Publications by authors named "Mehdi H Shishehbor"

224 Publications

Endovascular Treatment and Outcomes for Femoropopliteal In-Stent Restenosis: Insights from the XLPAD Registry.

J Interv Cardiol 2022 15;2022:5935039. Epub 2022 Jul 15.

University of Texas Southwestern Medical Center, Dallas, TX, USA.

Background: There is limited "real-world" evidence examining treatment modalities and outcomes in patients with symptomatic peripheral arterial disease undergoing endovascular treatment of femoropopliteal (FP) in-stent restenosis (ISR).

Materials And Methods: We compared outcomes in 2,895 patients from the XLPAD registry (NCT01904851) between 2006 and 2019 treated for FP ISR ( = 347) and non-ISR ( = 2,548) lesions. Primary endpoint included major adverse limb events (MALE) at 1 year, a composite of all-cause death, target limb repeat revascularization, or major amputation.

Results: ISR patients were more frequently on antiplatelet (94.5% vs 89.4%, =0.007) and statin (68.9% vs 60.3%, =0.003) therapies. Lesion length was similar (ISR: 145 ± 99 mm vs. non-ISR: 142 ± 99 mm, =0.55). Fewer treated ISR lesions were chronic total occlusions (47.3% vs. 53.7%, =0.02) and severely calcified (22.4% vs. 44.7%, < 0.001). Atherectomy (63.5% vs. 45.0%, < 0.001) and drug-coated balloons (DCB; 4.7% vs. 1.7%, < 0.001) were more frequently used in ISR lesions. The distal embolization rate was higher in ISR lesions (2.4% vs. 0.9%, =0.02). Repeat revascularization (21.5% vs. 16.7%, =0.04; Figure) was higher and freedom from MALE at 1 year was significantly lower (87% vs. 92.5%, < 0.001) in the ISR group.

Conclusion: Atherectomy and DCB are more frequently used to treat FP ISR lesions. Patients with FP ISR have more intraprocedural distal embolization, higher repeat revascularization procedures, and lower freedom from MALE at 1 year.
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http://dx.doi.org/10.1155/2022/5935039DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC9307356PMC
August 2022

Proportionate and Absolute Vascular Disease Mortality by Race and Sex in the United States From 1999 to 2019.

J Am Heart Assoc 2022 Aug 19;11(15):e025276. Epub 2022 Jul 19.

Department of Medicine University Hospitals Cleveland OH.

Background Despite the known significant morbidity and mortality associated with cardiovascular disease and peripheral vascular disease (PVD), contemporary data describing racial demographics in PVD mortality are scarce. Methods and Results Using the multiple causes of death file from the Centers for Disease Control and Prevention's Wide-Ranging Online Data for Epidemiologic Research, we analyzed the trends of age-adjusted mortality (AAMR) for PVD and its subtypes (aortic aneurysm/dissection, arterial thrombosis, venous thrombosis/disease, pulmonary embolism), by race and sex between 1999 and 2019. Of the 17 826 871 deaths attributed to cardiovascular disease, a total of 888 187 (5.0%) PVD deaths were analyzed during the study period (12.4% Black, 85.6% White). Between 1999 and 2019, AAMR for PVD decreased by 52% (24.8-11.8 per 100 000 people) in the overall population. Despite a decrease in the overall mortality across all race and sex groups, Black men and Black women continued to have higher mortality for PVD (1.5×), aortic dissection (1.8×), arterial thrombosis (1.3×), and venous thrombosis/disease (2.0×) mortality compared with White men and White women in 2019. While there was a 53% decrease in PVD among White individuals (AAMR 24.5-11.5 per 100 000), there was only a 43% decrease (30.0-17.1) in PVD AAMR in Black individuals between 1999 and 2019. The ratio of PVD AAMR increased from 1.2 (1999) to 1.5 (2019) in Black men/White men and from to 1.3 (1999) to 1.5 (2019) in Black women/White women. Similar trends were noted in aortic dissection (Black men/White men, 1.2-1.8; and Black women/White women, 1.5-1.7), arterial thrombosis (Black men/White men, 1.0-1.3; and Black women/White women, 0.9-1.3), and venous thrombosis/disease (Black men/White men, 1.7-1.8; and Black women/White women, 1.7-2.0). Conclusions In this retrospective review of death certificate data in the United States, we demonstrate continued significant disparities between Black and White populations in PVD mortality and its subtypes. Future studies should investigate etiologies and social determinants of PVD mortality.
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http://dx.doi.org/10.1161/JAHA.121.025276DOI Listing
August 2022

Percutaneous mechanical thrombectomy and extracorporeal membranous oxygenation: A case series.

Catheter Cardiovasc Interv 2022 08 10;100(2):274-278. Epub 2022 Jun 10.

Harrington Heart and Vascular Institute, University Hospital Cleveland Medical Center, Cleveland, Ohio, USA.

Background: Massive or high-risk pulmonary embolism (PE) is a potentially life-threatening diagnosis with significant morbidity and mortality if treatment is delayed. Extracorporeal membrane oxygenation (ECMO) and large bore thrombectomy (LBT) in isolation have been used to stabilize and treat patients with massive PE, however, literature describing the combination of both modalities is lacking. We present a case series involving 9 patients who underwent combined ECMO and LBT and their outcomes.

Methods: This was a retrospective chart review of patients with confirmed PE, who underwent LBT and ECMO. We retrospectively captured clinical, therapeutic, and outcome data at the time of pulmonary embolism response team (PERT) activation and during the follow-up period for up to 90 days.

