Publications by authors named "Rishi Puri"

285 Publications

Valve-in-valve transcatheter aortic valve implantation versus repeat surgical aortic valve replacement in patients with a failed aortic bioprosthesis.

EuroIntervention 2021 Sep 15. Epub 2021 Sep 15.

Department of Cardiology, Maimonides Medical Center, Brooklyn, NY, USA.

Background: Limited data are available regarding clinical outcomes of valve-in-valve (ViV) transcatheter aortic valve implantation (TAVI) following the United States Food and Drug Administration approval of ViV TAVI in 2015.

Aims: The aim of this study was to evaluate in-hospital, 30-day, and 6-month outcomes of ViV TAVI versus repeat surgical aortic valve replacement (SAVR) in patients with a failed aortic bioprosthetic valve.

Methods: This retrospective cohort study identified patients who underwent ViV TAVI or repeat SAVR utilising the Nationwide Readmission Database from 2016 to 2018. Primary outcomes were all-cause readmission (at 30 days and 6 months) and in-hospital death. Secondary outcomes were in-hospital stroke, pacemaker implantation, 30-day/6-month major adverse cardiac events (MACE), and mortality during readmission. Propensity score-matching (inverse probability of treatment weighting) analyses were implemented.

Results: Out of 6,769 procedures performed, 3,724 (55%) patients underwent ViV TAVI, and 3,045 (45%) underwent repeat SAVR. ViV TAVI was associated with lower in-hospital all-cause mortality (odds ratio [OR] 0.42, 95% confidence interval [CI]: 0.20-0.90, p=0.026) and a higher rate of 30-day (hazard ratio [HR] 1.46, 95% CI: 1.13-1.90, p=0.004) and 6-month all-cause readmission (HR 1.54, 95% CI: 1.14-2.10, p=0.006) compared with repeat SAVR. All secondary outcomes were comparable between the two groups.

Conclusions: ViV TAVI was associated with lower in-hospital mortality but higher 30-day and 6-month all-cause readmission. However, there was no difference in risk of in-hospital stroke, post-procedure pacemaker implantation, MACE, and mortality during 30-day and 6-month readmission compared with repeat SAVR, suggesting that ViV TAVI can be performed safely in carefully selected patients.
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http://dx.doi.org/10.4244/EIJ-D-21-00472DOI Listing
September 2021

Incidence and Outcomes of Pericardial Effusion and Cardiac Tamponade Following Permanent Pacemaker Implantation After Transcatheter Aortic Valve Implantation.

Am J Cardiol 2021 Aug 5. Epub 2021 Aug 5.

Department of Cardiovascular Medicine, Cleveland Clinic - Main Campus, 9500 Euclid Avenue, Desk J2-3, Cleveland, Ohio. Electronic address:

Permanent pacemaker (PPM) implantation is required in 5% to 10% of patients following transcatheter aortic valve implantation (TAVI). However, there are limited data on the impact of PPM implantation on the incidence of pericardial effusion, cardiac tamponade, and outcomes after TAVI. We identified all hospitalizations in patients ≥18 years of age who underwent TAVI in the years 2016 to 2017 in the Nationwide Readmission Database. The endpoints of the study were pericardial effusion, cardiac tamponade, and percutaneous or surgical drainage of the pericardial cavity in patients that required PPM implantation after TAVI. Multivariable logistic regression determined associations of PPM implantation, pericardial effusion, and tamponade with patient outcomes. A total of 54,317 unweighted hospitalizations for TAVI were identified, of which 5,639 (10.4%) required PPM. The risk of pericardial effusion was significantly greater in patients who required PPM (2.4% vs 1.6%, adjusted odds ratio (aOR) 1.39 (1.15 to 1.70), p <0.001)), and risk of cardiac tamponade nearly doubled (1.6% vs 0.8%, p <0.001; aOR: 1.90 (1.48 to 2.40), p <0.001). Female gender was independently associated with increased risk of pericardial effusion and cardiac tamponade whereas history of previous  CABG was associated with decreased risk of both. Pericardial complications following PPM implantation were associated with increased in-hospital mortality, length of stay (LOS), hospital costs, and risk of 30-day readmission following TAVI (p <0.01 for all comparisons). In conclusion, although common, PPM implantation post-TAVI carries increased risks of pericardial effusion and associated cardiac tamponade. Patients developing these pericardial complications are at particularly high-risk for in-hospital mortality, greater LOS, and 30-day readmission.
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http://dx.doi.org/10.1016/j.amjcard.2021.07.027DOI Listing
August 2021

Prognostic implications and outcomes of cardiac arrest among contemporary patients with STEMI treated with PCI.

Resusc Plus 2021 Sep 15;7:100149. Epub 2021 Jul 15.

Heart and Vascular Institute, Cleveland Clinic Foundation, Cleveland, OH United States.

Background: Cardiac arrest (CA) complicating ST-elevation myocardial infarction (STEMI) is associated with a disproportionately higher risk of mortality. We described the contemporary presentation, management, and outcomes of CA patients in the era of primary percutaneous coronary intervention (PCI).

Methods: We reviewed 1,272 consecutive STEMI patients who underwent PCI between 1/1/2011-12/31/2016 and compared characteristics and outcomes between non-CA (N = 1,124) and CA patients (N = 148), defined per NCDR definitions as pulseless arrest requiring cardiopulmonary resuscitation and/or defibrillation within 24-hr of PCI.

