Publications by authors named "Samir Kapadia"

709 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

Safety and efficacy of the polymer-free and polymer-coated drug-eluting stents in patients undergoing percutaneous coronary intervention.

Catheter Cardiovasc Interv 2021 Sep 12. Epub 2021 Sep 12.

Department of Cardiology, Detroit Medical Center, Heart Hospital, Detroit, Michigan, USA.

Introduction: The relative safety and efficacy of polymer-free (PF) versus polymer-coated (PC) drug-eluting stents (DES) in patients with angina or acute coronary syndrome (ACS) undergoing percutaneous coronary intervention has received limited study.

Method: Digital databases were queried to identify relevant studies. Major adverse cardiovascular events (MACE) and secondary outcomes were compared using a random effect model to calculate unadjusted odds ratios (OR).

Results: A total of 28 studies consisting of 23,198 patients were included in the final analysis. On pooled analysis, there was no significant difference in the odds of MACE (OR 0.98, 95% CI 0.91-1.08) and major bleeding (OR 0.87, 95% CI 0.61-1.24) between patients undergoing PF-DES versus PC-DES. Similarly, the odds of myocardial infarction, stroke, stent thrombosis, cardiovascular mortality and need for target vessel revascularization was similar between the two groups. PF-DES was favored due to significantly lower odds of non-cardiac death (OR 0.78, 95% CI 0.68-89) and all-cause mortality (OR 0.87, 95% CI 0.80-0.95), but had a higher need for target lesion revascularization (OR 1.2, 95% CI 1.02-1.42). A subgroup analysis based on follow up duration, clinical presentation, presence of diabetes and class of eluting drugs mirrored the net estimates for all outcomes with a few exceptions. A sensitivity and meta-regression analysis showed no influence of single-study and duration of antiplatelet therapy on pooled outcomes.

Conclusion: In patients presenting with angina or ACS, PF-DES might be favored due to lower all-cause mortality and equal risk of ischemic adverse cardiovascular and major bleeding events compared with PC-DES.
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http://dx.doi.org/10.1002/ccd.29953DOI Listing
September 2021

Percutaneous Coronary Intervention Outcomes Based on Decision-Making Capacity.

J Am Heart Assoc 2021 Sep 28;10(17):e020609. Epub 2021 Aug 28.

Heart and Vascular Institute Cleveland Clinic Cleveland OH.

Background Long-term outcomes of percutaneous coronary intervention (PCI) based on patients' decision-making ability have not been studied. Our objective was to assess long-term outcomes after PCI in patients who provided individual versus surrogate consent. Methods and Results Data were collected retrospectively for patients who underwent PCI at Cleveland Clinic between January 1, 2015 and December 31, 2016. Inclusion criteria consisted of hospitalized patients aged ≥20 years who had PCI. Patients with outpatient PCI, or major surgery 30 days before or 90 days after PCI, were excluded. Patients who underwent PCI with surrogate consent versus individual consent were matched using the propensity analysis. Kaplan-Meier, log rank, -statistic, and χ tests were used for statistical analysis. The study was approved by the Institutional Review Board at Cleveland Clinic, Ohio. Of 3136 patients who underwent PCI during the study period, 183 had surrogate consent. Propensity matching yielded 149 patients from each group. Two-year all-cause mortality was significantly higher in the surrogate consent group (38 [25.5%] versus 16 [10.7%] deaths, log-rank =10.16, <0.001). The 2-year major adverse cardiac events rate was also significantly higher in the surrogate consent group (60 versus 36 events, log-rank =8.36, =0.003). Conclusions Patients with surrogate consent had significantly higher all-cause mortality and higher major adverse cardiac events when compared with patients with individual consent. This study emphasizes the fact that patients with an inability to give consent are at high risk and may need special attention in postprocedural and postdischarge care.
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http://dx.doi.org/10.1161/JAHA.120.020609DOI Listing
September 2021

Real-World Experience With the SAPIEN 3 Ultra Transcatheter Heart Valve: A Propensity-Matched Analysis From the United States.

Circ Cardiovasc Interv 2021 Aug 26:CIRCINTERVENTIONS121010543. Epub 2021 Aug 26.

Columbia University Irving Medical Center, NewYork-Presbyterian Hospital, New York City, NY (T.M.N., T.J.C., R.T.H., M.B.L., I.G.).