Results: Nine patients who had PERT activation with confirmed PE diagnosis have undergone combined LBT and ECMO initiation since the advent of our PERT program. The median age was 57 (range 28-68) years. Six patients out of 9 (55%) had cardiac arrest before therapy. All patients exhibited right heart strain on computed tomography and echocardiogram. The median ECMO duration was 5 days (range 2.3-11.6 days), with mean hospitalization of 16.1 days (range 1.5-30.9). Mortality was 22% at 90-day follow-up period.

Conclusion: Patients with massive pulmonary embolism who suffer cardiac arrest have significant morbidity and mortality. ECMO in combination with LBT is a viable treatment option for patients with significant hemodynamic compromise.
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http://dx.doi.org/10.1002/ccd.30295DOI Listing
August 2022

Contemporary National Trends and Outcomes of Pulmonary Embolism in the United States.

Am J Cardiol 2022 08 28;176:132-138. Epub 2022 May 28.

Harrington Heart and Vascular Institute and Case Western Reserve University School of Medicine, University Hospitals, Cleveland, Ohio. Electronic address:

Contemporary data on the national trends in pulmonary embolism (PE) admissions and outcomes are scarce. We aimed to analyze trends in mortality and different treatment methods in acute PE. We queried the Nationwide Readmissions Database (2016 to 2019) to identify hospitalizations with acute PE using the International Classification of Diseases, Tenth Revision, Clinical Modification codes. We described the national trends in admissions, in-hospital mortality, readmissions, and different treatment methods in acute PE. We identified 1,427,491 hospitalizations with acute PE, 2.4% of them (n = 34,446) were admissions with high-risk PE. The rate of in-hospital mortality in all PE hospitalizations was 6.5%, and it remained unchanged throughout the study period. However, the rate of in-hospital mortality in high-risk PE decreased from 48.1% in the first quarter of 2016 to 38.9% in the last quarter of 2019 (p-trend <0.001). The rate of urgent 30-day readmission was 15.2% in all PE admissions and 19.1% in high-risk PE admissions. In all PE admissions, catheter-directed interventions (CDI) were used more often (2.5%) than systemic thrombolysis (ST) (2.1%). However, in admissions with high-risk PE, ST remained the most frequently used method (ST vs CDI: 11.3% vs 6.6%). In conclusion, this study showed that the rate of in-hospital mortality in high-risk PE decreased from 2016 to 2019. ST was the most frequently used method for achieving pulmonary reperfusion in high-risk PE, whereas CDI was the most frequently used method in the entire PE cohort. In-hospital death and urgent readmissions rates remain significantly high in patients with high-risk PE.
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http://dx.doi.org/10.1016/j.amjcard.2022.03.060DOI Listing
August 2022

Timing of Repair in Postinfarction Ventricular Septal Defect.

Am J Cardiol 2022 07 18;175:44-51. Epub 2022 May 18.

Harrington Heart and Vascular Institute, Case Western Reserve University, Cleveland, Ohio. Electronic address:

The optimal timing of postinfarction ventricular septal defect (PI-VSD) repair is subject to debate. Patients with ventricular septal defect (VSD) and ST-elevation myocardial infarction (STEMI) were queried using appropriate International Classification of Diseases, Ninth and Tenth Revision Clinical Modification codes from the National Inpatient Sample (2003 to 2018). VSD repair was identified using appropriate International Classification of Diseases, Ninth and Tenth Revision Procedure Coding System codes. Data were stepwise stratified by cardiogenic shock (CS) and time of repair from admission to create 6 clinically relevant groups: shock 1 (CS; 0 to 7 days), shock 2 (CS; 8 to 14 days), and shock 3 (CS; >14 days). Nonshock groups were classified similarly. The primary outcome was in-hospital mortality. Multilevel hierarchical logistic regression was used to adjust for confounders for each group. We identified 10,902 patients with PI-VSD. In shock 1 (n = 5,794), VSD repair was associated with lower mortality (OR 0.76; 95% CI 0.68 to 0.86, p <0.001) compared to no VSD repair. In shock 2 (n=1,009) mortality was numerically lower in those who received VSD repair, but not statistically different. In shock 3 (n=483), mortality was numerically higher in those who received VSD repair, but not statistically different. In nonshock 1 (n=5,108), VSD repair was associated with higher mortality (odds ratio [OR] 1.59; 95% confidence interval [CI] 1.33 to 1.90; p <0.001). In nonshock 2 (n = 1,265), mortality was numerically higher in patients with VSD repair, although not statistically different. In nonshock 3 (n = 472), mortality was numerically lower in patients with VSD repair, although not statistically different. Mechanical circulatory support use increased over the 16 years (relative change + 18%, p <0.001), with no significant change in mortality among patients with PI-VSD. In conclusion, in patients with CS, early PI-VSD repair was associated with lower mortality. However, in patients without CS, early PI-VSD repair was associated with higher mortality.
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http://dx.doi.org/10.1016/j.amjcard.2022.04.017DOI Listing
July 2022

Case series of closure devices complications.

Catheter Cardiovasc Interv 2022 08 29;100(2):290-294. Epub 2022 Apr 29.

Harrington Heart and Vascular Institute, University Hospital Cleveland Medical Center, Cleveland, Ohio, USA.

Vascular closure devices (VCD) are effective at achieving hemostasis. VCD failure is attributed to underlying arterial disease, leading to a hazardous situation for obtaining contralateral femoral access. Radial-to-peripheral (R2P) access has emerged as a safe option to rescue these procedural complications. Here, we present two cases of VCD failure rescue utilizing R2P and outline this approach step-by-step.
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http://dx.doi.org/10.1002/ccd.30214DOI Listing
August 2022

Routine Use of the "Penumbra" Thrombectomy Device in Myocardial Infarction: A Real-World Experience-ROPUST Study.

