leon"

753 Publications

Novel Supreme DES with Early Synchronized Antiproliferative Drug Delivery to Inhibit Smooth Muscle Cell Proliferation after DES implantation in Coronary Artery Disease: Results of the PIONEER III Randomized Clinical Trial.

Circulation 2021 Apr 6. Epub 2021 Apr 6.

Cardivascular Research Foundation, New York, NY; College of Physicians and Surgeons, Columbia University, New York, NY.

Accelerated endothelial healing after targeted antiproliferative drug delivery may limit the long-term inflammatory response of drug eluting stents (DES). The novel Supreme DES (Supreme) is designed to synchronize early drug delivery within 4-6 weeks of implantation, leaving behind a pro-healing permanent base layer. Whether the Supreme DES is safe and effective in the short term and can improve long term clinical outcomes is not known. In an international 2:1 randomized single-blind trial, we compared treatment with Supreme DES to durable polymer everolimus-eluting stents (DP-DES) in patients with acute and chronic coronary syndromes. The primary endpoint was target lesion failure (TLF) - a composite of cardiac death, target vessel myocardial infarction, or clinically-driven target lesion revascularisation (TLR). The trial was designed to demonstrate non-inferiority (margin of 3.58%) of the Supreme DES at 12 months compared to DP-DES (clinicaltrials.gov-NCT03168776). From October 2017 to July 2019, a total of 1629 patients were randomly assigned (2:1) to the Supreme DES (N=1086) or DP-DES (N=543). At 12 months, TLF occurred in 57 of 1057 patients (5.4%) in the Supreme DES group and in 27 of 532 patients (5.1%) in the DP-DES group (Absolute Risk Difference 0.32%, 95%CI [-1.87%, 2.5%]; p=0.002]. There were no significant differences in rates of device success, clinically driven TLR or stent thrombosis at 12 months, and the safety composite of CV Death and TV MI was 3.5% vs 4.6%; HR [95.0% CI] 0.76 [0.46, 1.25] with Supreme DES compared to DP-DES, though rates of combined clinical and non-clinical driven TLR at 12 months were higher with Supreme DES. Among patients with acute and chronic coronary syndromes undergoing percutaneous coronary intervention, the Supreme DES proved to be non-inferior to the standard DP-DES. URL: https://www.clinicaltrials.gov Unique Identifier: NCT03168776.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1161/CIRCULATIONAHA.120.052482DOI Listing
April 2021

Pulmonary Embolism Response Team utilization during the COVID-19 pandemic.

Vasc Med 2021 Apr 4:1358863X21995896. Epub 2021 Apr 4.

Department of Cardiology, Columbia Irving Medical Center, New York, NY, USA.

Coronavirus disease 2019 (COVID-19) may predispose patients to venous thromboembolism (VTE). Limited data are available on the utilization of the Pulmonary Embolism Response Team (PERT) in the setting of the COVID-19 global pandemic. We performed a single-center study to evaluate treatment, mortality, and bleeding outcomes in patients who received PERT consultations in March and April 2020, compared to historical controls from the same period in 2019. Clinical data were abstracted from the electronic medical record. The primary study endpoints were inpatient mortality and GUSTO moderate-to-severe bleeding. The frequency of PERT utilization was nearly threefold higher during March and April 2020 ( = 74) compared to the same period in 2019 ( = 26). During the COVID-19 pandemic, there was significantly less PERT-guided invasive treatment (5.5% vs 23.1%, = 0.02) with a numerical but not statistically significant trend toward an increase in the use of systemic fibrinolytic therapy (13.5% vs 3.9%, = 0.3). There were nonsignificant trends toward higher in-hospital mortality or moderate-to-severe bleeding in patients receiving PERT consultations during the COVID-19 period compared to historical controls (mortality 14.9% vs 3.9%, = 0.18 and moderate-to-severe bleeding 35.1% vs 19.2%, = 0.13). In conclusion, PERT utilization was nearly threefold higher during the COVID-19 pandemic than during the historical control period. Among patients evaluated by PERT, in-hospital mortality or moderate-to-severe bleeding were not significantly different, despite being numerically higher, while invasive therapy was utilized less frequently during the COVID-19 pandemic.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1177/1358863X21995896DOI Listing
April 2021

Anatomic classification of mitral annular calcification for surgical and transcatheter mitral valve replacement.

J Card Surg 2021 Apr 2. Epub 2021 Apr 2.

Department of Cardiovascular Surgery, Mount Sinai Medical Center, New York, New York, USA.

BACKGROUND AND AIM OF THE STUDY: A systematic approach to quantify mitral annular calcification (MAC) in all-comers by multidetector computed tomography (MDCT) is essential to guide treatment, but lacking.

Methods: From September 2015 to July 2019, 82 patients with MAC underwent MDCT at two institutions to evaluate for surgical mitral valve replacement (SMVR), transcatheter mitral valve replacement (TMVR), or medical management. Type 1 MAC was defined as <270° annular calcium and Type 2 as ≥270°. Absence/presence of predicted left ventricular outflow tract (LVOT) obstruction with virtual valve placement was used to further define Type 2 MAC into 2A/B for our treatment algorithm.

Results: Type 1 MAC was present in 51.2%, Type 2A in 18.3%, and Type 2B in 30.5%. Operable Type 1 patients (50.0%) underwent hybrid transatrial TMVR or SMVR. Type 2A underwent a variety of treatments, and Type 2B surgical candidates (40.0%) underwent hybrid transatrial TMVR secondary to difficult suture anchoring with significant MAC and predicted LVOT obstruction. At a follow-up of 29.6 ± 12.0 months, mortality was 42.7% with 46.3% in the intervention group and 39.0% in the medical group (p = 0.47). All percutaneous TMVR patients expired. This translated to a disproportionate number of Type 2A deaths (80.0% with intervention), but all were high/extreme surgical risk. The hybrid TMVR group consisted of 95.0% Type 1/2B patients and had a lower Society of Thoracic Surgeons predicted risk of operative mortality (7.4% vs. 9.2%, p = 0.43)/mortality.

Conclusions: The highest mortality was seen in percutaneous TMVR Type 2A MAC patients, but they were at the greatest risk. Here we provide an objective MAC treatment algorithm for all-comers based on operability/anatomy.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1111/jocs.15535DOI Listing
April 2021

Atrial Fibrillation Is Associated With Mortality in Intermediate Surgical Risk Patients With Severe Aortic Stenosis: Analyses From the PARTNER 2A and PARTNER S3i Trials.

J Am Heart Assoc 2021 Apr 23;10(7):e019584. Epub 2021 Mar 23.

Division of Cardiology NewYork Presbyterian-Columbia University Medical Center New York NY.