Results: Male gender, cerebrovascular disease, chronic kidney disease, in-hospital STEMI, left main or left anterior descending culprit vessel, and initial TIMI 0 or 1 flow were independent predictors for CA. CA patients had longer door-to-balloon-time (106 [83,139] vs. 97 [74,121] minutes, p = 0.003) and greater incidence of cardiogenic shock (48.0% vs. 5.9%, p < 0.001), major bleeding (25.0% vs. 9.4%, p < 0.001), and 30-day mortality (16.2% vs. 4.1%, p < 0.001). Risk score for 30-day mortality based on presenting characteristics provided excellent prognostic accuracy (area under the curve = 0.902). However, over long-term follow-up of 4.5 ± 2.4 years among hospital survivors, CA did not portend any additional mortality risk (HR: 1.01, 95% CI: 0.56-1.82, p = 0.97).

Conclusions: In a contemporary cohort of STEMI patients undergoing primary PCI, CA occurs in >10% of patients and is an important mechanism of mortality in patients with in-hospital STEMI. While CA is associated with adverse outcomes, it carries no additional risk of long-term mortality among survivors highlighting the need for strategies to improve the in-hospital care of STEMI patients with CA.
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http://dx.doi.org/10.1016/j.resplu.2021.100149DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8319445PMC
September 2021

C-reactive protein levels and plaque regression with evolocumab: Insights from GLAGOV.

Am J Prev Cardiol 2020 Sep 6;3:100091. Epub 2020 Oct 6.

Monash Cardiovascular Research Centre, Victorian Heart Institute, Monash University, Melbourne, Australia.

Objective: On-treatment levels of high sensitivity C-reactive protein (hsCRP) in statin-treated patients predict plaque progression and the prospective risk of atherosclerotic cardiovascular events. Proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors produce additional LDL-C lowering, reduce plaque burden and improve cardiovascular outcomes in statin-treated patients. It is unknown whether residual systemic inflammation attenuates their favorable effects on plaque burden.

Methods: GLAGOV compared the effects of treatment for 78 weeks with evolocumab or placebo on progression of coronary atherosclerosis in statin-treated patients with coronary artery disease.Clinical demographics, biochemistry and changes in both the burden (percentage atheroma volume (PAV), total atheroma volume (TAV), n ​= ​413) and composition (n ​= ​162) of coronary plaque were evaluated in evolocumab-treated patients according to baseline hsCRP strata (<1, 1-3, >3 ​mg/L).

Results: The study cohort comprised 413 evolocumab-treated patients (32% low [<1 ​mg/L], 41% intermediate [1-3 ​mg/L] and 27% high [>3 ​mg/L] baseline hsCRP levels). Patients in the highest hsCRP stratum were more likely to be female and had a higher prevalence of diabetes, hypertension, and the metabolic syndrome. LDL-C levels were similar across the groups, however participants with higher hsCRP levels had higher triglyceride and lower HDL-C levels at baseline. At follow-up, the change in PAV from baseline (-0.87% [low] vs. -0.84% [intermediate] vs. -1.22% [high], p ​= ​0.46) and the proportion of patients experiencing any degree of regression (65.9% vs. 63.5% vs. 63.1%, p ​= ​0.88) was similar across hsCRP strata and when evaluated by levels of achieved LDL-C. There were no serial differences in plaque composition by hsCRP strata.

Conclusion: The ability of evolocumab to induce regression in statin-treated patients is not attenuated by the presence of enhanced systemic inflammation. This underscores the potential benefits of intensive lipid lowering, even in the presence of heightened inflammatory states.
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http://dx.doi.org/10.1016/j.ajpc.2020.100091DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8315612PMC
September 2020

Remnant cholesterol predicts cardiovascular disease beyond LDL and ApoB: a primary prevention study.

Eur Heart J 2021 Jul 19. Epub 2021 Jul 19.

Johns Hopkins Ciccarone Center for the Prevention of Cardiovascular Disease, Baltimore, MD, USA.

Aims: Emerging evidence suggests that remnant cholesterol (RC) promotes atherosclerotic cardiovascular disease (ASCVD). We aimed to estimate RC-related risk beyond low-density lipoprotein cholesterol (LDL-C) and apolipoprotein B (apoB) in patients without known ASCVD.

Methods And Results: We pooled data from 17 532 ASCVD-free individuals from the Atherosclerosis Risk in Communities study (n = 9748), the Multi-Ethnic Study of Atherosclerosis (n = 3049), and the Coronary Artery Risk Development in Young Adults (n = 4735). RC was calculated as non-high-density lipoprotein cholesterol (non-HDL-C) minus calculated LDL-C. Adjusted Cox models were used to estimate the risk for incident ASCVD associated with log RC levels. We also performed discordance analyses examining relative ASCVD risk in RC vs. LDL-C discordant/concordant groups using difference in percentile units (>10 units) and clinically relevant LDL-C targets. The mean age of participants was 52.3 ± 17.9 years, 56.7% were women and 34% black. There were 2143 ASCVD events over the median follow-up of 18.7 years. After multivariable adjustment including LDL-C and apoB, log RC was associated with higher ASCVD risk [hazard ratio (HR) 1.65, 95% confidence interval (CI) 1.45-1.89]. Moreover, the discordant high RC/low LDL-C group, but not the low RC/high LDL-C group, was associated with increased ASCVD risk compared to the concordant group (HR 1.21, 95% CI 1.08-1.35). Similar results were shown when examining discordance across clinical cutpoints.