J Interv Cardiol 2022 26;2022:5692964. Epub 2022 Mar 26.

Harrington Heart and Vascular Institute, University Hospitals Cleveland Medical Center, Cleveland, OH, USA.

Objectives: Evaluation of the safety and efficacy of the Penumbra device as an adjunct to percutaneous coronary intervention (PCI) in patients with myocardial infarction (MI) and a large thrombus burden that requires thrombectomy.

Background: For patients with acute MI, PCI is the primary reperfusion method. Large thrombus burden has always been a limitation of successful reperfusion. However, the use of current aspiration devices has been associated with an increased incidence of stroke.

Methods: We performed a retrospective chart review at the University Hospitals Medical Center in Cleveland. Our study included data from patients who underwent PCI for ST segment elevation myocardial infarction (STEMI) and non-ST segment elevation myocardial infarction (NSTEMI) assisted by the Penumbra Cat RX device (a wide-lumen thrombus aspiration catheter) between May 2019 and February 2021. The primary outcome was the final thrombolysis in myocardial infarction (TIMI) flow. The secondary endpoints were a composite of adverse cardiac events at 6 months. About 50% of the patients did undergo transfemoral PCI as per preference of individual operators. The Penumbra thrombectomy device can be used both by radial and femoral approach and does not need any different guide catheter use.

Results: TIMI flow 3 was achieved in 111 patients (90.2%). The secondary endpoint occurred in 11 patients (8.9%, 3 MI, 8 heart failure hospitalizations). There were no stroke events or device-related complications. The door-to-balloon time was not affected by usage of the Penumbra device. Failure in the restoration of TIMI 3 flow was associated with the use of balloon angioplasty prior to the application of the Penumbra device, leading to distal embolization.

Conclusions: The Penumbra Cat RX provides safe and effective thrombus removal with better clinical outcomes, even in high-risk patients with acute coronary syndrome.
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http://dx.doi.org/10.1155/2022/5692964DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8976598PMC
April 2022

Randomized Trial of Chocolate Touch Compared With Lutonix Drug-Coated Balloon in Femoropopliteal Lesions (Chocolate Touch Study).

Circulation 2022 05 4;145(22):1645-1654. Epub 2022 Apr 4.

Yale University School of Medicine, New Haven, CT (H.P., C.P., D.T., A.J.L.).

Background: First-generation drug-coated balloons (DCBs) have significantly reduced the rate of restenosis compared with balloon angioplasty alone; however, high rates of bailout stenting and dissections persist. The Chocolate Touch DCB is a nitinol constrained balloon designed to reduce acute vessel trauma and inhibit neointima formation and restenosis.

Methods: Patients with claudication or ischemic rest pain (Rutherford class 2-4) and superficial femoral or popliteal disease (≥70% stenosis) were randomized 1:1 to Chocolate Touch or Lutonix DCB at 34 sites in the United States, Europe, and New Zealand. The primary efficacy end point was DCB success, defined as primary patency at 12 months (peak systolic velocity ratio <2.4 by duplex ultrasound without clinically driven target lesion revascularization in the absence of clinically driven bailout stenting). The primary safety end point was freedom from major adverse events at 12 months, a composite of target limb-related death, major amputation, or reintervention. Both primary end points were tested for noninferiority, and if met, sequential superiority testing for efficacy followed by safety was prespecified. An independent clinical events committee, and angiographic and duplex ultrasound core laboratories blinded to treatment allocation reviewed all end points.

Results: A total of 313 patients were randomized to Chocolate Touch (n=152) versus Lutonix DCB (n=161). Follow-up at 1 year was available in 94% of patients. The mean age was 69.4±9.5 years, the average lesion length was 78.1±46.9 mm, and 46.2% had moderate-to-severe calcification. The primary efficacy rates of DCB success at 12 months was 78.8% (108/137) with Chocolate Touch and 67.7% (88/130) with Lutonix DCB (difference, 11.1% [95% CI, 0.6-21.7]), meeting noninferiority (<0.0001) and sequential superiority (=0.04). The primary safety event rate was 88.9% (128/144) with Chocolate Touch and 84.6% (126/149) with Lutonix DCB (<0.001; =0.27).

Conclusions: In this prospective, multicenter, randomized trial, the second-generation Chocolate Touch DCB met both noninferiority end points for efficacy and safety and was more effective than Lutonix DCB at 12 months for the treatment of femoropopliteal disease.

Registration: URL: https://www.

Clinicaltrials: gov; Unique identifier: NCT02924857.
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http://dx.doi.org/10.1161/CIRCULATIONAHA.122.059646DOI Listing
May 2022

Peripheral Artery Disease: The New and Old Silent Killer.

J Am Coll Cardiol 2022 04;79(13):1236-1238

Harrington Heart and Vascular Institute, University Hospitals, and Case Western Reserve University, Cleveland, Ohio, USA.

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http://dx.doi.org/10.1016/j.jacc.2022.02.006DOI Listing
April 2022

The shifting care and outcomes for patients with endangered limbs - Critical limb ischemia (SCOPE-CLI) registry overview of study design and rationale.

Int J Cardiol Heart Vasc 2022 Apr 12;39:100971. Epub 2022 Feb 12.

Yale University, Department of Internal Medicine, Vascular Medicine Outcomes Program (VAMOS), New Haven, CT, United States.

Background: Critical limb ischemia (CLI), the most severe form of peripheral artery disease, is associated with pain, poor wound healing, high rates of amputation, and mortality (>20% at 1 year). Little is known about the processes of care, patients' preferences, or outcomes, as seen from patients' perspectives. The SCOPE-CLI study was co-designed with patients to holistically document patient characteristics, treatment preferences, patterns of care, and patient-centered outcomes for CLI.