Background The impact of atrial fibrillation (AF) in intermediate surgical risk patients with severe aortic stenosis who undergo either transcatheter or surgical aortic valve replacement (AVR) is not well established. Methods and Results Data were assessed in 2663 patients from the PARTNER (Placement of Aortic Transcatheter Valve) 2A or S3i trials. Analyses grouped patients into 3 categories according to their baseline and discharge rhythms (ie, sinus rhythm [SR]/SR, SR/AF, or AF/AF). Among patients with transcatheter AVR (n=1867), 79.2% had SR/SR, 17.6% had AF/AF, and 3.2% had SR/AF. Among patients with surgical AVR (n=796), 71.7% had SR/SR, 14.1% had AF/AF, and 14.2% had SR/AF. Patients with transcatheter AVR in AF at discharge had increased 2-year mortality (SR/AF versus SR/SR; hazard ratio [HR], 2.73; 95% CI, 1.68-4.44; <0.0001; AF/AF versus SR/SR; HR, 1.56; 95% CI, 1.16-2.09; =0.003); patients with SR/AF also experienced increased 2-year mortality relative to patients with AF/AF (HR, 1.77; 95% CI, 1.04-3.00; =0.03). For patients with surgicalAVR, the presence of AF at discharge was also associated with increased 2-year mortality (SR/AF versus SR/SR; HR, 1.93; 95% CI, 1.25-2.96; =0.002; and AF/AF versus SR/SR; HR, 1.67; 95% CI, 1.06-2.63; =0.027). Rehospitalization and persistent advanced heart failure symptoms were also more common among patients with transcatheter AVR and surgical AVR discharged in AF, and major bleeding was more common in the transcatheter AVR cohort. Conclusions The presence of AF at discharge in patients with intermediate surgical risk aortic stenosis was associated with worse outcomes-especially in patients with baseline SR-including increased all-cause mortality at 2-year follow-up. Registration URL: https://www.clinicaltrials.gov; Unique identifiers: NCT01314313 and NCT03222128.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1161/JAHA.120.019584DOI Listing
April 2021

Ischemia-Mediated Dysfunction in Subpapillary Myocardium as a Marker of Functional Mitral Regurgitation.

JACC Cardiovasc Imaging 2021 Apr 17;14(4):826-839. Epub 2021 Mar 17.

Division of Cardiology, Weill Cornell Medicine, New York, New York, USA. Electronic address:

Objectives: The goal of this study was to test whether ischemia-mediated contractile dysfunction underlying the mitral valve affects functional mitral regurgitation (FMR) and the prognostic impact of FMR.

Background: FMR results from left ventricular (LV) remodeling, which can stem from myocardial tissue alterations. Stress cardiac magnetic resonance can assess ischemia and infarction in the left ventricle and papillary muscles; relative impact on FMR is uncertain.

Methods: Vasodilator stress cardiac magnetic resonance was performed in patients with known or suspected coronary artery disease at 7 sites. Images were centrally analyzed for MR etiology/severity, mitral apparatus remodeling, and papillary ischemia.

Results: A total of 8,631 patients (mean age 60.0 ± 14.1 years; 55% male) were studied. FMR was present in 27%, among whom 16% (n = 372) had advanced (moderate or severe) FMR. Patients with ischemia localized to subpapillary regions were more likely to have advanced FMR (p = 0.003); those with ischemia localized to other areas were not (p = 0.17). Ischemic/dysfunctional subpapillary myocardium (odds ratio: 1.24/10% subpapillary myocardium; confidence interval: 1.17 to 1.31; p < 0.001) was associated with advanced FMR controlling for infarction. Among a subgroup with (n = 372) and without (n = 744) advanced FMR matched (1:2) on infarct size/distribution, patients with advanced FMR had increased adverse mitral apparatus remodeling, paralleled by greater ischemic/dysfunctional subpapillary myocardium (p < 0.001). Although posteromedial papillary ischemia was more common with advanced FMR (p = 0.006), subpapillary ischemia with dysfunction remained associated (p < 0.001), adjusting for posteromedial papillary ischemia (p = 0.074). During follow-up (median 5.1 years), 1,473 deaths occurred in the overall cohort; advanced FMR conferred increased mortality risk (hazard ratio: 1.52; 95% confidence interval: 1.25 to 1.86; p < 0.001) controlling for left ventricular ejection fraction, infarction, and ischemia.

Conclusions: Ischemic and dysfunctional subpapillary myocardium provides a substrate for FMR, which predicts mortality independent of key mechanistic substrates.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.jcmg.2021.01.007DOI Listing
April 2021

Surgical and Transcatheter Mitral Valve Replacement in Mitral Annular Calcification: A Systematic Review.

J Am Heart Assoc 2021 Apr 17;10(7):e018514. Epub 2021 Mar 17.

Department of Cardiovascular Surgery Mount Sinai Health System New York NY.

Mitral annular calcification with mitral valve disease is a challenging problem that could necessitate surgical mitral valve replacement (SMVR). Transcatheter mitral valve replacement (TMVR) is emerging as a feasible alternative in high-risk patients with appropriate anatomy. PubMed, Embase, and Cochrane Central Register of Controlled Trials were searched from inception to December 25, 2019 for studies discussing SMVR or TMVR in patients with mitral annular calcification; 27 of 1539 articles were selected for final review. TMVR was used in 15 studies. Relevant data were available on 82 patients who underwent hybrid transatrial TMVR, and 354 patients who underwent transapical or transseptal TMVR. Outcomes on SMVR were generally reported as small case series (447 patients from 11 studies); however, 1 large study recently reported outcomes in 9551 patients. Patients who underwent TMVR had a shorter median follow-up of 9 to 12 months (range, in-hospital‒19 months) compared with patients with SMVR (54 months; range, in-hospital‒120 months). Overall, those undergoing TMVR were older and had higher Society of Thoracic Surgeons risk scores. SMVR showed a wide range of early (0%-27%; median 6.3%) and long-term mortality (0%-65%; median at 1 year, 15.8%; 5 years, 38.8%, 10 years, 62.4%). The median in-hospital, 30-day, and 1-year mortality rates were 16.7%, 22.7%, and 43%, respectively, for transseptal/transapical TMVR, and 9.5%, 20.0%, and 40%, respectively, for transatrial TMVR. Mitral annular calcification is a complex disease and TMVR, with a versatile option of transatrial approach in patients with challenging anatomy, offers a promising alternative to SMVR in high-risk patients. However, further studies are needed to improve technology, patient selection, operative expertise, and long-term outcomes.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1161/JAHA.120.018514DOI Listing
April 2021

Sex Disparities in Patients with Symptomatic Severe Aortic Stenosis.

Am Heart J 2021 Mar 12. Epub 2021 Mar 12.

Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC. Electronic address:

Background: We evaluated whether there is equitable distribution across sexes of treatment and outcomes for aortic valve replacement (AVR), via surgical (SAVR) or transcatheter (TAVR) methods, in symptomatic severe aortic stenosis (ssAS) patients.

Methods: Using de-identified data, we identified 43,822 patients with ssAS (2008-2016). Multivariate competing risk models were used to determine the likelihood of any AVR, while accounting for the competing risk of death. Association between sex and one-year mortality, stratified by AVR status, was evaluated using multivariate Cox regression models with AVR as a time-dependent variable.

Results: Among patients with ssAS, 20,986 (47.9%) were female. Females were older (median age 81 vs. 78, p<0.001), more likely to have body mass index <20 (8.5% vs. 3.5%), and home oxygen use (4.4% vs. 3.4%, p<0001 for all). Overall, 12,129 (27.7%) patients underwent AVR for ssAS. Females were less likely to undergo AVR compared with males (24.1% vs. 31.0%, adjusted hazard ratio [HR] 0.80, 95% confidence interval [CI] 0.77-0.83), but when treated, were more likely to undergo TAVR (37.9% vs. 30.9%, adjusted HR 1.21, 95% CI 1.15-1.27). Untreated females and males had similarly high rates of mortality at one year (31.1% vs. 31.3%, adjusted HR 0.98, 95% CI 0.94-1.03). Among those undergoing AVR, females had significantly higher mortality (10.2% vs. 9.4%, adjusted HR 1.24, 95% CI 1.10-1.41), driven by increased SAVR-associated mortality (9.0% vs. 7.6%, adjusted HR 1.43, 95% CI 1.21-1.69).

Conclusions: Treatment rates for ssAS patients remain suboptimal with disparities in female treatment.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.ahj.2021.01.021DOI Listing
March 2021

Atrial Fibrillation and Outcomes After Transcatheter or Surgical Aortic Valve Replacement (from the PARTNER 3 Trial).

Am J Cardiol 2021 Mar 7. Epub 2021 Mar 7.

Cardiovascular Research Foundation, New York, New York; NewYork-Presbyterian Hospital/Columbia University Irving Medical Center, New York, New York. Electronic address:

The prognostic impact of preexisting atrial fibrillation or flutter (AF) in low-risk patients with severe aortic stenosis treated with transcatheter (TAVR) or surgical aortic valve replacement (SAVR) remains unknown. In this sub-analysis of the PARTNER 3 trial of patients with severe aortic stenosis at low surgical risk randomized 1:1 to TAVR versus SAVR, clinical outcomes were analyzed at 2 years according to AF status. Among 948 patients included in the analysis (452 [47.7%] in the SAVR vs 496 [52.3%] in the TAVR arm), 168 (17.6%) patients had AF [88/452 (19.5%) and 80/496 (16.1%) treated with SAVR and TAVR, respectively]. At 2 years, patients with AF had higher unadjusted rates of the composite outcome of death, stroke or rehospitalization (21.2% vs 12.9%, p = 0.007) and rehospitalization alone (15.3% vs 9.4%, p = 0.03) but not all cause death (3.8% vs 2.6%, p = 0.45) or stroke (4.8% vs 2.6%, p = 0.12). In adjusted analyses, patients with AF had a higher risk for the composite outcome of death, stroke or rehospitalization (hazard ratio [HR] 1.80, 95% confidence interval [CI] 1.20-2.71, p = 0.0046) and rehospitalization alone (HR 1.8, 95% CI 0.12-2.9, p = 0.015), but not death or stroke. There was no interaction between treatment modality and AF on the composite outcome (Pinter = 0.83). In conclusion, preexisting AF in patients with severe AS at low surgical risk was associated with increased risk of the composite outcome of death, stroke or rehospitalization at 2 years, irrespective of treatment modality.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.amjcard.2021.02.040DOI Listing
March 2021

Outcomes 2 Years After Transcatheter Aortic Valve Replacement in Patients at Low Surgical Risk.

J Am Coll Cardiol 2021 Mar;77(9):1149-1161

Department of Medicine, Laval University, Quebec, Quebec, Canada.

Background: In low surgical risk patients with symptomatic severe aortic stenosis, the PARTNER 3 (Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients With Aortic Stenosis) trial demonstrated superiority of transcatheter aortic valve replacement (TAVR) versus surgery for the primary endpoint of death, stroke, or re-hospitalization at 1 year.

Objectives: This study determined both clinical and echocardiographic outcomes between 1 and 2 years in the PARTNER 3 trial.

Methods: This study randomly assigned 1,000 patients (1:1) to transfemoral TAVR with the SAPIEN 3 valve versus surgery (mean Society of Thoracic Surgeons score: 1.9%; mean age: 73 years) with clinical and echocardiography follow-up at 30 days and at 1 and 2 years. This study assessed 2-year rates of the primary endpoint and several secondary endpoints (clinical, echocardiography, and quality-of-life measures) in this as-treated analysis.

Results: Primary endpoint follow-up at 2 years was available in 96.5% of patients. The 2-year primary endpoint was significantly reduced after TAVR versus surgery (11.5% vs. 17.4%; hazard ratio: 0.63; 95% confidence interval: 0.45 to 0.88; p = 0.007). Differences in death and stroke favoring TAVR at 1 year were not statistically significant at 2 years (death: TAVR 2.4% vs. surgery 3.2%; p = 0.47; stroke: TAVR 2.4% vs. surgery 3.6%; p = 0.28). Valve thrombosis at 2 years was increased after TAVR (2.6%; 13 events) compared with surgery (0.7%; 3 events; p = 0.02). Disease-specific health status continued to be better after TAVR versus surgery through 2 years. Echocardiographic findings, including hemodynamic valve deterioration and bioprosthetic valve failure, were similar for TAVR and surgery at 2 years.

Conclusions: At 2 years, the primary endpoint remained significantly lower with TAVR versus surgery, but initial differences in death and stroke favoring TAVR were diminished and patients who underwent TAVR had increased valve thrombosis. (Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients With Aortic Stenosis [PARTNER 3]; NCT02675114).
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.jacc.2020.12.052DOI Listing
March 2021

Impact of Coronary Artery Tortuosity on Outcomes Following Stenting: A Pooled Analysis From 6 Trials.

JACC Cardiovasc Interv 2021 Feb 20. Epub 2021 Feb 20.

Clinical Trials Center, Cardiovascular Research Foundation, New York, New York, USA; The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York, USA. Electronic address:

Objectives: The authors sought to determine whether coronary artery tortuosity negatively affects clinical outcomes after stent implantation.

Background: Coronary artery tortuosity is a common angiographic finding and has been associated with increased rates of early and late major adverse events after balloon angioplasty.

