Publications by authors named "Roger Laham"

92 Publications

Heterotopic caval valve implantation for the management of severe tricuspid regurgitation: a case series.

Eur Heart J Case Rep 2021 Jan 28;5(1):ytaa428. Epub 2020 Dec 28.

Department of Anesthesia, Critical Care and Pain Medicine. Beth Israel Deaconess Medical Center, Harvard Medical School, One, Deaconess Road, Boston, MA 02215, USA.

Background: Severe tricuspid regurgitation (TR) is a complex condition that can be difficult to treat medically, and often surgical intervention is prohibited due to the high morbidity and mortality associated with this intervention. In patients who have failed maximal medical therapy and have progressive symptoms related to their severe TR, heterotopic caval valve implantation (CAVI) offers potential for symptom relief for these patients.

Case Summary: We present two cases of patients with severe TR with symptoms of heart failure that were refractory to medical therapy. Due to extensive comorbidities in these patient's surgical intervention was deemed unsuitable and the decision was made to proceed with heterotopic CAVI in order to try and control their symptoms. Both patients successfully underwent the procedure and had an Edwards SAPIEN 3 valve (Edwards Lifesciences, Irvine, CA, USA) implanted in the inferior vena cava/right atrium junction. In both patients, there was improvement in the postoperative haemodynamics as measured by invasive and non-invasive methods. Successful discharge was achieved in both patients with improvement in their symptoms.

Discussion: Selective use of heterotopic CAVI to treat symptomatic severe TR that is refractory to medical therapy may be a viable option to improve symptoms in those patients that are unsuitable for surgical intervention.
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http://dx.doi.org/10.1093/ehjcr/ytaa428DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7898562PMC
January 2021

CoreValve bioprosthesis dysfunction treated with a Sapien 3 valve-in-valve transcatheter aortic valve replacement and BASILICA technique.

Catheter Cardiovasc Interv 2021 Feb 17. Epub 2021 Feb 17.

Cardiovascular Institute, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts, USA.

Structural deterioration of transcatheter heart valve (THV) has been previously described. With the expansion of transcatheter aortic valve replacement (TAVR) indications toward treating lower risk patients with longer life expectancy, there will be increased necessity of managing the patients with THV dysfunction including those at risk for coronary obstruction or sinus sequestration. Coronary access also remains a challenge in such cases with THV dysfunction undergoing valve-in-transcatheter heart valve (ViTHV) TAVR. A unique and first reported case of THV deterioration treated with Sapien 3 ViTHV-TAVR inside a 31 mm CoreValve bioprosthesis along with left coronary leaflet laceration using the BASILICA technique has been presented.
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http://dx.doi.org/10.1002/ccd.29544DOI Listing
February 2021

Physical Performance and Risk of Postoperative Delirium in Older Adults Undergoing Aortic Valve Replacement.

Clin Interv Aging 2020 24;15:1471-1479. Epub 2020 Aug 24.

Division of Gerontology, Department of Medicine, Beth Israel Deaconess Medical Center, Boston, MA, USA.

Background: Delirium is a major risk factor for poor recovery after surgical aortic valve replacement (SAVR) and transcatheter aortic valve replacement (TAVR). It is unclear whether preoperative physical performance tests improve delirium prediction.

Objective: To examine whether physical performance tests can predict delirium after SAVR and TAVR, and adapt an existing delirium prediction rule for cardiac surgery, which includes Mini-Mental State Examination (MMSE), depression, prior stroke, and albumin level.

Design: Prospective cohort, 2014-2017.

Setting: Single academic center.

Subjects: A total of 187 patients undergoing SAVR (n=77) or TAVR (n=110).

Methods: The Short Physical Performance Battery (SPPB) score was calculated based on gait speed, balance, and chair stands (range: 0-12 points, lower scores indicate poor performance). Delirium was assessed using the Confusion Assessment Method. We fitted logistic regression to predict delirium using SPPB components and risk factors of delirium.