Conclusions: In ASCVD-free individuals, elevated RC levels were associated with ASCVD independent of traditional risk factors, LDL-C, and apoB levels. The mechanisms of RC association with ASCVD, surprisingly beyond apoB, and the potential value of targeted RC-lowering in primary prevention need to be further investigated.
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http://dx.doi.org/10.1093/eurheartj/ehab432DOI Listing
July 2021

Roles of Cardiac Computed Tomography in Guiding Transcatheter Tricuspid Valve Interventions.

Curr Cardiol Rep 2021 07 16;23(9):114. Epub 2021 Jul 16.

Department of Cardiovascular Medicine, Heart, Vascular, and Thoracic Institute, Cleveland Clinic, Cleveland, OH, USA.

Purpose Of Review: The field of transcatheter tricuspid valve interventions (TTVI) is rapidly evolving to meet a well-defined but unmet clinical need. Severe tricuspid regurgitation is common and is associated with significant morbidity and mortality. Surgical options are limited and of high risk. The success of TTVI depends on careful procedural planning, and cardiac computed tomography (CCT) plays an emerging key role.

Recent Findings: TTVI technologies have various targets, including the leaflets, annulus, and venae cavae, along with valve replacement. Based on the planned procedure, CCT allows for device sizing, careful assessment of the access route, and comprehensive analysis of relevant adjacent anatomic structures to enhance procedural safety. It can also evaluate right-sided heart function, and its data can be for fusion imaging and 3D printing. Procedural planning is key to TTVI's success and is highly dependent on high-quality CCT data. This review details the comprehensive roles of CCT, specifics of the dedicated TTVI protocol, and its limitations.
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http://dx.doi.org/10.1007/s11886-021-01547-7DOI Listing
July 2021

Transcatheter Aortic Valve Implantation in Patients With Inflammatory Bowel Disease.

Am J Cardiol 2021 09 6;154:133-135. Epub 2021 Jul 6.

Department of Cardiovascular Medicine, Heart and Vascular Institute, Cleveland Clinic, Cleveland, Ohio. Electronic address:

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http://dx.doi.org/10.1016/j.amjcard.2021.05.030DOI Listing
September 2021

Incidence, treatment, and outcomes of acute myocardial infarction following transcatheter or surgical aortic valve replacement.

Catheter Cardiovasc Interv 2021 Jul 8. Epub 2021 Jul 8.

Department of Cardiovascular Medicine, Heart, Vascular and Thoracic Institute, Cleveland Clinic, Cleveland, Ohio, USA.

Objectives: This study aimed to evaluate the incidence, treatment, and outcomes of acute myocardial infarction (AMI) following transcatheter or surgical aortic valve replacement (TAVR or SAVR).

Background: Coronary artery disease is common in patients who undergo aortic valve replacement. However, little is known about differences in clinical features of post-TAVR or post-SAVR AMI.

Methods: We retrospectively identified post-TAVR or post-SAVR (including isolated and complex SAVR) patients admitted with AMI using the Nationwide Readmissions Database 2012-2017. Incidence, invasive strategy (coronary angiography or revascularization), and in-hospital outcomes were compared between post-TAVR and post-SAVR AMIs.

Results: The incidence of 180-day AMI was higher post-TAVR than post-SAVR (1.59% vs. 0.72%; p < 0.001). Post-TAVR AMI patients (n = 1315), compared with post-SAVR AMI patients (n = 1344), were older, had more comorbidities and more frequent non-ST-elevation AMI (NSTEMI: 86.6% vs. 78.0%; p < 0.001). After propensity-score matching, there was no significant difference in in-hospital mortality between post-TAVR and post-SAVR AMIs (14.7% vs. 16.1%; p = 0.531), but the mortality was high in both groups, particularly in ST-elevation AMI (STEMI: 38.8% vs. 29.2%; p = 0.153). Invasive strategy was used less frequently for post-TAVR AMI than post-SAVR AMI (25.6% vs. 38.3%; p < 0.001). Invasive strategy was associated with lower mortality in both post-TAVR (adjusted odds ratio = 0.40; 95% confidence interval = [0.24-0.66]) and post-SAVR groups (0.60 [0.41-0.88]).

Conclusions: AMI, albeit uncommon, was more frequent post-TAVR than post-SAVR. Patients commonly presented with NSTEMI, but the mortality of STEMI was markedly high. Further studies are needed to understand why a substantial percentage of patients do not receive invasive coronary treatment, particularly after TAVR, despite seemingly better outcomes with invasive strategy.
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http://dx.doi.org/10.1002/ccd.29860DOI Listing
July 2021

Quality Assessment of Published Systematic Reviews in High Impact Cardiology Journals: Revisiting the Evidence Pyramid.

Front Cardiovasc Med 2021 9;8:671569. Epub 2021 Jun 9.

Department of Cardiovascular Medicine, Heart, Vascular & Thoracic Institute, Cleveland Clinic Foundation, Cleveland, OH, United States.