Methods: Individual patient data from 6 prospective, randomized stent trials were pooled. Outcomes at 30 days and 5 years following percutaneous coronary intervention of a single coronary lesion were analyzed according to the presence or absence of moderate/severe vessel tortuosity, as determined by an angiographic core laboratory. The primary endpoint was target vessel failure (TVF; composite of cardiac death, target vessel-related myocardial infarction [TV-MI], or ischemia-driven target vessel revascularization [ID-TVR]).

Results: A total of 6,951 patients were included, 729 of whom (10.5%) underwent percutaneous coronary intervention in vessels with moderate/severe tortuosity. At 30 days, TVF was more frequent in patients with versus without moderate/severe tortuosity (3.8% vs. 2.4%, hazard ratio: 1.64, 95% confidence interval: 1.09 to 2.46; p = 0.02), a difference driven by a higher rate of TV-MI. At 5 years, TVF remained increased in patients with moderate/severe tortuosity (p = 0.003), driven by higher rates of TV-MI (p = 0.003) and ID-TVR (p = 0.01). Definite stent thrombosis was also greater in patients with versus without moderate/severe tortuosity (1.9% vs. 1.0%, hazard ratio: 1.86, 95% confidence interval: 1.02 to 3.39; p = 0.04). After adjustment for baseline covariates, moderate/severe vessel tortuosity was independently associated with TV-MI and ID-TVR at 5 years (p = 0.04 for both).

Conclusions: Stent implantation in vessels with moderate/severe coronary artery tortuosity is associated with increased rates of TVF due to greater rates of TV-MI and ID-TVR.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.jcin.2020.12.027DOI Listing
February 2021

Association between antecedent statin use and decreased mortality in hospitalized patients with COVID-19.

Nat Commun 2021 02 26;12(1):1325. Epub 2021 Feb 26.

NewYork-Presbyterian Hospital and the Columbia University Irving Medical Center, New York, NY, USA.

The coronavirus disease 2019 (COVID-19) can result in a hyperinflammatory state, leading to acute respiratory distress syndrome (ARDS), myocardial injury, and thrombotic complications, among other sequelae. Statins, which are known to have anti-inflammatory and antithrombotic properties, have been studied in the setting of other viral infections, but their benefit has not been assessed in COVID-19. This is a retrospective analysis of patients admitted with COVID-19 from February 1 through May 12, 2020 with study period ending on June 11, 2020. Antecedent statin use was assessed using medication information available in the electronic medical record. We constructed a multivariable logistic regression model to predict the propensity of receiving statins, adjusting for baseline sociodemographic and clinical characteristics, and outpatient medications. The primary endpoint includes in-hospital mortality within 30 days. A total of 2626 patients were admitted during the study period, of whom 951 (36.2%) were antecedent statin users. Among 1296 patients (648 statin users, 648 non-statin users) identified with 1:1 propensity-score matching, statin use is significantly associated with lower odds of the primary endpoint in the propensity-matched cohort (OR 0.47, 95% CI 0.36-0.62, p < 0.001). We conclude that antecedent statin use in patients hospitalized with COVID-19 is associated with lower inpatient mortality.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1038/s41467-021-21553-1DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7910606PMC
February 2021

Transcatheter Tricuspid Valve Intervention in Patients with Previous Left Valve Surgery.

Can J Cardiol 2021 Feb 19. Epub 2021 Feb 19.

Cardiology Department, Quebec Heart and Lung Institute, Laval University, Quebec City, Canada. Electronic address:

Background: Scarce data exist on patients with previous left valve surgery (PLVS) undergoing transcatheter tricuspid valve intervention (TTVI).

Objectives: This study sought to investigate the procedural and early outcomes in patients with PLVS undergoing TTVI.

Methods: This was a sub-analysis of the multicenter TriValve registry including 462 patients, 82 (18%) with PLVS. Data were analyzed according to the presence of PLVS in the overall cohort and in a propensity score-matched population including 51 and 115 patients with and without PLVS, respectively.

Results: Patients with PLVS were younger (72±10 vs. 78±9 years, p <0.01) and more frequently women (67.1% vs 53.2%, p = 0.02). Similar rates of procedural success (PLVS: 80.5%, no-PLVS: 82.1%, p=0.73), and 30-day mortality (PLVS:2.4%, no-PLVS:3.4% , p=0.99 ) were observed. After matching, there were no significant differences in both all-cause rehospitalization (PLVS: 21.1%, non-PLVS: 26.5%, p=0.60) and all-cause mortality (PLVS: 9.8%, non-PLVS: 6.7%, p=0.58). At last follow-up (median time 5.7 [1.4-11.9] months after the procedure), most patients (81.8%) in the PLVS group were in NYHA class I-II (p= 0.12 vs. no-PLVS group), and TR grade was ≤2 in 82.6% of patients (p= 0.096 vs. no-PVLS group).

Conclusions: In patients with PLVS, TTVI was associated with high rates of procedural success and low early mortality. However, about one third of patients required rehospitalization or died at midterm follow-up. These results would support TTVI as a reasonable alternative to redo-surgery in patients with PLVS, and suggest the importance of earlier treatment in order to improve clinical outcomes.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.cjca.2021.02.010DOI Listing
February 2021

Outcomes of Retrograde Approach for Chronic Total Occlusions by Guidewire Location.

EuroIntervention 2021 Feb 16. Epub 2021 Feb 16.

Clinical Trials Center, Cardiovascular Research Foundation, New York, NY, USA.

Background: Connecting antegrade wire (AW) and retrograde wire (RW) is a goal of chronic total occlusion (CTO) treatment, but angiographic guide wire location is sometimes misleading.

Aims: To evaluate the association between intravascular ultrasound (IVUS) defined AW and RW position and procedural outcomes when treating CTO lesions using retrograde approach.

Methods: Overall, 191 CTO lesions treated with IVUS-guided retrograde approach at three centers in Japan, China, and United States were included.

Results: When the AW and RW angiographically overlapped, four wire positions were seen by IVUS: (i) AW within the plaque (AW-intraplaque) and RW-intraplaque in 34%; (ii) AW-intraplaque and RW in the subintimal space (RW-subintima) in 28%; (iii) AW-subintima and RW-subintima in 22%; or (iv) AW-subintima and RW-intraplaque in 16%. The procedure succeeded without repositioning the wire in 89% of AW-intraplaque/RW-intraplaque, 61% of AW-intraplaque/RW-subintima and 57% of AW-subintima/RW-subintima, but only one (3%) AW-subintima/RW-intraplaque. Lesion and procedure complexity and failure/complications were greatest in AW-subintima/RW-intraplaque.