Background: Paravalvular regurgitation (PVR) after transcatheter aortic valve replacement is associated with adverse clinical outcomes. The SAPIEN 3 Ultra (Ultra) is a new generation balloon-expandable transcatheter heart valve with a modified external skirt that is designed to reduce PVR, but reports of clinical and echocardiographic outcomes are limited. The aim of this study was to compare short-term outcomes of patients undergoing transcatheter aortic valve replacement with the Ultra and the original SAPIEN 3 (S3) transcatheter heart valve in a large national registry.

Methods: Data from The Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry was used to compare patients who underwent elective, transfemoral transcatheter aortic valve replacement with the Ultra or S3 transcatheter heart valve. Clinical and echocardiographic outcomes were analyzed in a propensity-matched cohort at discharge and 30 days.

Results: Patients who underwent transcatheter aortic valve replacement with Ultra (N=1324) from January 2019 to February 2020 were propensity score-matched with patients treated with S3 (N=32 982) during the same period, resulting in 1324 matched pairs. There was no difference in the rate of device success between patients treated with Ultra and S3 (97.1% versus 98.0%, =0.11). At hospital discharge, PVR was significantly reduced with Ultra compared with S3, with mild PVR in 9.0% versus 13.9% and moderate or greater PVR in 0.1% versus 0.4% (overall <0.01). At 30 days, there were no differences between Ultra and S3 recipients in the rates of all-cause mortality or stroke (1.8% versus 2.8%, =0.10), major vascular complications (1.1% versus 1.0%, =0.84), or permanent pacemaker implantation (6.4% versus 6.2%, =0.81).

Conclusions: In this propensity-matched analysis from the Transcatheter Valve Therapy Registry, the Ultra transcatheter heart valve was associated with similar procedural and 30-day clinical outcomes, but reduced incidence of PVR, compared with S3. The clinical benefit of less PVR should be evaluated in longer-term studies.
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http://dx.doi.org/10.1161/CIRCINTERVENTIONS.121.010543DOI Listing
August 2021

Racial and Sex Disparities in Anticoagulation After Electrical Cardioversion for Atrial Fibrillation and Flutter.

J Am Heart Assoc 2021 Sep 25;10(17):e021674. Epub 2021 Aug 25.

Department of Internal Medicine University of Iowa Iowa City IA.

Background Anticoagulation is indicated for 4 weeks after cardioversion in patients with atrial fibrillation/flutter. We sought to examine whether there is evidence of sex or racial disparity in anticoagulant prescription following cardioversion, and whether postcardioversion anticoagulation affects outcomes. Methods and Results We identified a representative sample of Medicare patients who underwent elective electric cardioversion in an outpatient setting from 2015 to 2017. We identified patients who had an anticoagulant prescription for 3 months after the cardioversion date. Multivariable logistic regression was used to assess factors associated with a prescription of an anticoagulant after cardioversion. Cox regression analysis was used to test association of anticoagulation with a composite end point of 90-day mortality, ischemic stroke, or arterial embolism. The final study cohort included 7860 patients. Overall, 5510 patients (70.1%) received any anticoagulation following cardioversion, while 2350 (29.9%) did not. Patients who did not receive anticoagulation were younger, with a lower burden of most comorbidities. Patients were less likely to receive anticoagulation if they had dementia or atrial flutter, while patients with valvular heart disease, obesity, heart failure, peripheral vascular or coronary disease, or hypertension were more likely to receive anticoagulation. Female sex (adjusted odds ratio, 0.84; 95% CI, 0.75-0.92; <0.001), Black and Hispanic race (adjusted odds ratio, 0.50; 95% CI, 0.38-0.65; and odds ratio, 0.56; 95% CI, 0.41-0.75, respectively; <0.001) were independently associated with lower probability of anticoagulant prescription. Postcardioversion anticoagulation was associated with lower risk of the composite end point (adjusted hazard ratio, 0.38; 95% CI, 0.27-0.52; <0.001). Conclusions Racial and sex disparities exist in anticoagulant prescription after outpatient elective cardioversion for atrial fibrillation.
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http://dx.doi.org/10.1161/JAHA.121.021674DOI Listing
September 2021

30-day readmission following urgent and elective transcatheter aortic valve replacement: A Nationwide Readmission Database analysis.

