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Review of Interventional Late Breaking Trials From AHA Scientific Sessions 2020 Virtual Meeting

Medranda, Giorgio A; Case, Brian C; Wermers, Jason P; Morrison, Natalie; Yerasi, Charan; Forrestal, Brian J; Chezar-Azerrad, Chava; Waksman, Ron
PMCID:7919504
PMID: 34049820
ISSN: 1878-0938
CID: 5155382

Review of Coronary Late Breaking Trials From the TCT Connect 2020 Virtual Meeting

Medranda, Giorgio A; Case, Brian C; Wermers, Jason P; Morrison, Natalie; Yerasi, Charan; Forrestal, Brian; Chezar-Azerrad, Chava; Waksman, Ron
PMCID:8065258
PMID: 33707152
ISSN: 1878-0938
CID: 5155292

Review of Imaging and Physiology Late Breaking Trials From the TCT Connect 2020 Virtual Meeting

Medranda, Giorgio A; Case, Brian C; Wermers, Jason P; Morrison, Natalie; Yerasi, Charan; Forrestal, Brian; Chezar-Azerrad, Chava; Waksman, Ron
PMCID:7780069
PMID: 33712399
ISSN: 1878-0938
CID: 5155302

Review of Late-Breaking Trials From CRT 2021 Virtual

Medranda, Giorgio A; Case, Brian C; Wermers, Jason P; Morrison, Natalie; Waksman, Ron
PMCID:7986312
PMID: 33903040
ISSN: 1878-0938
CID: 5155332

Transcatheter aortic valve replacement in low-risk patients: 2-year results from the LRT trial

Waksman, Ron; Torguson, Rebecca; Medranda, Giorgio A; Shea, Corey; Zhang, Cheng; Gordon, Paul; Ehsan, Afshin; Wilson, Sean R; Levitt, Robert; Hahn, Chiwon; Parikh, Puja; Bilfinger, Thomas; Butzel, David; Buchanan, Scott; Hanna, Nicholas; Buchbinder, Maurice; Asch, Federico; Weissman, Gaby; Ben-Dor, Itsik; Shults, Christian; Garcia-Garcia, Hector M; Satler, Lowell F; Rogers, Toby
BACKGROUND:Previous studies from the Low Risk TAVR (LRT) trial demonstrated that transcatheter aortic valve replacement (TAVR) is safe and feasible in low-risk patients, with excellent 30-day and 1-year outcomes. The objective of this study was to report clinical outcomes and the impact of 30-day hypoattenuated leaflet thickening (HALT) on structural valve deterioration (SVD) 2 years after TAVR. METHODS:The LRT trial was the first Food and Drug Administration-approved Investigational Device Exemption trial in the United States to evaluate the safety and feasibility of TAVR in low-risk patients with symptomatic severe tricuspid aortic stenosis (AS). Valve hemodynamics and SVD by echo were recorded 30 days, 1 year, and 2 years post-TAVR. RESULTS:The LRT trial enrolled 200 low-risk patients to receive TAVR. Their mean age was 73.6 years and 61.5% were men. At 2-year follow-up, the mortality rate was 4.2%; the cardiovascular death rate was 1.6%. The disabling stroke rate was 1.1%, permanent pacemaker implantation rate was 8.6%, and 4 patients (2.2%) presented with endocarditis (2 between years 1 and 2). Of the 14% of TAVR subjects who had evidence of HALT at 30 days, there was no impact on valve hemodynamics, endocarditis or stroke at 2 years. CONCLUSIONS:TAVR for low-risk patients with symptomatic severe tricuspid AS is safe at 2 years. The presence of HALT at 30 days did not impact the early hemodynamic improvements nor the durability of the valve structure.
PMID: 33713618
ISSN: 1097-6744
CID: 5155312

Review of Structural Late Breaking Trials From the TCT Connect 2020 Virtual Meeting

Medranda, Giorgio A; Case, Brian C; Wermers, Jason P; Morrison, Natalie; Yerasi, Charan; Forrestal, Brian; Chezar-Azerrad, Chava; Waksman, Ron
PMID: 33707151
ISSN: 1878-0938
CID: 5155282

Elevated Baseline B-Type Natriuretic Peptide Predicts Mortality in Transcatheter Aortic Valve Replacement [Meeting Abstract]