Results: Delirium occurred in 35.8% (50.7% in SAVR and 25.5% in TAVR). The risk of delirium increased for lower SPPB scores: 10-12 (28.2%), 7-9 (34.5%), 4-6 (37.5%) and 0-3 (44.1%) (p-for-trend=0.001). A model that included gait speed <0.46 meter/second (OR, 2.7; 95% CI, 1.2-6.4), chair stands time ≥11.2 seconds (OR, 3.5; 95% CI, 1.0-12.4), MMSE <24 points (OR, 2.9; 95% CI, 1.3-6.4), isolated SAVR (OR, 5.4; 95% CI, 2.1-13.8), and SAVR and coronary artery bypass grafting (OR, 15.8; 95% CI, 5.5-45.7) predicted delirium better than the existing prediction rule (C statistics: 0.71 vs 0.61; p=0.035).

Conclusion: Assessing physical performance, in addition to cognitive function, can help identify high-risk patients for delirium after SAVR and TAVR.
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http://dx.doi.org/10.2147/CIA.S257079DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7455771PMC
December 2020

Cognition, Frailty, and Functional Outcomes of Transcatheter Aortic Valve Replacement.

Am J Med 2020 10 19;133(10):1219-1222. Epub 2020 Mar 19.

Division of Gerontology, Beth Israel Deaconess Medical Center, Boston, Mass; Marcus Institute for Aging Research, Hebrew SeniorLife, Boston, Mass. Electronic address:

Background: Cognitive impairment and frailty are highly prevalent in older adults undergoing transcatheter aortic valve replacement. This study aimed to investigate the relationship of cognitive impairment and frailty with functional recovery after transcatheter aortic valve replacement.

Methods: This was a single-center prospective cohort study of 142 patients who were ≥70 years old and underwent transcatheter aortic valve replacement for aortic stenosis. Prior to transcatheter aortic valve replacement, cognitive impairment was defined as Mini-Mental State Examination score <24 points (range: 0-30), and moderate-to-severe frailty was defined as a deficit-accumulation frailty index ≥0.35 (range: 0-1). The functional status composite score, the number of 22 daily and physical tasks that a patient could perform independently, measured at baseline and 1, 3, 6, 9, and 12 months postoperatively were analyzed using linear mixed-effects model.

Results: The mean age was 84.2 years; 74 subjects were women (51.8%). Patients with moderate-to-severe frailty and cognitive impairment (n = 27, 19.0%) had the lowest functional status at baseline and throughout 12 months, while patients with mild or no frailty and no cognitive impairment (n = 48, 33.8%) had the best functional status. Patients with cognitive impairment alone (n = 19, 13.4%) had better functional status at baseline than those with moderate-to-severe frailty alone (n = 48, 33.8%), but their functional status scores merged and remained similar during the follow-up.

Conclusions: Preoperative cognitive function plays a vital role in functional recovery after transcatheter aortic valve replacement, regardless of baseline frailty status. Impaired cognition may increase functional decline in the absence of frailty, whereas intact cognition may mitigate the detrimental effects of frailty. Cognitive assessment should be routinely performed prior to transcatheter aortic valve replacement.
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http://dx.doi.org/10.1016/j.amjmed.2020.01.041DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7501150PMC
October 2020

Comparative utility of frailty to a general prognostic score in identifying patients at risk for poor outcomes after aortic valve replacement.

BMC Geriatr 2020 02 3;20(1):38. Epub 2020 Feb 3.

Hinda and Arthur Marcus Institute for Aging Research, Hebrew Senior Life, Harvard Medical School, Boston, MA, USA.

Background: Current guidelines recommend considering life expectancy before aortic valve replacement (AVR). We compared the performance of a general mortality index, the Lee index, to a frailty index.