Catheter Cardiovasc Interv 2021 Aug 19. Epub 2021 Aug 19.

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

Background: Transcatheter aortic valve replacement (TAVR) is being increasingly used for decompensated severe symptomatic aortic stenosis. Data on urgent and elective TAVR readmission is scarce in the literature. Here, we have performed a retrospective cohort study with the Nationwide Readmission Database of 2016 to identify the rate of 30-day all-cause readmission, common causes of readmission, and distribution of morbidity in index admission and readmission after urgent and elective TAVR.

Methods: We used International Classification of Diseases, Tenth Revision codes (02R.F38H, 02R.F38Z, 02R.F48Z) for identification of all TAVR procedures done in 2016 in patients >18 years old. We found 8379 patients who underwent urgent TAVR and 32,006 patients who underwent elective TAVR in 2016.

Result: The mean age of patients undergoing urgent TAVR was 79 ± 9.97 years with 44.6% women. The mean age of patients undergoing elective TAVR was 80.7 ± 8.25 years with 46.2% women. We found the 30-day all-cause readmission rate of 15.5% and 9.5% in patients undergoing urgent and elective TAVR, respectively (p < 0.001). The cardiac cause was the predominant cause of readmission in both groups (43.77% vs. 42.11%, p = 0.57), followed by pulmonary cause, gastrointestinal (GI) cause, and renal cause. Among cardiac causes, congestive heart failure (CHF) was predominant cause of readmission and was similar in both groups (18.73 in urgent TAVR vs. 15.73 in elective TAVR, p = 0.12).

Conclusion: We found that the all-cause 30-day readmission rate was higher in patients who had undergone urgent TAVR. Further studies are needed to better understand this difference.
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http://dx.doi.org/10.1002/ccd.29918DOI Listing
August 2021

Sex-Specific Outcomes of Transcatheter Mitral-Valve Repair and Medical Therapy for Mitral Regurgitation in Heart Failure.

JACC Heart Fail 2021 Sep 11;9(9):674-683. Epub 2021 Aug 11.

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: This study sought to assess the sex-specific outcomes in patients with heart failure (HF) with 3+ and 4+ secondary mitral regurgitation (SMR) treated with transcatheter mitral valve repair (TMVr) plus guideline-directed medical therapy (GDMT) versus GDMT alone in the COAPT trial.

Background: The impact of sex in patients with HF and severe SMR treated with TMVr with the MitraClip compared with GDMT alone is unknown.

Methods: Patients were randomized 1:1 to TMVr versus GDMT alone. Two-year outcomes were examined according to sex.

Results: Among 614 patients, 221 (36.0%) were women. Women were younger than men and had fewer comorbidities, but reduced quality of life and functional capacity at baseline. In a joint frailty model accounting for the competing risk of death, the 2-year cumulative incidence of the primary endpoint of all HF hospitalizations (HFH) was higher in men compared with women treated with GDMT alone. However, the relative reduction in HFHs with TMVr was greater in men (HR: 0.43; 95% CI: 0.34-0.54) than women (HR: 0.78; 95% CI: 0.57-1.05) (P = 0.002). A significant interaction between TMVr versus GDMT alone treatment and time was present for all HFHs in women (HR: 0.57; 95% CI: 0.39-0.84, and HR: 1.39; 95% CI: 0.83-2.33 between 0-1 year and 1-2 years after randomization, respectively, P = 0.007) but not in men (HR: 0.48; 95% CI: 0.36-0.64, and HR: 0.33; 95% CI: 0.21-0.51; P = 0.16). Female sex was independently associated with a lower adjusted risk of death at 2 years (HR: 0.64; 95% CI: 0.46-0.90; P = 0.011). TMVr consistently reduced 2-year mortality compared with GDMT alone, irrespective of sex (P = 0.99).

Conclusions: In the COAPT trial, TMVr with the MitraClip resulted in improved clinical outcomes compared with GDMT alone, irrespective of sex. However, the impact of TMVr in reducing HFH was less pronounced in women compared with men beyond the first year after treatment. (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation [The COAPT Tria] [COAPT]; NCT01626079).
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http://dx.doi.org/10.1016/j.jchf.2021.04.011DOI Listing
September 2021

MitraClip in Patients With and Without Cardiac Resynchronization Therapy.

Am J Cardiol 2021 Aug 7. Epub 2021 Aug 7.