Systematic reviews are increasingly used as sources of evidence in clinical cardiology guidelines. In the present study, we aimed to assess the quality of published systematic reviews in high impact cardiology journals. We searched PubMed for systematic reviews published between 2010 and 2019 in five general cardiology journals with the highest impact factor (according to Clarivate Analytics 2019). We extracted data on eligibility criteria, methodological characteristics, bias assessments, and sources of funding. Further, we assessed the quality of retrieved reviews using the AMSTAR tool. A total of 352 systematic reviews were assessed. The AMSTAR quality score was low or critically low in 71% (95% CI: 65.7-75.4) of the assessed reviews. Sixty-four reviews (18.2%, 95% CI: 14.5-22.6) registered/published their protocol. Only 221 reviews (62.8%, 95% CI: 57.6-67.7) reported adherence to the EQUATOR checklists, 208 reviews (58.4%, 95% CI: 53.9-64.1) assessed the risk of bias in the included studies, and 177 reviews (52.3%, 95% CI: 45.1-55.5) assessed the risk of publication bias in their primary outcome analysis. The primary outcome was statistically significant in 274 (79.6%, 95% CI: 75.1-83.6) and had statistical heterogeneity in 167 (48.5%, 95% CI: 43.3-53.8) reviews. The use and sources of external funding was not disclosed in 87 reviews (24.7%, 95% CI: 20.5-29.5). Data analysis showed that the existence of publication bias was significantly associated with statistical heterogeneity of the primary outcome and that complex design, larger sample size, and higher AMSTAR quality score were associated with higher citation metrics. Our analysis uncovered widespread gaps in conducting and reporting systematic reviews in cardiology. These findings highlight the importance of rigorous editorial and peer review policies in systematic review publishing, as well as education of the investigators and clinicians on the synthesis and interpretation of evidence.
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http://dx.doi.org/10.3389/fcvm.2021.671569DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8220077PMC
June 2021

Predicting Infective Endocarditis After Transcatheter Aortic Valve Implantation Via a Risk Model.

Am J Cardiol 2021 07 9;150:131-132. Epub 2021 May 9.

Dept. of Cardiovascular Medicine, Heart and Vascular Institute, Cleveland Clinic, Cleveland, Ohio. Electronic address:

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http://dx.doi.org/10.1016/j.amjcard.2021.04.007DOI Listing
July 2021

Outcomes of transcatheter tricuspid valve intervention by right ventricular function: a multicentre propensity-matched analysis.

EuroIntervention 2021 Jul 20;17(4):e343-e352. Epub 2021 Jul 20.

Department of Internal Medicine/Cardiology, Heart Center Leipzig at University of Leipzig and Leipzig Heart Institute, Leipzig, Germany.

Background: Tricuspid regurgitation (TR) has a poor prognosis and limited treatment options and is frequently accompanied by right ventricular (RV) dysfunction. Transcatheter tricuspid valve interventions (TTVI) to reduce TR have been shown to be safe and feasible with encouraging early results. Patient selection for TTVI remains challenging, with the role of right ventricular (RV) function being unknown.

Aims: The aims of this study were 1) to investigate survival in a TTVI-treated patient population and a conservatively treated TR population, and 2) to evaluate the outcome of TTVI as compared to conservative treatment stratified according to the degree of RV function.

Methods: We studied 684 patients from the multicentre TriValve cohort (TTVI cohort) and compared them to 914 conservatively treated patients from two tertiary care centres. Propensity matching identified 213 pairs of patients with severe TR. As we observed a non-linear relationship of RV function and TTVI outcome, we stratified patients according to tricuspid annular plane systolic excursion (TAPSE) to preserved (TAPSE >17 mm), mid-range (TAPSE 13-17 mm) and reduced (TAPSE <13 mm) RV function. The primary outcome was one-year all-cause mortality.

Results: TTVI was associated with a survival benefit in patients with severe TR when compared to matched controls (one-year mortality rate: 13.1% vs 25.8%; p=0.031). Of the three RV subgroups, only in patients with mid-range RV function was TTVI associated with an improved survival (p log-rank 0.004). In these patients, procedural success was associated with a reduced hazard ratio for all-cause mortality (HR 0.22; 95% CI: 0.09, 0.57).

Conclusions: TTVI is associated with reduced mortality compared to conservative therapy and might exert its highest treatment effect in patients with mid-range reduced RV function.
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http://dx.doi.org/10.4244/EIJ-D-21-00191DOI Listing
July 2021

Transcatheter Closure of Patent Foramen Ovale: Not Always an "Open or Shut" Case.

Circulation 2021 Apr 19;143(16):1539-1541. Epub 2021 Apr 19.

Division of Cardiology, Duke University Health System, Durham, NC (R.A.K.).

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http://dx.doi.org/10.1161/CIRCULATIONAHA.120.050961DOI Listing
April 2021

Severe Atrial Functional Mitral Regurgitation: Clinical and Echocardiographic Characteristics, Management and Outcomes.

JACC Cardiovasc Imaging 2021 04;14(4):797-808

Department of Cardiovascular Medicine, Heart, Vascular, and Thoracic Institute, Cleveland Clinic, Cleveland, Ohio, USA. Electronic address:

Objectives: This study was designed to compare the clinical and echocardiographic characteristics, management, and outcomes of severe atrial functional mitral regurgitation (AFMR) to primary mitral regurgitation (PMR).

Background: AFMR remains poorly defined clinically.

Methods: Consecutive patients who underwent transesophageal echocardiography at our institution between 2011 and 2018 for severe mitral regurgitation with preserved left ventricular function were screened. We excluded patients with endocarditis, any form of cardiomyopathy, or prior mitral intervention. The absence of leaflet pathology defined AFMR. Outcomes included death and heart failure hospitalizations.