Medranda, G A; Brahmbhatt, K; Alawneh, B; Salhab, K; Schwartz, R K; Green, S J
Background: B-type natriuretic peptide (BNP) has been established as a predictor of outcomes in patients who undergo surgical aortic valve replacement (SAVR). Studies on the prognostic value of BNP in high-risk patients undergoing transcatheter aortic valve replacement (TAVR) have yielded conflicting results. Additionally, BNP has not been well-studied in low- and intermediate-risk patients undergoing TAVR. The purpose of this study was to clarify the prognostic utility of baseline BNP in low-, intermediate-, and high-risk patients with severe aortic stenosis (AS) undergoing TAVR.
Method(s): This was a retrospective observational study of 1544 low-, intermediate-, and high-risk patients who underwent TAVR at our institution from 2012-2019. Included were patients who had a BNP <7 days prior to TAVR. Patients were then trichotomized into those with a pre-TAVR BNP <250 pg/mL (cohort 1), between 250-500 pg/mL (cohort 2), and >500 pg/mL (cohort 3). Outcomes of interest were inpatient and 30-day mortality. Statistical analyses of outcomes were performed using multivariate binary logistic regression.
Result(s): Of the 1544 patients screened, 1487 patients had a BNP level <7 days prior to TAVR and thus were included in the study. Patients in cohort 3 with a baseline BNP >500 pg/mL were 3.31 times more likely to have inpatient death (CI 0.142, 0.643; P=0.0019), 2.70 times more likely to have death within 30 days (CI 0.192, 0.711; P=0.0029) and 1.81 times more likely to have death within 1 year (CI 0.348, 0.880, p=0.0152).
Conclusion(s): Our study of 1487 low-, intermediate-, and high-risk patients demonstrates a baseline BNP greater than 500 pg/mL is an independent predictor of inpatient, 30-day and 1-year mortality. BNP has prognostic implications in TAVR patients across all risk groups and can help identify the subset of patients who may warrant closer follow up following TAVR.
Copyright
EMBASE:2014132598
ISSN: 1878-0938
CID: 4987362

Long-Term Outcomes Following Transcatheter Mitral Valve Replacement For The Treatment Of Degenerated Mitral Bioprostheses [Meeting Abstract]

Medranda, G A; Brahmbhatt, K; Schwartz, R K; Green, S J
Background: The advent of transcatheter aortic valve replacement (TAVR) has ignited the search for a mitral equivalent. Ongoing trials will attempt to design a safe and effective transcatheter mitral valve replacement (TMVR) device. In the interim, the US Food and Drug Administration has approved the balloon-expandable transcatheter heart valve system for the treatment of degenerated mitral bioprostheses. The purpose of this study was to detail the short- and long-term outcomes of high-risk patients undergoing TMVR at our institution.
Method(s): In this retrospective observational study, we reviewed data on the first 26 patients with previous surgical mitral valve replacement (MVR, 76.9%) or repair with ring (23.1%) who underwent TMVR using the third-generation transcatheter balloon-expandable valve at NYU Langone Hospital - Long Island from 2015 through 2019. We reviewed pre-/post-TMVR echocardiographic data, inpatient, 30-day, and 1-year data. Statistical analysis was performed using Student's t-test and Wilcoxon signed rank test.
Result(s): Of the 26 patients, the primary indication for TMVR was bioprosthetic valve regurgitation in 9 patients, bioprosthetic transvalvular stenosis in 9 patients, and mixed mitral disease in 8 patients. The average Society of Thoracic Surgeons score for MVR was 13.0%. Of the 26 TMVRs, 19 were transseptal and 7 were transapical. There was a 100% device implantation success rate and a 96.2% inpatient survival rate. At 30 days, there was a 96% survival rate. Mitral valve mean gradient (13.3 mmHg to 6.8 mmHg, p < 0.0001) and mitral regurgitation (3+ to 1+, p < 0.0001) showed significant improvement after TMVR. There were significant 30-day and 1-year improvements in patients' Kansas City Cardiomyopathy Questionnaire score following TMVR (47.8 to 75.7 to 84.0, p <0.0001).
Conclusion(s): We found that treatment of degenerated mitral bioprostheses using TMVR with the third-generation balloon-expandable transcatheter heart valve in high-risk patients resulted in significant improvements in short-term and long-term heart failure symptoms, which translated to robust short- and long-term survival.
Copyright
EMBASE:2014132625
ISSN: 1878-0938
CID: 4987352