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.2021.07.006DOI Listing
August 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

Cardiac risk stratification in cancer patients: A longitudinal patient-patient network analysis.

PLoS Med 2021 Aug 2;18(8):e1003736. Epub 2021 Aug 2.

Genomic Medicine Institute, Lerner Research Institute, Cleveland Clinic, Cleveland, Ohio, United States of America.

Background: Cardiovascular disease is a leading cause of death in general population and the second leading cause of mortality and morbidity in cancer survivors after recurrent malignancy in the United States. The growing awareness of cancer therapy-related cardiac dysfunction (CTRCD) has led to an emerging field of cardio-oncology; yet, there is limited knowledge on how to predict which patients will experience adverse cardiac outcomes. We aimed to perform unbiased cardiac risk stratification for cancer patients using our large-scale, institutional electronic medical records.

Methods And Findings: We built a large longitudinal (up to 22 years' follow-up from March 1997 to January 2019) cardio-oncology cohort having 4,632 cancer patients in Cleveland Clinic with 5 diagnosed cardiac outcomes: atrial fibrillation, coronary artery disease, heart failure, myocardial infarction, and stroke. The entire population includes 84% white Americans and 11% black Americans, and 59% females versus 41% males, with median age of 63 (interquartile range [IQR]: 54 to 71) years old. We utilized a topology-based K-means clustering approach for unbiased patient-patient network analyses of data from general demographics, echocardiogram (over 25,000), lab testing, and cardiac factors (cardiac). We performed hazard ratio (HR) and Kaplan-Meier analyses to identify clinically actionable variables. All confounding factors were adjusted by Cox regression models. We performed random-split and time-split training-test validation for our model. We identified 4 clinically relevant subgroups that are significantly correlated with incidence of cardiac outcomes and mortality. Among the 4 subgroups, subgroup I (n = 625) has the highest risk of de novo CTRCD (28%) with an HR of 3.05 (95% confidence interval (CI) 2.51 to 3.72). Patients in subgroup IV (n = 1,250) had the worst survival probability (HR 4.32, 95% CI 3.82 to 4.88). From longitudinal patient-patient network analyses, the patients in subgroup I had a higher percentage of de novo CTRCD and a worse mortality within 5 years after the initiation of cancer therapies compared to long-time exposure (6 to 20 years). Using clinical variable network analyses, we identified that serum levels of NT-proB-type Natriuretic Peptide (NT-proBNP) and Troponin T are significantly correlated with patient's mortality (NT-proBNP > 900 pg/mL versus NT-proBNP = 0 to 125 pg/mL, HR = 2.95, 95% CI 2.28 to 3.82, p < 0.001; Troponin T > 0.05 μg/L versus Troponin T ≤ 0.01 μg/L, HR = 2.08, 95% CI 1.83 to 2.34, p < 0.001). Study limitations include lack of independent cardio-oncology cohorts from different healthcare systems to evaluate the generalizability of the models. Meanwhile, the confounding factors, such as multiple medication usages, may influence the findings.

Conclusions: In this study, we demonstrated that the patient-patient network clustering methodology is clinically intuitive, and it allows more rapid identification of cancer survivors that are at greater risk of cardiac dysfunction. We believed that this study holds great promise for identifying novel cardiac risk subgroups and clinically actionable variables for the development of precision cardio-oncology.
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http://dx.doi.org/10.1371/journal.pmed.1003736DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8366997PMC
August 2021

Characteristics and Outcomes of Early Recurrent Myocardial Infarction After Acute Myocardial Infarction.

J Am Heart Assoc 2021 Aug 2;10(16):e019270. Epub 2021 Aug 2.

Cleveland Clinic Heart, Vascular and Thoracic Institute Cleveland OH.