Methods: This 11-center prospective observational registry will enroll and interview 816 patients from multispecialty, interdisciplinary vascular centers in the United States and Australia. Patients will be followed up at 1, 2, 6, and 12 months regarding their psychosocial factors and health status. Hospitalizations, interventions, and outcomes will be captured for 12 months with vital status extending to 5 years. Pilot data were collected between January and July of 2021 from 3 centers.

Results: A total of 70 patients have been enrolled. The mean age was 68.4 ± 11.3 years, 31.4% were female, and 20.0% were African American.

Conclusions: SCOPE-CLI is uniquely co-designed with patients who have CLI to capture the care experiences, treatment preferences, and health status outcomes of this vulnerable population and will provide much needed information to understand and address gaps in the quality of CLI care and outcomes.ClinicalTrials.gov identifier (NCT Number): NCT04710563 https://clinicaltrials.gov/ct2/show/NCT04710563.
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http://dx.doi.org/10.1016/j.ijcha.2022.100971DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8850321PMC
April 2022

Association of Disease-Specific Health Status With Long-Term Survival in Peripheral Artery Disease.

J Am Heart Assoc 2022 02 8;11(4):e022232. Epub 2022 Feb 8.

Vascular Medicine Outcomes Program Section of Cardiovascular Medicine Department of Internal Medicine Yale University New Haven CT.

Background While peripheral artery disease (PAD) is associated with increased cardiovascular morbidity with mortality remaining high and challenging to predict, accurate understanding of serial PAD-specific health status around the time of diagnosis may prognosticate long-term mortality risk. Methods and Results Patients with new or worsening PAD symptoms enrolled in the PORTRAIT Registry across 10 US sites from 2011 to 2015 were included. Health status was assessed by the Peripheral Artery Questionnaire (PAQ) Summary score at baseline, 3-month, and change from baseline to 3-month follow-up. Kaplan-Meier using 3-month landmark and hierarchical Cox regression models were constructed to assess the association of the PAQ with 5-year all-cause mortality. Of the 711 patients (mean age 68.8±9.6 years, 40.9% female, 72.7% white; mean PAQ 47.5±22.0 and 65.9±25.0 at baseline and 3-month, respectively), 141 (19.8%) died over a median follow-up of 4.1 years. In unadjusted models, baseline (HR, 0.90 per-10-point increment; 95% CI, 0.84-0.97; =0.008), 3-month (HR [95% CI], 0.87 [0.82-0.93]; <0.001) and change in PAQ (HR [95% CI], 0.92 [0.85-0.99]; =0.021) were each associated with mortality. In fully adjusted models including combination of scores, 3-month PAQ was more strongly associated with mortality than either baseline (3-month HR [95% CI], 0.85 [0.78-0.92]; <0.001; C-statistic, 0.77) or change (3-month HR [95% CI], 0.79 [0.72-0.87]; <0.001). Conclusions PAD-specific health status is independently associated with 5-year survival in patients with new or worsening PAD symptoms, with the most recent assessment being most prognostic. Future work is needed to better understand how this information can be used proactively to optimize care.
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http://dx.doi.org/10.1161/JAHA.121.022232DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC9245831PMC
February 2022

Team-Based Care in Patients with Chronic Limb-Threatening Ischemia.

Curr Cardiol Rep 2022 Mar 7;24(3):217-223. Epub 2022 Feb 7.

Harrington Heart and Vascular Institute, University Hospitals and Case Western Reserve University School of Medicine, Cleveland, OH, USA.

Purpose Of Review: Team-based care has been proposed as a tool to improve health care delivery, especially for the treatment of complex medical conditions. Chronic limb-threatening ischemia (CLTI) is a complex disease associated with significant morbidity and mortality which often involves the care of multiple specialty providers. Coordination of efforts across the multiple physician specialists, nurses, wound care specialists, and administrators is essential to providing high-quality and efficient care. The aim of this review is to discuss the multiple facets of care of the CLTI patient and to describe components important for a team-based care approach.

Recent Findings: Observational studies have reported improved outcomes when using a team-based care approach in the care of the patients with CLTI, including reduction in mean wound healing times, decreasing rate of amputations, and readmissions. Team-based care can streamline care of CLTI patients by raising awareness, facilitating early recognition, and providing prompt vascular assessment, revascularization, and surveillance. This approach has the potential to improve patient outcomes and reduce downstream health care costs.
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http://dx.doi.org/10.1007/s11886-022-01643-2DOI Listing
March 2022

Impact of malnutrition and frailty on mortality and major amputation in patients with CLTI.

Catheter Cardiovasc Interv 2022 03 3;99(4):1300-1309. Epub 2022 Feb 3.

Department of Cardiovascular Medicine, Harrington Heart & Vascular Institute, University Hospitals, Cleveland, Ohio, USA.

Objectives: To understand the prevalence of malnutrition and its association with chronic limb-threatening ischemia (CLTI) outcomes; to clarify the differential impact of revascularization methods on outcomes; to assess the ability of the CLTI Frailty Risk Score (CLTI-FRS) to predict adverse events in patients hospitalized with CLTI.

Background: Despite advances in the management of CLTI, a majority still undergo major amputation, and a minority heal within 6 months. There is a lack of validated assessment tools for the identification and management of frailty and malnutrition in these patients.

Methods: Using the National Inpatient Sample from January 2012 to September 2015, we identified all patients with CLTI using International Classification of Diseases Ninth Edition Clinical Modification codes. The cohort was divided into three groups according to nutritional status. Multivariable regression analysis was used to analyze the interaction between malnutrition and outcomes of interest.