Initial Single-Center ST-Segment Elevation Myocardial Infarction Experience in New York Before and During the COVID-19 Pandemic [Meeting Abstract]

Medranda, G A; Brahmbhatt, K; Alawneh, B; Marzo, K P; Schwartz, R K; Green, S J
Background: Following a period of stability, the coronavirus disease 2019 (COVID-19) pandemic appears to be re-intensifying globally. As the pandemic continues to evolve, so does our understanding of its implications on ST-segment elevation myocardial infarction (STEMI). We sought to describe a single center STEMI experience at one of the epicenters of the COVID-19 pandemic.
Method(s): This was a retrospective observational study which included consecutive suspected STEMI patients from March 1 through August 31, 2019, (Cohort 1) compared to the same time period in 2020 (Cohort 2), at a tertiary referral center in Nassau County, New York.
Result(s): Cohort 2 (n=93) saw a similar number of acute myocardial infarction (AMI) team activations compared to cohort 1 (n=90) (Figure 1). Infection control measures and additional investigation were required to clarify the diagnosis in cohort 2, resulting in longer door-to-balloon times (95.9 minutes vs. 74.4 minutes, p=0.0587). We observed similar inpatient length of stay (LOS) (3.6 days vs. 5.0 days, p=0.0901) and mortality (13.2% vs. 9.2%, p=0.5876).
Conclusion(s): Our single-center study, located at one of the epicenters of the pandemic, demonstrated a similar number of AMI team activations, mimicking the seasonal variability seen in 2019, but with longer door-to-balloon times. Despite this, inpatient LOS and mortality remained unchanged. [Formula presented]
Copyright
EMBASE:2014132639
ISSN: 1878-0938
CID: 4987342

The Impact of Aortic Angulation on Contemporary Transcatheter Aortic Valve Replacement Outcomes

Medranda, Giorgio A; Musallam, Anees; Zhang, Cheng; Rappaport, Hank; Gallino, Paige E; Case, Brian C; Satler, Lowell F; Ben-Dor, Itsik; Rogers, Toby; Waksman, Ron
OBJECTIVES:The aim of this study was to investigate whether the degree of aortic angulation (AA) affects outcomes after transcatheter aortic valve replacement (TAVR) using newer-generation transcatheter heart valves (THVs). BACKGROUND:AA ≥48° has been reported to adversely influence accurate THV deployment, procedural success, fluoroscopy time, and paravalvular leak (PVL) in patients undergoing TAVR with early generation self-expanding (SE) THVs. METHODS:A retrospective observational study was conducted among 841 patients across all risk strata who underwent transfemoral TAVR using the balloon-expandable (BE) SAPIEN 3 or the SE CoreValve Evolut PRO from 2015 to 2020. The previously published cutoff of 48° was used to analyze procedural success and in-hospital outcomes according to THV type. Receiver-operating characteristic analysis was performed to investigate the impact of AA on an in-hospital composite outcome (need for >1 THV, more than mild PVL, new permanent pacemaker implantation, stroke, and death). RESULTS:AA ≥48° did not influence outcomes in patients with BE THVs. Additionally, AA ≥48° did not influence procedural success (99.1% vs. 99.1%; p = 0.980), number of THVs used (1.02 vs. 1.04; p = 0.484), rates of more than mild PVL (0.4% vs. 0%; p = 0.486), new permanent pacemaker implantation (11.8% vs. 17.1%; p = 0.178), in-hospital stroke (3.9% vs. 1.8%; p = 0.298), or in-hospital death (0.4% vs. 0.9%; p = 0.980) in patients with SE THVs. Receiver-operating characteristic analysis demonstrated similar outcomes irrespective of AA, with areas under the curve of 0.5525 for SE THVs and 0.5115 for BE THVs. CONCLUSIONS:AA no longer plays a role with new-generation BE or SE THVs in contemporary TAVR practice. AA ≥48° did not affect procedural success or in-hospital outcomes and should no longer be a consideration when determining THV selection.
PMID: 34112456
ISSN: 1876-7605
CID: 5155442