Background We aimed to understand the characteristics and outcomes of patients readmitted with a recurrent myocardial infarction (RMI) within 90 days of discharge after an acute myocardial infarction (early RMI). Methods and Results We analyzed the timing of reinfarction, etiology, and outcome for all patients admitted with an early RMI within 90 days of discharge after an acute myocardial infarction between January 1, 2010 and January 1, 2017. We identified 6626 admissions for acute myocardial infarction (index myocardial infarction) which led to 168 cases of RMI within 90 days of discharge. The mean patient age was 65.1±13.1 years, and 37% were women. The 90-day probability of readmission with an early RMI was 2.5%. Black race, medical management, higher troponin T, and shorter length of stay were independent predictors of early RMI. Medically managed group had a higher risk for early RMI compared with percutaneous coronary intervention (=0.04) or coronary artery bypass grafting (=0.2). Predominant mechanisms for reinfarction were stent thrombosis (17%), disease progression (12%), and unchanged coronary artery disease (11%). At 5 years, the all-cause mortality rate for patients with an early RMI was 49% (95% CI, 40%-57%) compared with 22% (95% CI, 21%-23%) for patients without an early RMI (<0.0001). Conclusions Early RMI is a life-threatening condition with nearly 50% mortality within 5 years. Stent-related events and progression in coronary artery disease account for most early RMI. Medication compliance, aggressive risk factor management, and care transitions should be the cornerstone in preventing early RMI.
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http://dx.doi.org/10.1161/JAHA.120.019270DOI Listing
August 2021

Transcatheter Closure of Left Ventricular Outflow Tract-to-Left Atrium Fistula.

JACC Case Rep 2021 May 19;3(5):760-765. Epub 2021 May 19.

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

Surgical and rarely transcatheter aortic valve replacement can be complicated by intracardiac fistula. Transcatheter closure of those shunts has been previously reported with favorable results. We describe a case of percutaneous closure of left ventricular outflow tract-to-left atrium fistula after surgical aortic valve replacement using an Amplatzer Vascular Plug II. ().
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http://dx.doi.org/10.1016/j.jaccas.2021.02.040DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8311196PMC
May 2021

Transcatheter Heart Valve Thrombosis in a Patient With Polycythemia Vera Despite Apixaban Therapy for Atrial Fibrillation.

JACC Case Rep 2021 Feb 17;3(2):269-272. Epub 2021 Feb 17.

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

We present a case of transcatheter heart valve thrombosis in a 76-year-old man with paroxysmal atrial fibrillation on therapeutic anticoagulation with apixaban and polycythemia vera. The incidence of transcatheter heart valve thrombosis in patients with atrial fibrillation and on adequate anticoagulation is not well reported. ().
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http://dx.doi.org/10.1016/j.jaccas.2020.12.015DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8310972PMC
February 2021

Surgical Repair for Primary Tricuspid Valve Disease: Individualized Surgical Planning With 3-Dimensional Printing.

JACC Case Rep 2020 Nov 18;2(14):2217-2222. Epub 2020 Nov 18.

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

Primary tricuspid valve (TV) disease is rare and associated with high operative mortality. Optimal surgical planning requires a precise understanding of the pathological features; however, detailed imaging of the TV can be challenging. We present 4 cases of primary TV disease where 3-dimensional printing was pivotal to operative planning and success. ().
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http://dx.doi.org/10.1016/j.jaccas.2020.09.047DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8299861PMC
November 2020

Same-Day Discharge After Transcatheter Native Aortic and Mitral Valve-in-Valve Replacement.

JACC Case Rep 2020 Nov 18;2(14):2199-2201. Epub 2020 Nov 18.

Department of Cardiovascular Medicine, Cleveland Clinic Foundation, Cleveland, Ohio.

Transcatheter aortic valve replacement has become the gold standard of care in the management of patients with severe aortic stenosis and transcatheter mitral valve-in-valve replacement seems to be an attractive alternative to redo surgery. We report the first case of concomitant transcatheter aortic valve replacement/transcatheter mitral valve-in-valve replacement that was performed under conscious sedation who was subsequently discharged the same day. ().
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http://dx.doi.org/10.1016/j.jaccas.2020.09.036DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8299845PMC
November 2020

Coronavirus disease and the cardiovascular system: a narrative review of the mechanisms of injury and management implications.

Cardiovasc Diagn Ther 2021 Jun;11(3):939-953

Robert and Suzanne Tomsich Department of Cardiovascular Medicine, Sydell and Arnold Miller Family Heart, Vascular and Thoracic Institute, Cleveland Clinic Foundation, Cleveland, OH, USA.