Results: A total of 283 patients were included (AFMR = 14%, PMR = 86%). Compared to PMR, patients with AFMR had more comorbidities, including hypertension (94.9% vs. 76.2%; p = 0.015), diabetes mellitus (46.2% vs. 18.4%; p < 0.001), long-standing atrial fibrillation (28.2% vs. 13.1%; p = 0.015), prior nonmitral cardiac surgery (25.6% vs. 9.8%; p = 0.004), and pacemaker placement (33.3% vs. 13.5%; p = 0.002). They also had higher average E/e' (median [interquartile range]:16.04 [13.1 to 22.46] vs. 14.1 [10.89 to 19]; p = 0.036) and worse longitudinal left atrial strain peak positive value (16.86 ± 12.15% vs. 23.67 ± 14.09%; p = 0.002) compared to PMR. During follow-up (median: 22 months), patients with AFMR had worse survival (log-rank p = 0.009) and more heart failure hospitalizations (log-rank p = 0.002). They were also less likely to undergo mitral valve intervention (59.0% vs. 83.6%; p = 0.001), although surgery was associated with improved survival (log-rank p = 0.021). On multivariable regression analysis, AFMR was independently associated with mortality [adjusted odds ratio: 2.61, 95% confidence interval: 1.17 to 5.83; p = 0.02].

Conclusions: AFMR constitutes an under-recognized high-risk group, with significant comorbidities, limited therapeutic options, and poor outcomes.
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http://dx.doi.org/10.1016/j.jcmg.2021.02.008DOI Listing
April 2021

Intravascular Ultrasound Insights Into Perforation After Coronary Atherectomy.

J Invasive Cardiol 2021 05 15;33(5):E393-E395. Epub 2021 Mar 15.

Cleveland Clinic, 9500 Euclid Avenue, Desk J2-3, Cleveland, OH 44195. Email:

Background: In recent years, there has been strong evidence to support the regular use of intravascular ultrasound (IVUS) imaging to optimize the results of percutaneous coronary intervention (PCI). This holds particularly true in more complex cases, such as calcific lesions, whereby angiographic evaluation is often insufficient to determine whether a vessel has been adequately prepared or to perform reference vessel sizing. Severe calcific lesions are often treated with coronary atherectomy to debulk the calcific plaque and allow for adequate predilation of the lesion before stenting. As we have become more familiar with the use of IVUS for stent optimization, we postulated whether certain vessel characteristics seen on IVUS could help to anticipate procedural complications. We provide a descriptive analysis, including IVUS findings, of 10 patients who underwent PCI complicated by coronary perforation following coronary atherectomy. Our findings generate the hypothesis that independent mobility of calcium identified on IVUS in patients treated with coronary atherectomy may be a warning sign for impending perforation. Further studies are needed to validate this hypothesis and to potentially identify other IVUS findings that could be associated with increased risk of procedural complications.
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May 2021

Implications of Atrial Fibrillation on the Mechanisms of Mitral Regurgitation and Response to MitraClip in the COAPT Trial.

Circ Cardiovasc Interv 2021 04 15;14(4):e010300. Epub 2021 Mar 15.

Baylor Scott and White Health, Plano, TX (M.J.M.).

Background: Atrial fibrillation (AF), mitral regurgitation (MR), and left ventricular (LV) ejection fraction have a complex interplay. We evaluated the role of AF in patients with heart failure and moderate-to-severe or severe secondary MR enrolled in the randomized COAPT trial (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation) and its impact on mechanisms and outcomes with the MitraClip.

Methods: Patients in the COAPT trial were stratified by the presence (n=327) or absence (n=287) of a history of AF and by assignment to treatment group. Clinical, echocardiographic, and outcome measures were assessed. The primary outcome was the composite rate of death or heart failure hospitalization at 24 months.

Results: Patients with history of AF were older and more often male. They had a higher LV ejection fraction, larger left atrial volumes and mitral valve orifice areas, smaller LV volumes, and similar MR severity. Patients with AF compared with those without a history of AF had a higher unadjusted (hazard ratio [HR], 1.32 [95% CI, 1.06–1.64], P=0.01) and adjusted (HR, 1.30 [1.03–1.64], P=0.03) 2-year rate of the primary outcome. Treatment with the MitraClip compared with guideline-directed medical therapy alone reduced death or heart failure hospitalization in both those with (HR, 0.61 [0.46–0.82]) and without (HR, 0.46 [0.33–0.66]) a history of AF (Pint=0.18). Treatment with the MitraClip was associated with a lower risk of stroke in patients with a history of AF (HR, 0.18 [0.04–0.86]) but not in those without a history of AF (HR, 1.64 [0.58–4.62]; Pint=0.02).

Conclusions: In the COAPT trial, patients with a history of AF had larger left atrial and mitral valve orifice areas with higher LV ejection fraction and smaller LV volumes, suggesting an atrial mechanism contribution to functional MR. Despite the worse prognosis of heart failure patients with a history of AF, MR reduction with the MitraClip still afforded substantial clinical benefits. Treatment with MitraClip was associated with a lower risk of stroke in patients with a history of AF.

Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01626079.
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http://dx.doi.org/10.1161/CIRCINTERVENTIONS.120.010300DOI Listing
April 2021

Assessing the impact of PCSK9 inhibition on coronary plaque phenotype with optical coherence tomography: rationale and design of the randomized, placebo-controlled HUYGENS study.

Cardiovasc Diagn Ther 2021 Feb;11(1):120-129

Monash Cardiovascular Research Centre, Clayton, Australia.

Background: Technological advances in arterial wall imaging permit the opportunity to visualize coronary atherosclerotic plaque with sufficient resolution to characterize both its burden and compositional phenotype. These modalities have been used extensively in clinical trials to evaluate the impact of lipid lowering therapies on serial changes in disease burden. While the findings have unequivocally established that these interventions have the capacity to either slow disease progression or promote plaque regression, depending on the degree of lipid lowering achieved, their impact on plaque phenotype is less certain. More recently optical coherence tomography (OCT) has been employed with a number of studies demonstrating favorable effects on both fibrous cap thickness (FCT) and the size of lipid pools within plaque in response to statin treatment.