Methods: We conducted a prospective cohort study of 246 older adults undergoing surgical (SAVR) or transcatheter aortic valve replacement (TAVR) at a single academic medical center. We compared performance of the Lee index to a deficit accumulation frailty index (FI). Logistic regression was used to assess the association of Lee index or FI with poor outcome, defined as death or functional decline with severe symptoms at 12 months. Discrimination was assessed using C-statistics.

Results: In the overall cohort, 44 experienced poor outcome (31 deaths, 13 functional decline with severe symptoms). The risk of poor outcome by Lee index quartiles was 6.8% (reference), 17.9% (odds ratio [OR], 3.0; 95% confidence interval, [0.9-10.2]), 20.0% (OR 3.4; [1.0-11.4]), and 34.0% (OR 7.1; [2.2-22.6]) (p-for-trend = 0.001). Risk of poor outcome by FI quartiles was 3.6% (reference), 10.3% (OR 3.1; [0.6-15.8]), 25.0% (OR 8.8; [1.9-41.0]), and 37.3% (OR 15.8; [3.5-71.1]) (p-for-trend< 0.001). The Lee index predicted the risk of poor outcome in the SAVR cohort Lee index (quartiles 1-4: 2.1, 4.0, 15.4, and 20.0%; p-for-trend = 0.04), but not in the TAVR cohort (quartiles 1-4: 27.3, 29.0, 21.3, 35.4%; p-for-trend = 0.42). In contrast, the FI did not predict the risk of poor outcome well in the SAVR cohort (quartiles 1-4: 2.3, 4.4, 15.8, and 0%; p-for-trend = 0.24), however in the TAVR cohort (quartiles 1-4: 9.1, 14.3, 29.7, and 40.7%; p-for-trend = 0.004). Compared to the Lee index, an FI demonstrated higher C-statistics in the overall (Lee index versus FI: 0.680 versus 0.735; p = 0.03) and TAVR (0.560 versus 0.644; p = 0.03) cohorts, but not SAVR cohort (0.724 versus 0.766; p = 0.09).

Conclusions: While a general mortality index Lee index predicted death or functional decline with severe symptoms at 12 months well among SAVR patients, the FI derived from a multi-domain geriatric assessment better informs risk-stratification for high-risk TAVR patients.
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http://dx.doi.org/10.1186/s12877-020-1440-4DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6998298PMC
February 2020

Long-term clinical safety and efficacy of drug-coated balloon in the treatment of in-stent restenosis: A meta-analysis and systematic review.

Catheter Cardiovasc Interv 2020 08 12;96(2):E129-E141. Epub 2019 Nov 12.

Department of Cardiology, The Dongguan Affiliated Hospital (Dongguan 5th People's Hospital), Jinan University School of Medicine, Dongguan, China.

Objectives: The aim of this study was to evaluate the long-term clinical safety and efficacy of drug-coated balloon (DCB) in the treatment of in-stent restenosis (ISR).

Background: There is a long-term safety issue in peripheral arterial disease patients treated with paclitaxel-coated balloon, this has also raised concerns on DCB in coronary intervention.

Methods: Nine randomized controlled trials (RCTs) and nine observational studies (OSs) were included with a total of 3,782 patients (1,827 in the DCB group, 1,955 in the drug-eluting stent [DES] group) being analyzed. The primary outcome measure-major adverse cardiovascular events (MACEs), target lesion revascularization (TLR), target vessel revascularization (TVR), myocardial infarction (MI), cardiac death (CD), stent thrombosis (ST), all-cause death (AD), and coronary angiography outcomes included late lumen loss (LLL), minimum luminal diameter (MLD), diameter stenosis (DS) were analyzed.