Coronavirus disease (COVID-19), first identified in Wuhan, China, in December 2019, is now a pandemic, having already spread to 188 countries, with more than 28,280,000 infections worldwide. Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) is the responsible infectious agent, and similar to other human coronaviruses, uses membrane-bound angiotensin-converting enzyme 2 (membrane-bound ACE2) for entry into the host cells. COVID-19 has important cardiovascular implications, especially for patients with pre-existing cardiovascular co-morbidities, potentially mediated through several mechanisms, including direct myocardial injury, worsening of those pre-existing cardiovascular co-morbidities, and adverse cardiovascular effects of potential therapies for COVID-19. The disease is causing a significant burden on health systems worldwide. Elective surgeries and procedures were postponed for a considerable period of time, and many patients with known cardiovascular disease (CVD) risk factors presented late to hospitals, for fear of contracting COVID-19, with serious adverse consequences. Significant negative impact on a population level is highlighted by prolonged isolation, decreased exercise and physical activity, and higher levels of depression and anxiety, all predisposing to elevated cardiovascular risk. This article provides a timely overview of COVID-19 and its impact on the cardiovascular system, focusing on the pathogenesis, potential adverse cardiovascular events, the potential treatment options, protection for health care providers and patients, and what the cardiovascular community could do to mitigate the impact of COVID-19.
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http://dx.doi.org/10.21037/cdt-20-779DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8261751PMC
June 2021

Postoperative Atrial Fibrillation or Flutter Following Transcatheter or Surgical Aortic Valve Replacement: PARTNER 3 Trial.

JACC Cardiovasc Interv 2021 Jul;14(14):1565-1574

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

Objectives: The aim of this study was to assess the incidence and prognostic impact of early and late postoperative atrial fibrillation or flutter (POAF) in patients with severe aortic stenosis (AS) treated with transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR).

Background: There is an ongoing controversy regarding the incidence, recurrence rate, and prognostic impact of early (in-hospital) POAF and late (postdischarge) POAF in patients with AS undergoing TAVR or SAVR.

Methods: In the PARTNER (Placement of Aortic Transcatheter Valve) 3 trial, patients with severe AS at low surgical risk were randomized to TAVR or SAVR. Analyses were performed in the as-treated population excluding patients with preexistent atrial fibrillation or flutter.

Results: Among 781 patients included in the analysis, early POAF occurred in 152 (19.5%) (18 of 415 [4.3%] and 134 of 366 [36.6%] following TAVR and SAVR, respectively). Following discharge, 58 new or recurrent late POAF events occurred within 1 year following the index procedure in 55 of 781 patients (7.0%). Early POAF was not an independent predictor of late POAF following discharge (odds ratio: 1.04; 95% CI: 0.52-2.08; P = 0.90). Following adjustment, early POAF was not an independent predictor of the composite outcome of death, stroke, or rehospitalization (hazard ratio: 1.10; 95% CI: 0.64-1.92; P = 0.72), whereas late POAF was associated with an increased adjusted risk for the composite outcome (hazard ratio: 8.90; 95% CI: 5.02-15.74; P < 0.0001), irrespective of treatment modality.

Conclusions: In the PARTNER 3 trial, early POAF was more frequent following SAVR compared with TAVR. Late POAF, but not early POAF, was significantly associated with worse outcomes at 2 years, irrespective of treatment modality.
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http://dx.doi.org/10.1016/j.jcin.2021.05.026DOI Listing
July 2021

Bioprosthetic valves and atrial fibrillation: Direct anticoagulants or warfarin.

J Thorac Cardiovasc Surg 2021 Jun 26. Epub 2021 Jun 26.

Department of Thoracic and Cardiovascular Surgery, Heart, Vascular, and Thoracic Institute, Cleveland Clinic, Cleveland, Ohio; Aorta Center, Heart, Vascular, and Thoracic Institute, Cleveland Clinic, Cleveland, Ohio. Electronic address:

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http://dx.doi.org/10.1016/j.jtcvs.2021.05.051DOI Listing
June 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

Incidence and Clinical Significance of Worsening Tricuspid Regurgitation Following Surgical or Transcatheter Aortic Valve Replacement: Analysis From the PARTNER IIA Trial.

Circ Cardiovasc Interv 2021 Aug 16;14(8):e010437. Epub 2021 Jul 16.

Section of Cardiovascular Imaging, Department of Cardiovascular Medicine, Heart, Vascular and Thoracic Institute, Cleveland Clinic, OH (P.C.C., T.K.M.W., L.L.R., W.A.J.).