Methods: The phase 3, multi-center, double-blind HUYGENS study will assess the impact of incremental lipid lowering with the proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitor, evolocumab, on plaque features using serial OCT imaging, in statin-treated patients following an acute coronary syndrome (ACS). Subjects with non-ST-elevation ACS (n=150) will be randomized 1:1 into two groups to receive monthly injections of evolocumab 420 mg or placebo.

Results: The primary endpoint is the effect of evolocumab on coronary atherosclerotic plaques will be assessed by OCT at baseline and at week 50.

Conclusions: The HUYGENS study will determine whether intensified lipid lowering therapy with evolocumab in addition to maximally tolerated statin therapy will have incremental benefits on high-risk features of coronary artery plaques.

Trial Registration: This study was registered on Clinicaltrials.gov (NCT03570697).
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http://dx.doi.org/10.21037/cdt-20-684DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7944215PMC
February 2021

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

Can J Cardiol 2021 Jul 19;37(7):1094-1102. Epub 2021 Feb 19.

Cardiology Department, Department of Cardiology, Hospital Universitario Puerta de Hierro, Madrid, Spain.

Background: Scarce data exist on patients with previous left valve surgery (PLVS) undergoing transcatheter tricuspid valve intervention (TTVI). This study sought to investigate the procedural and early outcomes in patients with PLVS undergoing TTVI.

Methods: This was a subanalysis 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 female (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 rehospitalisation (PLVS 21.1%, no-PLVS 26.5%; P = 0.60) and all-cause mortality (PLVS 9.8%, no-PLVS 6.7%; P = 0.58). At last follow-up (median 6 [interquartile range 1-12] months after the procedure), most patients (81.8%) in the PLVS group were in NYHA functional 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). A poorer right ventricular function and previous heart failure hospitalization determined increased risks of procedural failure and poorer outcomes at follow-up, respectively.

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 rehospitalisation 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 to improve clinical outcomes.
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http://dx.doi.org/10.1016/j.cjca.2021.02.010DOI Listing
July 2021

Aspirin Versus Dual Antiplatelet Therapy in Patients Undergoing Trans-Catheter Aortic Valve Implantation, Updated Meta-Analysis.

Cardiovasc Drugs Ther 2021 Feb 15. Epub 2021 Feb 15.

Department of Cardiothoracic Services, Freeman Hospital, Newcastle-upon-Tyne, NE7 7DN, UK.

Background: The Antiplatelet Therapy for Patients Undergoing Transcatheter Aortic-Valve Implantation (POPular TAVI) trial reported comparable composite endpoints of ischemic events using aspirin compared to dual antiplatelet therapy (DAPT). However, this trial was not powered to detect individual differences in ischemic events. We sought to conduct a meta-analysis to compare aspirin to DAPT on ischemic and bleeding events following TAVI.

Methods: The MEDLINE database was searched from inception until September 2020 and only randomized clinical trials of patients receiving antiplatelet therapy following TAVI were included. The treatment effect was reported as rate ratios (RRs) with 95% confidence intervals.

Results: Four randomized clinical trials of 1086 TAVI patients were included. There was a 51% reduction in major or life-threatening bleeding with aspirin compared with DAPT [RR 0.49, (95%CI 0.31 to 0.78)]. Aspirin was not associated with an increased risk of death [RR 1.01, (95%CI 0.62 to 1.65)], cardiovascular death [RR 1.15, (95%CI 0.56 to 2.36)], ischemic stroke [RR 0.93, (95%CI 0.51 to 1.70)], or MI [RR 0.53, (95%CI 0.18 to 1.57)].

Conclusions: This meta-analysis supports the use of aspirin as the optimal antiplatelet strategy following TAVI procedures in reducing bleeding without an increase in ischemic events compared with dual antiplatelet therapy.
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http://dx.doi.org/10.1007/s10557-021-07146-6DOI Listing
February 2021

Outcomes of transcatheter aortic valve replacement in patients with cognitive dysfunction.

J Am Geriatr Soc 2021 May 11;69(5):1363-1369. Epub 2021 Feb 11.

Section of Cardiovascular Research, Heart, Vascular and Thoracic Department, Cleveland Clinic Akron General, Akron, Ohio, USA.

Importance: The impact of pre-existing cognitive dysfunction on outcomes after transcatheter aortic valve replacement (TAVR) remains unclear.

Objective: To study the association between dementia and post-TAVR outcomes.

Design: Cohort study with propensity-score matching was conducted using the Nationwide Inpatient Sample.

Exposures: History of dementia at the time of undergoing TAVR.

Main Outcomes: All-cause in-hospital mortality, stroke, bleeding requiring transfusion, acute kidney injury, post-procedural vascular complications, post-procedural pacemaker implantation, length of stay, in-hospital delirium, and discharge disposition in patients with and without dementia undergoing TAVR.