Conclusions: IVUS-identified vascular compartment concordance versus IVUS-identified vascular compartment mismatch leads to higher success rates irrespective of intra-plaque or sub-intimal passage . AW-subintima/RW-intraplaque was associated with the most complex CTO morphology and procedure and repositioning the wire was almost always necessary.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.4244/EIJ-D-20-01169DOI Listing
February 2021

Transfemoral Transcatheter Tricuspid Valve Replacement With the EVOQUE System: A Multicenter, Observational, First-in-Human Experience.

JACC Cardiovasc Interv 2021 Mar 10;14(5):501-511. Epub 2021 Feb 10.

St. Paul's Hospital, Centre for Heart Valve Innovation, University of British Columbia, Vancouver, British Columbia, Canada.

Objectives: The purpose of this observational first-in-human experience was to investigate the feasibility and safety of the EVOQUE tricuspid valve replacement system and its impact on short-term clinical outcomes.

Background: Transcatheter tricuspid intervention is a promising option for selected patients with severe tricuspid regurgitation (TR). Although transcatheter leaflet repair is an option for some, transcatheter tricuspid valve replacement (TTVR) may be applicable to a broader population.

Methods: Twenty-five patients with severe TR underwent EVOQUE TTVR in a compassionate-use experience. The primary outcome was technical success, with NYHA (NYHA) functional class, TR grade, and major adverse cardiac and cerebrovascular events assessed at 30-day follow-up.

Results: All patients (mean age 76 ± 3 years, 88% women) were at high surgical risk (mean Society of Thoracic Surgeons risk score 9.1 ± 2.3%), with 96% in NYHA functional class III or IV. TR etiology was predominantly functional, with mean tricuspid annular diameter of 44.8 ± 7.8 mm and mean tricuspid annular plane systolic excursion of 16 ± 2 mm. Technical success was 92%, with no intraprocedural mortality or conversion to surgery. At 30-day follow-up, mortality was 0%, 76% of patients were in NYHA functional class I or II, and TR grade was ≤2+ in 96%. Major bleeding occurred in 3 patients (12%), 2 patients (8%) required pacemaker implantation, and 1 patient (4%) required dialysis.

Conclusions: This first-in-human experience evaluating EVOQUE TTVR demonstrated high technical success, acceptable safety, and significant clinical improvement. Larger prospective studies are needed to confirm durability and safety and the impact on long-term clinical outcomes.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.jcin.2020.11.045DOI Listing
March 2021

Transcatheter Tricuspid Valve Intervention in Patients With Right Ventricular Dysfunction or Pulmonary Hypertension: Insights From the TriValve Registry.

Circ Cardiovasc Interv 2021 Feb 5;14(2):e009685. Epub 2021 Feb 5.

Cardiology Department, Quebec Heart and Lung Institute, Laval University, Quebec City, Canada (G.M.-C., F. Philippon, R.P., J.R.-C.).

Background: Scarce data exist on patients with right ventricular dysfunction (RVD) or pulmonary hypertension (PH) undergoing transcatheter tricuspid valve intervention. This study aimed to determine the early and midterm outcomes and the factors associated with mortality in this group of patients.

Methods: This subanalysis of the multicenter TriValve (Transcatheter Tricuspid Valve Therapies) registry included 300 patients with severe tricuspid regurgitation with RVD (n=244), PH (n=127), or both (n=71) undergoing transcatheter tricuspid valve intervention. RVD was defined as a tricuspid annular plane systolic excursion <17 mm, and PH as an estimated pulmonary artery systolic pressure ≥50 mm Hg.

Results: Mean age of the patients was 77±9 years (54% women). Procedural success was 80.7%, and 9 patients (3%) died during the hospitalization. At a median follow-up of 6 (interquartile range, 2-12) months, 54 patients (18%) died, and the independent associated factors were higher gamma-glutamyl transferase values at baseline (hazard ratio, 1.02 for each increase of 10 u/L [95% CI, 1.002-1.04]), poorer renal function defined as an estimated glomerular filtration rate <45 mL/min (hazard ratio, 2.3 [95% CI, 1.22-4.33]), and the lack of procedural success (hazard ratio, 2.11 [95% CI, 1.17-3.81]). The grade of RVD and the amount of PH at baseline were not found to be predictors of mortality. Most patients alive at follow-up improved their functional class (New York Heart Association I-II in 66% versus 7% at baseline, <0.001).

Conclusions: In patients with severe tricuspid regurgitation and RVD/PH, transcatheter tricuspid valve intervention was associated with high procedural success and a relatively low in-hospital mortality, along with significant improvements in functional status. However, about 1 out of 5 patients died after a median follow-up of 6 months, with hepatic congestion, renal dysfunction, and the lack of procedural success determining an increased risk. These results may improve the clinical evaluation of transcatheter tricuspid valve intervention candidates and would suggest a closer follow-up in those at increased risk. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT03416166.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1161/CIRCINTERVENTIONS.120.009685DOI Listing
February 2021

Single versus dual antiplatelet therapy after transcatheter aortic valve replacement: a meta-analysis of randomized clinical trials.

Cardiovasc Revasc Med 2021 Jan 22. Epub 2021 Jan 22.

Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles, CA, USA.

Background: Guidelines recommend dual antiplatelet therapy (DAPT) after transcatheter aortic valve replacement (TAVR) but guidelines predate the publication of the largest randomized trial. There have been few trials in the field to date, and with a small number of total patients; pooling their results may therefore be helpful.

Methods: We systematically identified all randomized trials comparing SAPT to DAPT after TAVR. The primary endpoint was the risk of major bleeding. Secondary endpoints included all bleeding, life-threatening bleeding, stroke, myocardial infarction, death and cardiac death.

Results: Four trials, randomizing 1086 participants, were eligible (541 randomized to SAPT and 545 randomized to DAPT). The weighted mean follow-up was 9.1 months. The risk of major bleeding was significantly increased after DAPT (relative risk (RR) 2.36, 95% confidence interval (CI) 1.27 to 4.40, P = 0.007). There was a similar increased risk for all bleeding (RR 1.65, 95% CI 1.24 to 2.19, P < 0.001), although not for life-threatening bleeding (RR 1.44, 95% CI 0.74 to 2.77, P = 0.282). There were no significant differences in the risk of stroke, myocardial infarction (MI), death or cardiac death. There was no heterogeneity observed for any endpoint (I = 0.0%).

Conclusions: DAPT after TAVR is associated with an increased risk of major bleeding and all bleeding. There is no evidence of a significant difference between DAPT or SAPT for the risks of stroke, MI, death or cardiac death. However, the total number of patients randomized is small and the duration of follow-up is short. Larger scale randomized trials with longer follow-up are required to assess for any potential differences in ischemic endpoints or mortality.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.carrev.2021.01.016DOI Listing
January 2021

Feasibility Study of the Transcatheter Valve Repair System for Severe Tricuspid Regurgitation.