[Figure: see text].
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http://dx.doi.org/10.1161/CIRCINTERVENTIONS.120.010437DOI Listing
August 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

Doppler Velocity Index Outcomes Following Surgical or Transcatheter Aortic Valve Replacement in the PARTNER Trials.

JACC Cardiovasc Interv 2021 Jul 30;14(14):1594-1606. Epub 2021 Jun 30.

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

Objectives: The aim of this study was to assess the association between Doppler velocity index (DVI) and 2-year outcomes for balloon-expandable SAPIEN 3 transcatheter aortic valve replacement (TAVR) and for surgical aortic valve replacement (SAVR).

Background: DVI >0.35 is normal for a prosthetic valve, but recent studies suggest that DVI <0.50 is associated with poor outcomes following TAVR.

Methods: Patients with severe aortic stenosis enrolled in the PARTNER (Placement of Aortic Transcatheter Valve) 2 (intermediate surgical risk) or PARTNER 3 (low surgical risk) trial undergoing TAVR (n = 1,450) or SAVR (n = 1,303) were included. Patients were divided into 3 DVI groups on the basis of core laboratory-assessed discharge or 30-day echocardiograms: DVI (≤0.35), DVI (>0.35 to ≤0.50), and DVI (>0.50). Two-year outcomes were assessed.

Results: Following TAVR, there were no differences among the 3 DVI groups in composite outcomes of death, stroke, or rehospitalization or in any individual components of 2-year outcomes (P > 0.70 for all). Following SAVR, there was no difference among DVI groups in the composite outcome (P = 0.27), but there was a significant association with rehospitalization (P = 0.02). Restricted cubic-spline analysis for combined outcomes showed an increased risk with post-SAVR DVI ≤0.35 but no relationship post-TAVR. DVI ≤0.35 was associated with increased 2-year composite outcome for SAVR (HR: 1.81; 95% CI: 1.29-2.54; P < 0.001), with no adverse outcomes for TAVR (P = 0.86).

Conclusions: In intermediate- and low-risk cohorts of the PARTNER trials, DVI ≤0.35 predicted worse 2-year outcomes following SAVR, driven primarily by rehospitalization, with no adverse outcomes associated with DVI following TAVR with the balloon-expandable SAPIEN 3 valve.
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http://dx.doi.org/10.1016/j.jcin.2021.04.007DOI Listing
July 2021

Association of hospital procedural volume with incidence and outcomes of surgical bailout in patients undergoing transcatheter aortic valve replacement.

Catheter Cardiovasc Interv 2021 Jun 29. Epub 2021 Jun 29.

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

Objectives: This study sought to examine the association of hospital procedural volume with the incidence and outcomes of surgical bailout (SB) in patients who undergo transcatheter aortic valve replacement (TAVR).

Background: SB is required for serious complications during or after TAVR. It remains unclear whether hospital experiences affect the incidence and outcomes of SB.

Methods: We retrospectively identified patients who underwent endovascular TAVR using the Nationwide Readmissions Database 2012-2017. We examined the association of annual hospital procedural volume (annual number of endovascular TAVR cases in each hospital in each year) with the incidence and in-hospital mortality of SB using multivariable logistic regressions and restricted cubic splines.

Results: Among 82,764 eligible patients, the incidence of SB was 0.95% (n = 789) and decreased from 2012 to 2017 (from 2.66% to 0.49%; P  < 0.001), while in-hospital mortality of SB remained high over years (from 26.0% to 23.5%; P  = 0.773). Very-high-volume hospitals (≥200 cases/year), as compared with low-volume hospitals (≤49 cases/year), showed significantly a lower incidence of SB (0.49% vs. 1.81%; adjusted OR = 0.28, 95% CI = 0.21-0.38), but similar in-hospital mortality of SB (26.2% vs. 25.6%; adjusted OR = 0.88, 95% CI = 0.47-1.66). There was a significant nonlinear, inverse association of hospital volume with the incidence of SB, but not with the in-hospital mortality of SB.

Conclusions: Hospitals with higher TAVR volumes have a lower risk of SB, but the in-hospital mortality after SB does not change with hospital TAVR volume. Our findings highlight the importance that physicians should always be aware of the high mortality risk of SB following TAVR regardless of hospital procedural experiences.
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http://dx.doi.org/10.1002/ccd.29847DOI Listing
June 2021
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