Results: Of 1,414,080 CLTI-related hospitalizations, 163,835 (11.6%) were malnourished, 332,855 (23.5%) patients were frail, 917,390 (64.9%) were well-nourished. In-hospital mortality, major amputation, the average length of stay, and hospital costs were highest among malnourished or frail patients and lowest in well-nourished patients (p < 0.001). Malnourished and frail patients were observed to have lower rates of mortality with endovascular revascularization as compared to surgical (adjusted odds ratios: 0.675 [0.533-0.854; p = 0.001]).

Conclusion: Many patients with CLTI are malnourished or frail, and this is associated with mortality and amputation. Both malnourished and frail patients were observed to have a mortality benefit with a less invasive approach to revascularization. Better assessment of nutritional and frailty status of CLTI patients may guide therapy and help prevent amputation and death.
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http://dx.doi.org/10.1002/ccd.30113DOI Listing
March 2022

Safety, Efficacy, and Cost-Effectiveness of Same-Day Discharge for Left Atrial Appendage Occlusion.

J Invasive Cardiol 2022 02;34(2):E124-E131

University Hospitals, Cleveland Medical Center, 11100 Euclid Avenue, Lakeside 3rd floor, Cleveland, OH, 44106 USA.

Background: Percutaneous left atrial appendage occlusion (LAAO) with the Watchman device is FDA approved for stroke prevention in patients with nonvalvular atrial fibrillation who have an appropriate indication. During the COVID-19 pandemic, a same-day discharge protocol (SDDP) was employed to improve resource utilization, relieve hospital occupation, and reduce the possible risk of in-hospital virus transmission.

Objectives: We sought to analyze the safety, feasibility, and cost effectiveness for SDDP in patients receiving LAAO.

Methods: A prospective analysis of 142 consecutive patients, 119 treated prior to SDDP and 23 who underwent SDDP following LAAO with cardiac computed tomography angiography (CTA)-guided pre-procedural planning and intracardiac echocardiogram (ICE). Procedures were performed in a single, large academic hospital in the United States. In-hospital and 45-day procedural success, adverse events, length of procedure, and length-of-stay were evaluated.

Results: Baseline patient characteristics including mean CHA2DS2VASc scores and mean HAS-BLED scores were similar in both groups. All procedures were successful. There was no significant difference in rates of procedural complications or in-hospital adverse events. The mean procedure time in the SDDP group was 11 minutes longer than in the conventional group (62.1 ± 5.9 vs 51.1 ± 21; P=.01). Outcomes at 45-day follow-up were similar. SDDP was associated with a reduced length of stay compared with conventional strategy and a 15% reduction in total costs.

Conclusions: Same-day discharge strategy for LAAO appears safe, feasible and could become the new standard approach for LAAO. A protocol including CTA pre-procedural planning, ICE-guided deployment and conscious sedation reduces hospital occupation and lowers costs.
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February 2022

Underutilization of Drug-Eluting Stents in Infrapopliteal Intervention for Chronic Limb-Threatening Ischemia.

J Endovasc Ther 2022 Jan 25:15266028211068763. Epub 2022 Jan 25.

Harrington Heart and Vascular Institute, Case Western Reserve University School of Medicine, University Hospitals Cleveland Medical Center, Case Western Reserve University, Cleveland, OH, USA.

Purpose: Multiple randomized clinical trials have shown superiority of drug-eluting stents (DES) over bare-metal stents (BMS) for infrapopliteal disease. However, real-world data on DES utilization and outcomes in infrapopliteal chronic limb-threatening ischemia (CLTI) patients are unknown.

Materials And Methods: We utilized the Nationwide Readmission Database (NRD) from 2016 to 2017 to extract patients undergoing infrapopliteal intervention with stents (BMS and DES) for CLTI using appropriate ICD-10 codes. Multilevel logistic regression with hospital ID as random effect was used to assess DES utilization. Primary outcome was the composite of target limb major amputation (TLmajA) and target limb revascularization (TLR). Multivariate Cox-proportional hazard regression was used to adjust for confounders.

Results: Our study included a total of 1817 patients. Of these patients, 1056 patients (58.1%) received DES; DES utilization was stable (relative change: +2.5%, p-trend: 0.867) between 2016 and 2017 and was higher in teaching hospitals (adjusted odds ratio [aOR] = 1.28, 95% CI = 1.03-1.61, p=0.029] and medium (aOR = 3.13, 95% CI = 2.17-4.55, p≤0.001) and large (aOR = 1.56, 95% CI = 1.14-2.17, p=0.005) bed-sized hospitals. Inter-class correlation was 0.44 suggesting ~44% variation in DES utilization between any 2 random hospitals; DES was associated with lower rate of the primary composite outcome (aHR = 0.75, 95% CI = 0.62-0.92, p=0.004) compared with BMS.

Conclusion: In patients undergoing infrapopliteal intervention for CLTI, DES demonstrated significant underutilization despite supportive evidence of their superiority compared with BMS; DES was associated with improvement in the primary composite outcome compared with BMS.
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http://dx.doi.org/10.1177/15266028211068763DOI Listing
January 2022

Impact of Interdisciplinary System-Wide Limb Salvage Advisory Council on Lower Extremity Major Amputation.

Circ Cardiovasc Interv 2022 01 21;15(1):e011306. Epub 2021 Dec 21.

Harrington Heart and Vascular Institute, University Hospitals and Case Western Reserve University School of Medicine, Cleveland, OH.

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http://dx.doi.org/10.1161/CIRCINTERVENTIONS.121.011306DOI Listing
January 2022

Acute Real-World Outcomes From the Phoenix Post-Approval Registry.

J Invasive Cardiol 2022 Jan 19;34(1):E1-E7. Epub 2021 Dec 19.