J Am Coll Cardiol 2021 Feb;77(4):345-356

Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA.

Background: Tricuspid regurgitation (TR) is a prevalent disease with limited treatment options.

Objectives: This is the first 30-day report of the U.S. single-arm, multicenter, prospective CLASP TR early feasibility study of the PASCAL transcatheter valve repair system in the treatment of TR.

Methods: Patients with symptomatic TR despite optimal medical therapy, reviewed by the local heart team and central screening committee, were eligible for the study. Data were collected at baseline, discharge, and the 30-day follow-up and were reviewed by an independent clinical events committee and echocardiographic core laboratory. Feasibility endpoints included safety (composite major adverse event [MAE] rate), echocardiographic, clinical, and functional endpoints.

Results: Of the 34 patients enrolled in the study, the mean age was 76 years, 53% were women, the mean Society of Thoracic Surgeons score was 7.3%, 88% had atrial fibrillation/flutter, 97% had severe or greater TR, and 79% had New York Heart Association (NYHA) functional class III/IV symptoms. Twenty-nine patients (85%) received implants; at 30 days, 85% of them achieved a TR severity reduction of at least 1 grade, with 52% with moderate or less TR (p < 0.001). The MAE rate was 5.9%, and none of the patients experienced cardiovascular mortality, stroke, myocardial infarction, renal complication, or reintervention. Eighty-nine percent of the patients improved to NYHA functional class I/II (p < 0.001), the mean 6-min walk distance improved by 71 m (p < 0.001), and the mean Kansas City Cardiomyopathy Questionnaire score improved by 15 points (p < 0.001).

Conclusions: In this early experience, the repair system performed as intended, with substantial TR reduction, favorable safety results with a low MAE rate, no mortality or reintervention, and significant improvements in functional status, exercise capacity, and quality of life. (Edwards CLASP TR EFS [CLASP TR EFS]; NCT03745313).
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.jacc.2020.11.047DOI Listing
February 2021

The International Society for Minimally Invasive Cardiothoracic Surgery Expert Consensus Statement on Transcatheter and Surgical Aortic Valve Replacement in Low- and Intermediate-Risk Patients: A Meta-Analysis of Randomized and Propensity-Matched Studies.

Innovations (Phila) 2021 Jan-Feb;16(1):3-16. Epub 2021 Jan 25.

12264 Division of Cardiac Surgery, University of Maryland School of Medicine, Baltimore, MD, USA.

Objective: There is an increasing amount of evidence supporting use of transcatheter aortic valve replacement (TAVR) for treatment of aortic stenosis in patients at low or intermediate risk for surgical aortic valve replacement (SAVR). TAVR is now approved for use in all patient cohorts. Despite this, there remains debate about the relative efficacy of TAVR compared with SAVR in lower-risk cohorts and various subgroups of patients. We performed a systematic review and meta-analysis of randomized controlled trials (RCTs) and propensity-matched trials to guide a consensus among expert cardiologists and surgeons.

Methods: Studies comparing TAVR and SAVR in low- and intermediate-risk patients were identified by a thorough search of the major databases. Mortality, stroke, and other perioperative outcomes were assessed at 30 days and 1 year.

Results: Early mortality was lower in TAVR compared to SAVR in RCTs, but not propensity-matched studies in low-risk cohorts (0.66% vs 1.5%; odds ratio [OR] = 0.44, 95% confidence interval [CI] 0.20 to 0.98, = 0%). No difference in mortality between TAVR and SAVR was identified in intermediate-risk patients at early or later time points. Incidence of perioperative stroke in 3 low-risk RCTs was significantly lower in TAVR (0.4%) than SAVR (1.4%; OR = 0.33, 95% CI 0.13 to 0.81, = 0%). There was no difference in stroke for intermediate-risk patients between TAVR and SAVR. The expert panel of cardiologists and cardiac surgeons provided recommendations for TAVR and SAVR in various clinical scenarios.

Conclusions: In RCTs comparing TAVR and SAVR in low-risk patients, early mortality and stroke were lower in TAVR, but did not differ at 1 year. There was no difference in mortality and stroke in intermediate-risk patients. The Multidisciplinary Heart Team must consider individual patient characteristics and preferences when recommending TAVR or SAVR. The decision must consider the long-term management of each patient's aortic valve disease.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1177/1556984520978316DOI Listing
January 2021

Transcatheter Replacement of Transcatheter Versus Surgically Implanted Aortic Valve Bioprostheses.

J Am Coll Cardiol 2021 Jan;77(1):1-14

Centres for Heart Valve and Cardiovascular Innovation, St. Paul's and Vancouver General Hospital, Vancouver, British Columbia, Canada. Electronic address:

Background: Surgical aortic valve replacement and transcatheter aortic valve replacement (TAVR) are now both used to treat aortic stenosis in patients in whom life expectancy may exceed valve durability. The choice of initial bioprosthesis should therefore consider the relative safety and efficacy of potential subsequent interventions.

Objectives: The aim of this study was to compare TAVR in failed transcatheter aortic valves (TAVs) versus surgical aortic valves (SAVs).

Methods: Data were collected on 434 TAV-in-TAV and 624 TAV-in-SAV consecutive procedures performed at centers participating in the Redo-TAVR international registry. Propensity score matching was applied, and 330 matched (165:165) patients were analyzed. Principal endpoints were procedural success, procedural safety, and mortality at 30 days and 1 year.

Results: For TAV-in-TAV versus TAV-in-SAV, procedural success was observed in 120 (72.7%) versus 103 (62.4%) patients (p = 0.045), driven by a numerically lower frequency of residual high valve gradient (p = 0.095), ectopic valve deployment (p = 0.081), coronary obstruction (p = 0.091), and conversion to open heart surgery (p = 0.082). Procedural safety was achieved in 116 (70.3%) versus 119 (72.1%) patients (p = 0.715). Mortality at 30 days was 5 (3%) after TAV-in-TAV and 7 (4.4%) after TAV-in-SAV (p = 0.570). At 1 year, mortality was 12 (11.9%) and 10 (10.2%), respectively (p = 0.633). Aortic valve area was larger (1.55 ± 0.5 cm vs. 1.37 ± 0.5 cm; p = 0.040), and the mean residual gradient was lower (12.6 ± 5.2 mm Hg vs. 14.9 ± 5.2 mm Hg; p = 0.011) after TAV-in-TAV. The rate of moderate or greater residual aortic regurgitation was similar, but mild aortic regurgitation was more frequent after TAV-in-TAV (p = 0.003).