Results: DCB treatment significantly reduced the LLL (MD: -0.13; [CI -0.23 to -0.03], p = .01). No difference was found for MLD (MD: -0.1; [CI -0.24 to 0.04], p = .17) and DS% (RR = 0.98 [CI 0.80-1.20], p = .86). There was no significant difference in TLR, TVR, MI, CD, ST, AD, and the overall incidence of MACEs between the two groups up to 3 years follow-up. Subgroup analysis for different type of ISR and DES showed no significant difference in the incidence of endpoints, and there is no difference when considering RCTs or OSs only.

Conclusions: The safety and efficacy of the DCB and DES in the treatment of ISR is comparable at up to 3 years follow-up.
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http://dx.doi.org/10.1002/ccd.28572DOI Listing
August 2020

A 3-Dimensionally Printed, High-Fidelity Ultrasound-Guided Pericardiocentesis Training Model.

J Cardiothorac Vasc Anesth 2020 Jan 5;34(1):245-247. Epub 2019 Sep 5.

Department of Anesthesia, Critical Care and Pain Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA.

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http://dx.doi.org/10.1053/j.jvca.2019.08.051DOI Listing
January 2020

Percutaneous Balloon Pericardiotomy and Indwelling Pericardial-Pleural Drain Placement for Refractory Malignant Pericardial Effusion.

J Vasc Interv Radiol 2019 Aug;30(8):1208-1209

Division of Interventional Radiology, Department of Radiology, Beth Israel Deaconess Medical Center/Harvard Medical School, Boston, Massachusetts.

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http://dx.doi.org/10.1016/j.jvir.2018.12.012DOI Listing
August 2019

A Practical Two-Stage Frailty Assessment for Older Adults Undergoing Aortic Valve Replacement.

J Am Geriatr Soc 2019 10 18;67(10):2031-2037. Epub 2019 Jun 18.

Division of Gerontology, Beth Israel Deaconess Medical Center, Boston, Massachusetts.

Objectives: Despite evidence, frailty is not routinely assessed before cardiac surgery. We compared five brief frailty tests for predicting poor outcomes after aortic valve replacement and evaluated a strategy of performing comprehensive geriatric assessment (CGA) in screen-positive patients.

Design: Prospective cohort study.

Setting: A single academic center.

Participants: Patients undergoing surgical aortic valve replacement (SAVR) (n = 91; mean age = 77.8 y) or transcatheter aortic valve replacement (TAVR) (n = 137; mean age = 84.5 y) from February 2014 to June 2017.

Measurements: Brief frailty tests (Fatigue, Resistance, Ambulation, Illness, and Loss of weight [FRAIL] scale; Clinical Frailty Scale; grip strength; gait speed; and chair rise) and a deficit-accumulation frailty index based on CGA (CGA-FI) were measured at baseline. A composite of death or functional decline and severe symptoms at 6 months was assessed.

Results: The outcome occurred in 8.8% (n = 8) after SAVR and 24.8% (n = 34) after TAVR. The chair rise test showed the highest discrimination in the SAVR (C statistic = .76) and TAVR cohorts (C statistic = .63). When the chair rise test was chosen as a screening test (≥17 s for SAVR and ≥23 s for TAVR), the incidence of outcome for screen-negative patients, screen-positive patients with CGA-FI of .34 or lower, and screen-positive patients with CGA-FI higher than .34 were 1.9% (n = 1/54), 5.3% (n = 1/19), and 33.3% (n = 6/18) after SAVR, respectively, and 15.0% (n = 9/60), 14.3% (n = 3/21), and 38.3% (n = 22/56) after TAVR, respectively. Compared with routinely performing CGA, targeting CGA to screen-positive patients would result in 54 fewer CGAs, without compromising sensitivity (routine vs targeted: .75 vs .75; P = 1.00) and specificity (.84 vs .86; P = 1.00) in the SAVR cohort; and 60 fewer CGAs with lower sensitivity (.82 vs.65; P = .03) and higher specificity (.50 vs .67; P < .01) in the TAVR cohort.