Professor of Medicine, Case Western Reserve University School of Medicine, University Hospitals, 11100 Euclid Avenue, Lakeside 3rd floor, Cleveland, OH 44106 USA.

Objectives: An evaluation of the 30-day safety and performance outcomes of the Phoenix atherectomy system (Philips Volcano Corporation) was performed in real-world patients with peripheral artery disease (PAD).

Methods: The Phoenix Post-Approval Registry is an all-comer study that enrolled patients with infrainguinal PAD. Patients treated with the Phoenix atherectomy system were followed for 30 days to observe device-related complications. Outcomes evaluated include procedural (final target lesion(s) residual stenosis of ≤30% after treatment with Phoenix and any other adjunctive therapy) and technical success (defined as achieving a post-Phoenix [prior to any adjunctive therapy] residual diameter stenosis of ≤50%), target-vessel revascularization (TVR), target-lesion revascularization (TLR), target-limb amputation, ankle brachial index, Rutherford clinical category, and wound, ischemia, foot infection (WIfI) classification.

Results: Of the 500 patients enrolled, 259 had CLI, including 26.3% with Rutherford class 6. Procedural success rates were 97.3% for non-CLI patients and 98.2% for CLI patients. Technical success rates were 71.5% for non-CLI patients and 77.9% for CLI patients. Complication rates post Phoenix atherectomy were <1%. Through the 30-day follow-up, there were 6 patients (1.3%; 2 claudicants, 4 CLIs) who underwent TLR and 8 patients who underwent TVR. There were no major amputations in the non-CLI and CLI cohorts. In the CLI cohort, 16/235 (6.8%) underwent minor amputations. Higher stages of Rutherford class and WIfI classification were associated with amputations at 30 days.

Conclusion: The Phoenix atherectomy system is a safe and effective treatment option in the acute setting for patients with PAD, including those with advanced Rutherford class. Randomized controlled trials are needed to confirm these results.
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January 2022

Association of Frailty With Treatment Selection and Long-Term Outcomes Among Patients With Chronic Limb-Threatening Ischemia.

J Am Heart Assoc 2021 12 16;10(24):e023138. Epub 2021 Dec 16.

Division of Cardiovascular Medicine Richard A. and Susan F. Smith Center for Outcomes Research in Cardiology Beth Israel Deaconess Medical Center Boston MA.

Background The optimal treatment strategy for patients with chronic limb-threatening ischemia (CLTI) is often unclear. Frailty has emerged as an important factor that can identify patients at greater risk of poor outcomes and guide treatment selection, but few studies have explored its utility among the CLTI population. We examine the association of a health record-based frailty measure with treatment choice and long-term outcomes among patients hospitalized with CLTI. Methods and Results We included patients aged >65 years hospitalized with CLTI in the Medicare Provider Analysis and Review data set between October 1, 2009 and September 30, 2015. The primary exposure was frailty, defined by the Claims-based Frailty Indicator. Baseline frailty status and revascularization choice were examined using logistic regression. Cox proportional hazards regression was used to determine the association between frailty and death or amputation, stratifying by treatment strategy. Of 85 060 patients, 35 484 (42%) were classified as frail. Frail patients had lower likelihood of revascularization (adjusted odds ratio [OR], 0.78; 95% CI, 0.75‒0.82). Among those revascularized, frailty was associated with lower likelihood of surgical versus endovascular treatment (adjusted OR, 0.76; CI, 0.72‒0.81). Frail patients experienced increased risk of amputation or death, regardless of revascularization status (revascularized: adjusted hazard ratio [HR], 1.34; CI, 1.30‒1.38; non-revascularized: adjusted HR, 1.22; CI, 1.17‒1.27). Among those revascularized, frailty was independently associated with amputation or death irrespective of revascularization strategy (surgical: adjusted HR, 1.36; CI, 1.31‒1.42; endovascular: aHR, 1.29; CI, 1.243‒1.35). Conclusions Among patients hospitalized with CLTI, frailty is an important independent predictor of revascularization strategy and longitudinal adverse outcomes.
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http://dx.doi.org/10.1161/JAHA.121.023138DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC9075246PMC
December 2021

Adverse Events With Intravascular Lithotripsy After Peripheral and Off-Label Coronary Use: A Report From the FDA MAUDE Database.

J Invasive Cardiol 2021 Dec;33(12):E974-E977

Minneapolis Heart Institute, 920 E. 28th Street #300, Minneapolis, MN 55407 USA.

Background: Currently only the peripheral intravascular lithotripsy (IVL) device is approved for use in the United States. We queried the United States Food and Drug Administration's Manufacturer and User Facility Device Experience (MAUDE) database from January 1, 2016 to December 14, 2020 for all reports of adverse events and modes of failure related to the peripheral IVL device, when used for on- and off-label indications. There were 20 reports of use in peripheral artery disease interventions and 3 reports of off-label use in coronary interventions. Device malfunction in 13 of 23 patients (56.5%) was the most common adverse event reported. Partial balloon or catheter dislodgment was the most common mode of IVL device failure in 12 of 20 patients (60%), followed by balloon rupture in 3 of 20 patients (15%). Coronary use was rare, and associated with balloon perforation in 1 of 3 patients, bradycardia in 1 of 3 patients, and aortocoronary dissection in 1 of 3 patients. In summary, IVL use carries risk of complications; hence, continued vigilance and postmarketing monitoring are warranted.
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December 2021

Novel intracardiac echocardiography-guided catheter-based removal of inoperable tricuspid valve vegetation.

Catheter Cardiovasc Interv 2022 02 12;99(2):508-511. Epub 2021 Nov 12.