Conclusions: In propensity score-matched cohorts of TAV-in-TAV versus TAV-in-SAV patients, TAV-in-TAV was associated with higher procedural success and similar procedural safety or mortality.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.jacc.2020.10.053DOI Listing
January 2021

Bleeding Outcomes in Patients Undergoing Combined Percutaneous Coronary Interventions+Transcatheter Aortic Valve Replacement: Time for an Adjustment to the CathPCI Bleeding Model?

Circ Cardiovasc Interv 2021 Jan 23;14(1):e009806. Epub 2020 Dec 23.

Division of Cardiovascular Medicine, Columbia University Irving Medical Center, New York (A.G., M.L., E.S., T.P.V., M.F., K.F., T.N., M.B.L., S.K.K., A.J.K.).

View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1161/CIRCINTERVENTIONS.120.009806DOI Listing
January 2021

Impella percutaneous left ventricular assist device as mechanical circulatory support for cardiogenic shock: A retrospective analysis from a tertiary academic medical center.

Catheter Cardiovasc Interv 2020 Dec 16. Epub 2020 Dec 16.

Division of Cardiology, Department of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts, USA.

Objectives: To describe hemodynamic efficacy and clinical outcomes of Impella percutaneous left ventricular assist device (pLVAD) in patients with cardiogenic shock (CS).

Background: Percutaneous LVADs are increasingly used in CS management. However, device-related outcomes and optimal utilization remain active areas of investigation.

Methods: All CS patients receiving pLVAD as mechanical circulatory support (MCS) between 2011 and 2017 were identified. Clinical characteristics and outcomes were analyzed. A multivariable logistic regression model was created to predict MCS escalation despite pLVAD. Outcomes were compared between early and late implantation.

Results: A total of 115 CS patients (mean age 63.6 ± 13.8 years; 69.6% male) receiving pLVAD as MCS were identified, the majority with CS secondary to acute myocardial infarction (AMI; 67.0%). Patients experienced significant cardiac output improvement (median 3.39 L/min to 3.90 L/min, p = .002) and pharmacological support reduction (median vasoactive-inotropic score [VIS] 25.4 to 16.4, p = .049). Placement of extracorporeal membrane oxygenation (ECMO) occurred in 48 (41.7%) of patients. Higher pre-pLVAD VIS was associated with subsequent MCS escalation in the entire cohort and AMI subgroup (OR 1.27 [95% CI 1.02-1.58], p = .034 and OR 1.72 [95% CI 1.04-2.86], p = .035, respectively). Complications were predominantly access site related (bleeding [9.6%], vascular injury [5.2%], and limb ischemia [2.6%]). In-hospital mortality was 57.4%, numerically greater survival was noted with earlier device implantation.

Conclusions: Treatment with pLVAD for CS improved hemodynamic status but did not uniformly obviate MCS escalation. Mortality in CS remains high, though earlier device placement for appropriately selected patients may be beneficial.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1002/ccd.29434DOI Listing
December 2020

Early Feasibility Studies for Cardiovascular Devices in the United States: JACC State-of-the-Art Review.

J Am Coll Cardiol 2020 12;76(23):2786-2794

Department of Cardiovascular Surgery, Baylor Health Care System, and Baylor Scott and White-The Heart Hospital-Plano Research Center, Plano, Texas.

The development of technology to treat unmet clinical patient needs in the United States has been an important focus for the U.S. Food and Drug Administration and the 2016 Congressional 21st Century Cures Act. In response, a program of early feasibility studies (EFS) has been developed. One of the important issues has been the outmigration of the development and testing of medical devices from the United States. The EFS committee has developed and implemented processes to address issues to develop strategies for early treatment of these patient groups. Initial implementation of the U.S. Food and Drug Administration EFS program has been successful, but residual significant problems have hindered the opportunity to take full advantage of the program. These include delays in gaining Institutional Review Board approval, timeliness of budget and contractual negotiations, and lack of access to and enrollment of study subjects. This paper reviews improvements that have been made to the U.S. EFS ecosystem and outlines potential approaches to address remaining impediments to program success.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.jacc.2020.10.019DOI Listing
December 2020

Brain Injury After Transcatheter Replacement of Bicuspid Versus Tricuspid Aortic Valves.

J Am Coll Cardiol 2020 12;76(22):2579-2590

Columbia University Medical Center, New York, New York; Cardiovascular Research Foundation, New York, New York.

Background: An increasing number of bicuspid aortic valve (BAV) patients are undergoing transcatheter aortic valve replacement (TAVR), but the risk of brain injury in diffusion-weighted magnetic resonance imaging (DW-MRI) is currently unknown.

Objectives: This study sought to evaluate the risk of brain injury in BAV patients following TAVR.

Methods: A total of 204 consecutive severe aortic stenosis patients who underwent TAVR were enrolled. A total of 83 (40.7%) patients were BAV patients, and the other 121 patients were tricuspid aortic valve (TAV) patients. All patients received DW-MRI at baseline, and after TAVR.

Results: Median ages (76 years [interquartile range (IQR): 71 to 81 years] vs. 79 years [IQR: 74 to 83 years]; p = 0.004) and Society of Thoracic Surgeons scores (4.87 [IQR: 3.72 to 8.54] vs. 6.38 [IQR: 3.96 to 9.50]; p = 0.044) of the BAV and TAV patients were significantly different, while the overt stroke rates (2.4% vs. 1.7%; p = 0.704) were comparable between the 2 groups. BAV patients were associated with higher number of new lesions (4.0 [IQR: 1.0 to 8.0] vs. 2.0 [IQR: 1.0 to 5.0]; p = 0.008), total lesion volume (290 mm [IQR: 70 to 930 mm] vs. 140 mm [IQR: 35 to 480 mm]; p = 0.008), and the volume per lesion (70.0 mm [IQR: 45.0 to 115.0 mm] vs. 57.5 mm [IQR: 24.5 to 93.0 mm]; p = 0.037) in DW-MRI. Moreover, the proportion of patients with lesions larger than 1 cm (28.6% vs. 10.9%; p = 0.005) was higher in BAV patients than in TAV patients.

Conclusions: BAV patients may encounter more severe brain injuries not only due to greater number of lesions, but also due to larger lesion size in the early phase after TAVR. (Transcatheter Aortic Valve Replacement Single Center Registry in Chinese Population [TORCH]; NCT02803294).
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.jacc.2020.09.605DOI Listing
December 2020

Admission Cardiac Diagnostic Testing with Electrocardiography and Troponin Measurement Prognosticates Increased 30-Day Mortality in COVID-19.

J Am Heart Assoc 2021 01 10;10(1):e018476. Epub 2020 Nov 10.