Results: Of 57,805 patients undergoing TAVR, 2910 (5.0%) had a diagnosis of dementia. Propensity-score matching yielded 2895 matched pairs of patients. TAVR was associated with an increased risk of bleeding requiring transfusion (14.7% vs 8.6%, odd ratio (OR) 1.82 [95% confidence interval (CI) 1.26-2.63]; p < 0.01), discharge to a rehabilitation facility (45.8% vs 31.6%, OR 2.27 [95% CI 1.67-3.08]; p < 0.001), in-hospital delirium (7.4% vs 3.6%, OR 2.13 [95% CI 1.26-3.61]; p < 0.01), increased length of stay (6.75 ± 0.07 days vs 6.11 ± 0.06 days, slope = 1.11 [95% CI 1.03-1.19]; p < 0.01), but comparable in-hospital mortality (2.1% vs 2.6%, OR 1.26 [95% CI 0.57-2.79]; p = 0.57] in patients with dementia compared with patients without dementia.

Conclusions And Relevance: This study found that patients with dementia undergoing TAVR had a longer hospital stay as well as higher rates of discharge to a rehabilitation facility and in-hospital delirium, which may indicate debility and functional decline during hospitalization; however, in-hospital mortality and other outcomes were comparable between the two groups. TAVR candidates should be subjected to a comprehensive geriatric and cognitive assessment to help risk-stratify them for potential post-procedural functional decline. Prospective studies aimed at standardizing cognitive scoring and evaluating the post-procedural quality of life are needed.
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http://dx.doi.org/10.1111/jgs.17048DOI Listing
May 2021

Coronary artery aneurysms: outcomes following medical, percutaneous interventional and surgical management.

Open Heart 2021 02;8(1)

Heart and Vascular Institute, Cleveland Clinic, Cleveland, Ohio, USA

Background: Coronary artery aneurysms (CAAs) are increasingly diagnosed on coronary angiography; however, controversies persist regarding their optimal management. In the present study, we analysed the long-term outcomes of patients with CAAs following three different management strategies.

Methods: We performed a retrospective review of patient records with documented CAA diagnosis between 2000 and 2005. Patients were divided into three groups: medical management versus percutaneous coronary intervention (PCI) versus coronary artery bypass grafting (CABG). We analysed the rate of major cardiovascular and cerebrovascular events (MACCEs) over a period of 10 years.

Results: We identified 458 patients with CAAs (mean age 78±10.5 years, 74.5% men) who received medical therapy (N=230) or underwent PCI (N=52) or CABG (N=176). The incidence of CAAs was 0.7% of the total catheterisation reports. The left anterior descending was the most common coronary artery involved (38%). The median follow-up time was 62 months. The total number of MACCE during follow-up was 155 (33.8%); 91 (39.6%) in the medical management group vs 46 (26.1%) in the CABG group vs 18 (34.6%) in the PCI group (p=0.02). Kaplan-Meier survival analysis showed that CABG was associated with better MACCE-free survival (p log-rank=0.03) than medical management. These results were confirmed on univariate Cox regression, but not multivariate regression (OR 0.773 (0.526 to 1.136); p=0.19). Both Kaplan-Meier survival and regression analyses showed that dual antiplatelet therapy (DAPT) and anticoagulation were not associated with significant improvement in MACCE rates.

Conclusion: Our analysis showed similar long-term MACCE risks in patients with CAA undergoing medical, percutaneous and surgical management. Further, DAPT and anticoagulation were not associated with significant benefits in terms of MACCE rates. These results should be interpreted with caution considering the small size and potential for selection bias and should be confirmed in large, randomised trials.
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http://dx.doi.org/10.1136/openhrt-2020-001440DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7878141PMC
February 2021

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

Circ Cardiovasc Interv 2021 02 5;14(2):e009685. Epub 2021 Feb 5.

Department of Cardiology, Hospital Universitario Puerta de Hierro, Madrid, Spain (R.E.-L., V.M.).

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

Effect of High-Density Lipoprotein Cholesterol Levels on Overall Survival and Major Adverse Cardiovascular and Cerebrovascular Events.

Am J Cardiol 2021 05 31;146:8-14. Epub 2021 Jan 31.

Robert and Suzanne Tomsich Department of Cardiovascular Medicine, Heart, Vascular and Thoracic Institute, Cleveland Clinic, Cleveland, Ohio. Electronic address:

Several studies designed to augment high density lipoprotein (HDL) levels have so far been unsuccessful in reducing rates of major adverse cardiovascular and cerebrovascular events (MACCE). In this study, we report the effect of HDL-C levels on overall survival outcomes and rates of MACCE following percutaneous coronary intervention (PCI). We reviewed patients who underwent PCI at the Cleveland Clinic from 2005 to 2017 and followed them through the end of 2018. Restricted cubic splines incorporated into Cox proportional hazard regression models were used to assess the outcomes. The HDL-C level associated with the lowest mortality was used as a reference value.15,633 patients underwent PCI during the study period, of which 70% were male, 81% were white, and 73% were on statins. The mean age at the time of procedure was 65.8 ± 11.8 years. After adjusting for demographics, co-morbidities, lipid profile, statin use, and date of procedure, our model demonstrated a U-shaped association between HDL-C and overall mortality, with HDL-C levels of 30-50 mg/dl associated with the most favorable outcomes, and HDL-C levels < 30 mg/dl or > 50 mg/dl associated with worse outcomes. A sensitivity analysis in men yielded a similar U-shaped association. In conclusion, our study shows that both low and high levels of HDL-C are associated with worse overall survival, with no effect on rates of MACCE in PCI patients. Further studies are required to understand the mechanism of this association between elevated HDL-C levels with increased overall mortality in patients with atherosclerotic cardiovascular disease (ASCVD).
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http://dx.doi.org/10.1016/j.amjcard.2021.01.014DOI Listing
May 2021

Incidence, Predictors, and Implications of Permanent Pacemaker Requirement After Transcatheter Aortic Valve Replacement.