University Hospitals Harrington Heart & Vascular Institute, Case Western Reserve University School of Medicine, Cleveland, Ohio, USA.

With the ongoing intravenous drug abuse (IVDA) epidemic, the number of IVDA patients with infective endocarditis is increasing. These cases are often characterized by large vegetations complicated by valvular dysfunction, heart failure, and recurrent septic pulmonary emboli demanding surgical intervention. Latter cannot be offered in a good proportion of the patients due to challenging medical and social complexities. Hence, AngioVac system has been used as an alternative therapy; however, it is associated with high procedural mortality. In this document, we describe in detail the successful treatment of a case of large tricuspid valve vegetation, with prohibitive risk for surgery, using a percutaneous catheter-based system, the Triever aspiration catheter with FLEX technology, with the guidance of intracardiac echocardiogram.
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http://dx.doi.org/10.1002/ccd.29999DOI Listing
February 2022

Differences Between Patients With Intermittent Claudication and Critical Limb Ischemia Undergoing Endovascular Intervention: Insights From the Excellence in Peripheral Artery Disease Registry.

Circ Cardiovasc Interv 2021 11 27;14(11):e010635. Epub 2021 Oct 27.

University of Texas Southwestern Medical Center, Dallas (K.P., Y.L., M.A.A., N.M., I.T., S.B.).

Background: There are limited data on differences in angiographic distribution of peripheral artery disease and endovascular revascularization strategies in patients presenting with intermittent claudication (IC) and critical limb ischemia (CLI). We aimed to compare anatomic features, treatment strategies, and clinical outcomes between patients with IC and CLI undergoing endovascular revascularization.

Methods: We examined 3326 patients enrolled in the Excellence in Peripheral Artery Disease registry from 2006 to 2019 who were referred for endovascular intervention for IC (n=1983) or CLI (n=1343). The primary outcome was 1-year major adverse limb events, which included death, repeat target limb revascularization, or target limb amputation.

Results: Patients with CLI were older and more likely to have diabetes and chronic kidney disease and less likely to receive optimal medical therapy compared with IC. Patients with IC had higher femoropopliteal artery interventions (IC 87% versus CLI 65%; <0.001), while below the knee interventions were more frequent in CLI (CLI 47% versus IC 12%; <0.001). Patients with CLI were more likely to have multilevel peripheral artery disease (CLI 32% versus IC 15%, <0.001). Patients with IC were predominantly revascularized with stents (IC 48% versus CLI 37%; <0.001) while balloon angioplasty was more frequent in CLI (CLI 37% versus IC 25%; <0.001). All-cause mortality was higher in patients with CLI (CLI 4% versus IC 2%; =0.014). Major adverse limb event rates for patients with IC and CLI were 16% and 26%, respectively (<0.001) and remained higher in CLI after multivariable adjustment of baseline risk factors.

Conclusions: Patients with IC and CLI have significant anatomic, lesion, and treatment differences with significantly higher mortality and adverse limb outcomes in CLI. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01904851. Graphic Abstract: A graphic abstract is available for this article.
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http://dx.doi.org/10.1161/CIRCINTERVENTIONS.121.010635DOI Listing
November 2021

Left Atrial Appendage Occlusion Using Cardiac CT Angiography and Intracardiac Echocardiography: A Prospective, Single-Center Study.

J Invasive Cardiol 2021 Nov 7;33(11):E851-E856. Epub 2021 Oct 7.

University Hospitals, Cleveland Medical Center, 11100 Euclid Avenue, Lakeside 3rd floor, Cleveland, OH 44106 USA.

Objectives: We reviewed the periprocedural events, accuracy of device selection, and outcomes of a series of patients receiving percutaneous left atrial appendage occlusion (LAAO) with cardiac computed tomography angiography (CTA)-guided preprocedural planning and intracardiac echocardiography (ICE)-guided device deployment.

Background: Percutaneous LAAO with the Watchman device (Boston Scientific) is approved by the United States Food and Drug Administration for stroke prevention in patients with non-valvular atrial fibrillation with a demonstrated contraindication to oral anticoagulation. Cardiac CTA preprocedural planning with utilization of an ICE-guided deployment may be associated with favorable outcomes.

Methods: A prospective analysis of 71 non-consecutive patients who underwent LAAO over an 18-month period with cardiac CTA-guided preprocedural planning and ICE was conducted. Procedures were performed in a single large, academic hospital in the United States. Procedural success, correlation of CTA preprocedural device sizing with final device size utilization, adverse events, length of procedure, and length of stay were evaluated.

Results: Preprocedural cardiac CTA-guided device sizing was consistent with the final deployed device in 69 patients (97.2%) evaluated in this case series. Procedure success rate was 100%. All implants were performed using Watchman devices, 45 (63.4%) with the original 2.5 platform and 26 (36.6%) with the Watchman FLX platform. All patients were treated with conscious sedation and the mean length of stay was 1.45 ± 0.72 days. Only 2 adverse events occurred and both resolved.

Conclusions: Cardiac CTA-guided preprocedural planning resulted in accurate device sizing in this patient sample and may be used in conjunction with ICE and conscious sedation for a same-day discharge strategy in select patients.
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November 2021

Paclitaxel-coated balloons versus percutaneous transluminal angioplasty for infrapopliteal chronic total occlusions: the IN.PACT BTK randomised trial.

EuroIntervention 2022 Apr 1;17(17):e1445-e1454. Epub 2022 Apr 1.

Cardiology, University of Messina, Messina, Italy.

Background: Data are mixed concerning the safety and effectiveness of drug-coated balloons (DCBs) for treating below-the-knee (BTK) lesions.