Seymour, Paul, and Gloria Milstein Division of Cardiology Department of Medicine Columbia University Irving Medical Center New York NY.

Background Cardiovascular involvement in coronavirus disease 2019 (COVID-19) is common and leads to worsened mortality. Diagnostic cardiovascular studies may be helpful for resource appropriation and identifying patients at increased risk for death. Methods and Results We analyzed 887 patients (aged 64±17 years) admitted with COVID-19 from March 1 to April 3, 2020 in New York City with 12 lead electrocardiography within 2 days of diagnosis. Demographics, comorbidities, and laboratory testing, including high sensitivity cardiac troponin T (hs-cTnT), were abstracted. At 30 days follow-up, 556 patients (63%) were living without requiring mechanical ventilation, 123 (14%) were living and required mechanical ventilation, and 203 (23%) had expired. Electrocardiography findings included atrial fibrillation or atrial flutter (AF/AFL) in 46 (5%) and ST-T wave changes in 306 (38%). 27 (59%) patients with AF/AFL expired as compared to 181 (21%) of 841 with other non-life-threatening rhythms (<0.001). Multivariable analysis incorporating age, comorbidities, AF/AFL, QRS abnormalities, and ST-T wave changes, and initial hs-cTnT ≥20 ng/L showed that increased age (HR 1.04/year), elevated hs-cTnT (HR 4.57), AF/AFL (HR 2.07), and a history of coronary artery disease (HR 1.56) and active cancer (HR 1.87) were associated with increased mortality. Conclusions Myocardial injury with hs-cTnT ≥20 ng/L, in addition to cardiac conduction perturbations, especially AF/AFL, upon hospital admission for COVID-19 infection is associated with markedly increased risk for mortality than either diagnostic abnormality alone.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1161/JAHA.120.018476DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7955502PMC
January 2021

Coronary Cannulation After Transcatheter Aortic Valve Replacement: The RE-ACCESS Study.

JACC Cardiovasc Interv 2020 11 14;13(21):2542-2555. Epub 2020 Oct 14.

Division of Cardiology, A.O.U. Policlinico-San Marco, Catania, Italy.

Objectives: The aims of this study were to investigate the feasibility of coronary ostia cannulation after transcatheter aortic valve replacement (TAVR) and to assess potential predictors of coronary access impairment.

Background: Certain data concerning the feasibility and reproducibility of coronary cannulation after TAVR are lacking.

Methods: RE-ACCESS (Reobtain Coronary Ostia Cannulation Beyond Transcatheter Aortic Valve Stent) was an investigator-driven, single-center, prospective, registry-based study that enrolled consecutive patients undergoing TAVR using all commercially available devices. All patients underwent coronary angiography before and after TAVR. The primary endpoint was the rate of unsuccessful coronary ostia cannulation after TAVR. Secondary endpoints were the identification of factors associated with the inability to selectively cannulate coronary ostia after TAVR.

Results: Among 300 patients enrolled in the RE-ACCESS study from December 2018 to January 2020, a total of 23 cases (7.7%) of unsuccessful coronary cannulation after TAVR were documented. This issue occurred in 22 of 23 cases with the use of Evolut R/PRO transcatheter aortic valves (TAVs) (17.9% vs. 0.4%; p < 0.01). In multivariate analysis, the use of Evolut R/PRO TAVs (odds ratio [OR]: 29.6; 95% confidence interval [CI]: 2.6 to 335.0; p < 0.01), the TAV-sinus of Valsalva relation (OR: 1.1 per 1-mm increase; 95% CI: 1.0 to 1.2; p < 0.01), and the mean TAV implantation depth (OR: 1.7 per 1-mm decrease; 95% CI: 1.3 to 2.3; p < 0.01) were found to be independent predictors of unsuccessful coronary cannulation after TAVR. A model combining these factors was demonstrated to predict with very high accuracy the risk for unsuccessful coronary cannulation after TAVR (area under the curve: 0.94; p < 0.01).

Conclusions: Unsuccessful coronary cannulation following TAVR was observed in 7.7% of patients and occurred almost exclusively in those receiving Evolut TAVs. The combination of Evolut TAV, a higher TAV-sinus of Valsalva relation, and implantation depth predicts with high accuracy the risk for unsuccessful coronary cannulation after TAVR. (Reobtain Coronary Ostia Cannulation Beyond Transcatheter Aortic Valve Stent [RE-ACCESS]; NCT04026204).
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.jcin.2020.07.006DOI Listing
November 2020

Incidence, Characteristics, Predictors, and Outcomes of Surgical Explantation After Transcatheter Aortic Valve Replacement.

J Am Coll Cardiol 2020 10;76(16):1848-1859

Division of Cardiac Surgery, Department of Surgery, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts. Electronic address:

Background: Currently, there is a paucity of information on surgical explantation after transcatheter aortic valve replacement (TAVR).

Objectives: The purpose of this study was to examine the incidence, patient characteristics, predictors, and outcomes of surgical explantation after TAVR using a population-based, nationally representative database.

Methods: We analyzed the Medicare Provider profile to include all U.S. patients undergoing TAVR from 2012 to 2017. Time to surgical explant was calculated from the index TAVR discharge to surgical explantation. Post-operative survival was assessed using time-dependent Cox proportional hazard regression analysis and landmark analysis.

Results: The incidence of surgical explantation was 0.2% (227 of 132,633 patients), and was 0.28% and 0.14% in the early and newer TAVR era, respectively. The median time to surgical explant was 212 days, whereas 8.8% and 70.9% underwent surgical explantation within 30 days and 1 year, respectively. The primary indication for reintervention was bioprosthetic failure (79.3%). Compared with the no-explant cohort, the explant cohort was significantly younger (mean age 73.7 years vs. 81.7 years), with a lower prevalence of heart failure (55.9% vs. 65.8%) but more likely a lower-risk profile cohort (15% vs. 2.4%; all p < 0.05). The 30-day and 1-year mortality rates were 13.2% and 22.9%, respectively, and did not vary by either time to surgical explant or TAVR era, or between patients with versus without endocarditis (all p > 0.05). The time-dependent Cox regression analysis demonstrated a higher mortality in those with surgical explantation (hazard ratio: 4.03 vs. no-explant group; 95% confidence interval: 1.81 to 8.98). Indication, time-to-surgical-explant, and year of surgical explantation were not associated with worse post-explantation survival (all p > 0.05).

Conclusions: The present study provides updated evidence on the incidence, timing, and outcomes of surgical explantation of a TAVR prosthesis. Although the overall incidence was low, short-term mortality was high. These findings stress the importance of future mechanistic studies on TAVR explantation and may have implications on lifetime management of aortic stenosis, particularly in younger patients.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.jacc.2020.08.048DOI Listing
October 2020