Conclusions: The chair rise test with targeted CGA may be a practical strategy to identify older patients at high risk for mortality and poor recovery after SAVR and TAVR in whom individualized care management should be considered. J Am Geriatr Soc 67:2031-2037, 2019.
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http://dx.doi.org/10.1111/jgs.16036DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6800747PMC
October 2019

Diagnosis of obstructive coronary artery disease using computed tomography angiography in patients with stable chest pain depending on clinical probability and in clinically important subgroups: meta-analysis of individual patient data.

BMJ 2019 06 12;365:l1945. Epub 2019 Jun 12.

Department of Radiology, Charité - Universitätsmedizin Berlin, Charitéplatz 1, 10117 Berlin, Germany

Objective: To determine whether coronary computed tomography angiography (CTA) should be performed in patients with any clinical probability of coronary artery disease (CAD), and whether the diagnostic performance differs between subgroups of patients.

Design: Prospectively designed meta-analysis of individual patient data from prospective diagnostic accuracy studies.

Data Sources: Medline, Embase, and Web of Science for published studies. Unpublished studies were identified via direct contact with participating investigators.

Eligibility Criteria For Selecting Studies: Prospective diagnostic accuracy studies that compared coronary CTA with coronary angiography as the reference standard, using at least a 50% diameter reduction as a cutoff value for obstructive CAD. All patients needed to have a clinical indication for coronary angiography due to suspected CAD, and both tests had to be performed in all patients. Results had to be provided using 2×2 or 3×2 cross tabulations for the comparison of CTA with coronary angiography. Primary outcomes were the positive and negative predictive values of CTA as a function of clinical pretest probability of obstructive CAD, analysed by a generalised linear mixed model; calculations were performed including and excluding non-diagnostic CTA results. The no-treat/treat threshold model was used to determine the range of appropriate pretest probabilities for CTA. The threshold model was based on obtained post-test probabilities of less than 15% in case of negative CTA and above 50% in case of positive CTA. Sex, angina pectoris type, age, and number of computed tomography detector rows were used as clinical variables to analyse the diagnostic performance in relevant subgroups.

Results: Individual patient data from 5332 patients from 65 prospective diagnostic accuracy studies were retrieved. For a pretest probability range of 7-67%, the treat threshold of more than 50% and the no-treat threshold of less than 15% post-test probability were obtained using CTA. At a pretest probability of 7%, the positive predictive value of CTA was 50.9% (95% confidence interval 43.3% to 57.7%) and the negative predictive value of CTA was 97.8% (96.4% to 98.7%); corresponding values at a pretest probability of 67% were 82.7% (78.3% to 86.2%) and 85.0% (80.2% to 88.9%), respectively. The overall sensitivity of CTA was 95.2% (92.6% to 96.9%) and the specificity was 79.2% (74.9% to 82.9%). CTA using more than 64 detector rows was associated with a higher empirical sensitivity than CTA using up to 64 rows (93.4% 86.5%, P=0.002) and specificity (84.4% 72.6%, P<0.001). The area under the receiver-operating-characteristic curve for CTA was 0.897 (0.889 to 0.906), and the diagnostic performance of CTA was slightly lower in women than in with men (area under the curve 0.874 (0.858 to 0.890) 0.907 (0.897 to 0.916), P<0.001). The diagnostic performance of CTA was slightly lower in patients older than 75 (0.864 (0.834 to 0.894), P=0.018 all other age groups) and was not significantly influenced by angina pectoris type (typical angina 0.895 (0.873 to 0.917), atypical angina 0.898 (0.884 to 0.913), non-anginal chest pain 0.884 (0.870 to 0.899), other chest discomfort 0.915 (0.897 to 0.934)).

Conclusions: In a no-treat/treat threshold model, the diagnosis of obstructive CAD using coronary CTA in patients with stable chest pain was most accurate when the clinical pretest probability was between 7% and 67%. Performance of CTA was not influenced by the angina pectoris type and was slightly higher in men and lower in older patients.