Aims: The aim of this study was to assess the safety and effectiveness of the IN.PACT 014 paclitaxel-coated balloon catheter versus conventional percutaneous transluminal angioplasty (PTA) for infrapopliteal chronic total occlusions (CTOs) in patients with chronic limb-threatening ischaemia (CLTI).

Methods: The IN.PACT BTK randomised study is a prospective, multicentre, randomised pilot study. Fifty CLTI participants (Rutherford clinical category 4-5) with BTK CTOs were randomised 1:1 to DCB (N=23) or PTA (N=27). The primary effectiveness endpoint was late lumen loss (LLL) at 9 months post procedure. Safety outcomes up to 9 months included all-cause mortality, major target limb amputation, and clinically driven target lesion revascularisation (CD-TLR).

Results: Mean lesion length was 215.41±83.81 mm in the DCB group and 218.19±80.43 mm for PTA (p=0.806). The 9-month angiographic LLL was 0.892±0.774 mm for the DCB group and 1.312±0.720 mm for the PTA group (p=0.070) in a classic analysis, and 0.592±0.944 mm for DCB and 1.260±0.810 mm for PTA (p=0.017) in a subsegmental analysis. The Kaplan-Meier estimated freedom from CD-TLR up to 9 months was 91.1% for DCB and 91.8% for PTA (log-rank p=0.942). At 9 months, 1 patient died in the DCB group and 2 in the PTA group (p=1.000); there were no major target limb amputations in either arm.

Conclusions: The 9-month subsegmental LLL was lower after treatment with the IN.PACT 014 DCB compared with PTA with no differences in safety or revascularisation events in a small complex population of patients with BTK CTOs.

Clinicaltrials: gov: NCT02963649.
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http://dx.doi.org/10.4244/EIJ-D-21-00444DOI Listing
April 2022

The utility of geriatric nutritional risk index to predict outcomes in chronic limb-threatening ischemia.

Catheter Cardiovasc Interv 2022 01 19;99(1):121-133. Epub 2021 Sep 19.

Harrington Heart and Vascular Institute, University Hospitals Cleveland Medical Center, Cleveland, Ohio, USA.

Objectives: To assess geriatric nutritional risk index (GNRI) in patients with chronic limb-threatening ischemia (CLTI).

Background: The prevalence of CLTI continues to rise, with major amputation and mortality remaining prominent. Frailty is a vital risk factor for adverse outcomes in cardiovascular care. The GNRI is a nutrition-based surrogate for frailty that has been utilized in Southeast Asia to predict adverse events in CLTI. It has not yet been evaluated in a primarily Western population, nor in the context of wound healing.

Methods: Between 8August 2017 and April 2019, we identified patients undergoing endovascular interventions for CLTI at our institution, categorized into low GNRI (≤ 94, frail) versus normal GNRI (> 94, reference). We analyzed the risks of major adverse limb events (MALE), its individual components [mortality, major amputation, and target vessel revascularization (TVR)], amputation free survival (AFS), and wound healing using Kaplan-Meier and multivariate cox-proportional hazard regression analyses.

Results: A total of 255 patients were included in the analysis, with follow up of 14 ± 9.1 months. Lower GNRI was associated with higher cumulative event rates for MALE (71.0% vs. 43.3%, p <  0.001), mortality (34.3% vs. 15.2%, p < 0.001), major amputation (31.2% vs. 15.8%, p = 0.002), and freedom from AFS (56.0% vs. 28.2%, p < 0.001). There was a trend toward lower TVR and higher wound healing with higher GNRI score.

Conclusions: Our single-center, retrospective evaluation of GNRI (as a surrogate for frailty) correlated with increased risks of MALE, mortality, and major amputation. Future directions should focus not only on the recognition of these patients, but risk-factor modification to optimize long-term outcomes.
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http://dx.doi.org/10.1002/ccd.29949DOI Listing
January 2022

Sex Differences in Trends and In-Hospital Outcomes Among Patients With Critical Limb Ischemia: A Nationwide Analysis.

J Am Heart Assoc 2021 09 17;10(18):e022043. Epub 2021 Sep 17.

Department of Medicine Weill Cornell Medicine-Qatar Doha Qatar.

Background Critical limb ischemia (CLI) represents the most severe form of peripheral artery disease and is associated with significant mortality and morbidity. Contemporary data comparing the sex differences in trends, revascularization strategies, and in-hospital outcomes among patients with CLI are scarce. Methods and Results Using the National Inpatient Sample database years 2002 to 2015, we identified hospitalizations for CLI. Temporal trends for hospitalizations for CLI were evaluated. The differences in demographics, revascularization, and in-hospital outcomes between both sexes were compared. Among 2 400 778 CLI hospitalizations, 43.6% were women. Women were older and had a higher prevalence of obesity, hypertension, heart failure, and prior stroke. Women were also less likely to receive any revascularization (34.7% versus 35.4%, <0.001), but the trends of revascularization have been increasing among both sexes. Revascularization was associated with lower in-hospital mortality among women (adjusted odds ratio [OR], 0.76; 95% CI, 0.71-0.81) and men (adjusted OR, 0.69; 95% CI, 0.65-0.73). On multivariable analysis adjusting for patient- and hospital-related characteristics as well as revascularization, women had a higher incidence of in-hospital mortality, postoperative hemorrhage, need for blood transfusion, postoperative infection, ischemic stroke, and discharge to facilities compared with men. Conclusions In this nationwide contemporary analysis of CLI hospitalizations, women were older and less likely to undergo revascularization. Women had a higher incidence of in-hospital mortality and bleeding complications compared with men. Sex-specific studies and interventions are needed to minimize these gaps among this high-risk population.
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http://dx.doi.org/10.1161/JAHA.121.022043DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8649496PMC
September 2021
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