JACC Cardiovasc Interv 2021 01;14(2):115-134

Heart and Vascular Institute, Cleveland Clinic Foundation, Cleveland, Ohio, USA. Electronic address:

Transcatheter aortic valve replacement (TAVR) is a safe and feasible alternative to surgery in patients with symptomatic severe aortic stenosis regardless of the surgical risk. Conduction abnormalities requiring permanent pacemaker (PPM) implantation remain a common finding after TAVR due to the close proximity of the atrioventricular conduction system to the aortic root. High-grade atrioventricular block and new onset left bundle branch block (LBBB) are the most commonly reported conduction abnormalities after TAVR. The overall rate of PPM implantation after TAVR varies and is related to pre-procedural and intraprocedural factors. The available literature regarding the impact of conduction abnormalities and PPM requirement on morbidity and mortality is still conflicting. Pre-procedural conduction abnormalities such as right bundle branch block and LBBB have been linked with increased PPM implantation and mortality after TAVR. When screening patients for TAVR, heart teams should be aware of various anatomical and pathophysiological conditions that make patients more susceptible to increased risk of conduction abnormalities and PPM requirement after the procedure. This is particularly important as TAVR has been recently approved for patients with low surgical risk. The purpose of this review is to discuss the incidence, predictors, impact, and management of the various conduction abnormalities requiring PPM implantation in patients undergoing TAVR.
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http://dx.doi.org/10.1016/j.jcin.2020.09.063DOI Listing
January 2021

Systematic Approach to High Implantation of SAPIEN-3 Valve Achieves a Lower Rate of Conduction Abnormalities Including Pacemaker Implantation.

Circ Cardiovasc Interv 2021 01 12;14(1):e009407. Epub 2021 Jan 12.

Heart and Vascular Institute, Cleveland Clinic Foundation, OH.

Background: The conventional method of implanting balloon-expandable SAPIEN-3 (S3) valve results in a final 70:30 or 80:20 ratio of the valve in the aorta:left ventricular outflow tract with published rates of permanent pacemaker around 10%. We sought to evaluate whether higher implantation of S3 reduces conduction abnormalities including the need for permanent pacemaker.

Methods: We included consecutive patients who underwent transfemoral transcatheter aortic valve replacement using S3 between April 2015 and December 2018 and compared outcomes with typical valve deployment strategy to our more contemporary high deployment technique (HDT). We excluded patients with nontransfemoral access or valve-in-valve.

Results: Among 1028 patients, HDT was performed in 406 patients (39.5%). Mean implantation depth under the noncoronary cusp was significantly smaller with HDT compared with conventional technique (1.5±1.6 versus 3.2±1.9 mm; <0.001). Successful implantation was achieved in 100% of the patients in both groups with no cases of conversion to open heart surgery, second valve implantation within the first transcatheter aortic valve replacement, or coronary occlusion during transcatheter aortic valve replacement. One patient (0.2%) had valve embolization with HDT (=0.216). Thirty-day permanent pacemaker rates were lower with HDT (5.5% versus 13.1%; <0.001), as were rates of complete heart block (3.5% versus 11.2%; <0.001) and new-onset left bundle branch block (5.3% versus 12.2%; <0.001). There were no differences in mild (16.5% versus 15.9%; =0.804), or moderate-to-severe aortic regurgitation (1% versus 2.7%; =0.081) at 1 year. HDT was associated with slightly higher 1-year mean gradients (13.1±6.2 versus 11.8±4.9 mm Hg; =0.042) and peak gradients (25±11.9 versus 22.5±9 mm Hg; =0.026). However, Doppler velocity index was similar (0.47±0.15 versus 0.48±0.13; =0.772).

Conclusions: Our novel technique for balloon-expandable S3 valve positioning consistently achieves higher implantation resulting in substantial reduction in conduction abnormalities and permanent pacemaker requirement after transcatheter aortic valve replacement without compromising procedural safety or valve hemodynamics. Operators should consider this as an important technique to improve patient outcomes.
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http://dx.doi.org/10.1161/CIRCINTERVENTIONS.120.009407DOI Listing
January 2021

Adverse Events Related to Excimer Laser Coronary Atherectomy: Analysis of the FDA MAUDE Database.

Cardiovasc Revasc Med 2021 Jun 26;27:88-89. Epub 2020 Dec 26.

Department of Cardiovascular Medicine, Heart, Vascular and Thoracic Institute, Cleveland Clinic, Cleveland, OH, United States of America. Electronic address:

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http://dx.doi.org/10.1016/j.carrev.2020.12.024DOI Listing
June 2021

Corrigendum to: Intraventricular Conduction Disturbances After Transcatheter Aortic Valve Implantation.

Interv Cardiol 2020 Apr 24;15:e17. Epub 2020 Nov 24.

Department of Cardiac Surgery, University Hospital Zurich Zurich, Switzerland.

[This corrects the article DOI: 10.15420/icr.2020.07.].
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http://dx.doi.org/10.15420/icr.2020.33DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7726849PMC
April 2020

Benefit of Single Antiplatelet Therapy Over Dual Antiplatelet Therapy After Transcatheter Aortic Valve Implantation.

Am J Cardiol 2021 02 8;141:163-164. Epub 2020 Dec 8.

Department of Cardiovascular Medicine, Heart and Vascular Institute, Cleveland Clinic, Cleveland, Ohio. Electronic address:

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http://dx.doi.org/10.1016/j.amjcard.2020.12.010DOI Listing
February 2021
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