Systematic Review Registration: PROSPERO CRD42012002780.
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http://dx.doi.org/10.1136/bmj.l1945DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6561308PMC
June 2019

Delirium Incidence and Functional Outcomes After Transcatheter and Surgical Aortic Valve Replacement.

J Am Geriatr Soc 2019 07 18;67(7):1393-1401. Epub 2019 Mar 18.

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

Background: Transcatheter aortic valve replacement (TAVR) may be associated with less delirium and allow faster recovery than surgical aortic valve replacement (SAVR).

Objective: To examine the association of delirium and its severity with clinical and functional outcomes after SAVR and TAVR.

Design: Prospective cohort study.

Setting: An academic medical center.

Participants: A total of 187 patients, aged 70 years and older, undergoing SAVR (N = 77) and TAVR (N = 110) in 2014 to 2016.

Measurements: Delirium was assessed daily using the Confusion Assessment Method (CAM), with severity measured by the CAM-Severity (CAM-S) score (range = 0-19). Outcomes were prolonged hospitalization (9 days or more); institutional discharge; and functional status, measured by ability to perform 22 daily activities and physical tasks over 12 months.

Results: SAVR patients had a higher incidence of delirium than TAVR patients (50.7% vs 25.5%; P < .001), despite younger mean age (77.9 vs 83.7 years) and higher baseline Mini-Mental State Examination score (26.9 vs 24.7). SAVR patients with delirium had a shorter duration (2.2 vs 3.4 days; P = .04) with a lower mean CAM-S score (4.5 vs 5.7; P = .01) than TAVR patients with delirium. The risk of prolonged hospitalization in no, mild, and severe delirium was 18.4%, 30.8%, and 61.5% after SAVR (P for trend = .009) and 26.8%, 38.5%, and 73.3% after TAVR (P for trend = .001), respectively. The risk of institutional discharge was 42.1%, 58.3%, and 84.6% after SAVR (P for trend = .01) and 32.5%, 69.2%, and 80.0% after TAVR (P for trend <.001), respectively. Severe delirium was associated with delayed functional recovery after SAVR and persistent functional impairment after TAVR at 12 months.

Conclusion: Less invasive TAVR was associated with lower incidence of delirium than SAVR. Once delirium developed, TAVR patients had more severe delirium and worse functional status trajectory than SAVR patients did.

Registration: NCT01845207.
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http://dx.doi.org/10.1111/jgs.15867DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6612597PMC
July 2019

Contemporary Discrepancies of Stenosis Assessment by Computed Tomography and Invasive Coronary Angiography.

Circ Cardiovasc Imaging 2019 02;12(2):e007720

Division of Cardiology, Johns Hopkins University School of Medicine, Baltimore, MD (Y.B.S., A.A.-Z., M.R.O., A.L.V., J.B., J.A.C.L., J.M.M.).

Background Ongoing advancements of coronary computed tomographic angiography (CTA) continue to challenge the role of invasive coronary angiography (ICA) as the gold standard for the evaluation of coronary artery disease (CAD). We sought to investigate the diagnostic accuracy of 320-slice CTA for detecting obstructive CAD in reference to ICA and nuclear myocardial perfusion imaging using single-photon emission computed tomography. Methods For the CORE320 study (Coronary Artery Evaluation Using 320-Row Multidetector Computed Tomography Angiography and Myocardial Perfusion), 381 patients at 16 centers underwent CTA, nuclear myocardial perfusion imaging by single-photon emission computed tomography, and ICA for the evaluation of CAD. Imaging studies were analyzed in blinded core laboratories, and a stenosis of ≥50% by quantitative coronary angiography was considered obstructive, whereas a stress difference score of ≥1 indicated inducible myocardial ischemia. The area under the receiver operating characteristic curve was used to evaluate diagnostic accuracy. Results Of 381 patients, 229 (60%) had obstructive CAD by quantitative coronary angiography. Diagnostic accuracy of CTA on a per-patient analysis revealed an area under the receiver operating characteristic curve of 0.90 (95% CI, 0.87-0.93). Per-vessel and per-segment analysis revealed lower area under the receiver operating characteristic curve of 0.87 (0.84-0.90) and 0.81 (0.78-0.83), respectively. Median radiation dose was lower for CTA versus ICA: 3.16 (interquartile range, 2.82-3.59) versus 11.97 (interquartile range, 7.60-17.8) mSv ( P<0.001). Accuracy for identifying patients with inducible myocardial ischemia by SPECT-MPI was similar for CTA and ICA (area under the receiver operating characteristic curve, 0.68 versus 0.71 by quantitative coronary angiography and 0.68 by visual angiographic assessment; P>0.05). Furthermore, accuracy for identifying patients who subsequently underwent clinically driven coronary revascularization also was similar for CTA (0.76 [0.71-0.81]) and ICA (0.78 [0.74-0.83]; P=0.20). Conclusions Contemporary CTA accurately identifies patients with obstructive CAD by ICA at lower radiation exposure; however, agreement is lower in vessel- and segment-level analyses. Both CTA and ICA perform similarly for predicting clinically driven revascularization and for detecting myocardial ischemia by myocardial perfusion imaging using single-photon emission computed tomography, suggesting that limitations by both CTA and ICA contribute to variability of stenosis quantification. Clinical Trial Registration URL: https://www.clinicaltrials.gov . Unique identifier: NCT00934037.
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http://dx.doi.org/10.1161/CIRCIMAGING.118.007720DOI Listing
February 2019

Evaluation of Changes in Functional Status in the Year After Aortic Valve Replacement.

JAMA Intern Med 2019 03;179(3):383-391

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

Importance: Functional status is a patient-centered outcome that is important for a meaningful gain in health-related quality of life after aortic valve replacement.

Objective: To determine functional status trajectories in the year after transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR).

Design, Setting, And Participants: A prospective cohort study with a 12-month follow-up was conducted at a single academic center in 246 patients undergoing TAVR or SAVR for severe aortic stenosis. The study was conducted between February 1, 2014, and June 30, 2017; data analysis was performed from December 27, 2017, to May 7, 2018.

Exposures: Preoperative comprehensive geriatric assessment was performed and a deficit-accumulation frailty index (CGA-FI) (range, 0-1; higher values indicate greater frailty) was calculated.

Main Outcomes And Measures: Telephone interviews were conducted to assess self-reported ability to perform 22 activities and physical tasks at 1, 3, 6, 9, and 12 months after the procedure.

Results: Of the 246 patients included in the study, 143 underwent TAVR (74 [51.7%] women; mean [SD] age, 84.2 [5.9] years), and 103 underwent SAVR (46 [44.7%] women; age, 78.1 [5.3] years). Five trajectories were identified based on functional status at baseline and during the follow-up: from excellent at baseline to improvement at follow-up (excellent baseline-improvement), good (high baseline-full recovery), fair (moderate baseline-minimal decline), poor (low baseline-moderate decline), and very poor (low baseline-large decline). After TAVR, the most common trajectory was fair (54 [37.8%]), followed by good (33 [23.1%]), poor (21 [14.7%]), excellent (20 [14.0%]), and very poor (12 [8.4%]) trajectories. After SAVR, the most common trajectory was good (39 [37.9%]), followed by excellent (38 [36.9%]), fair (20 [19.4%]), poor (3 [2.9%]), and very poor (1 [1.0%]) trajectories. Preoperative frailty level was associated with lower probability of functional improvement and greater probability of functional decline. After TAVR, patients with CGA-FI level of 0.20 or lower had excellent (3 [50.0%]) or good (3 [50.0%]) trajectories, whereas most patients with CGA-FI level of 0.51 or higher had poor (10 [45.5%]) or very poor (5 [22.7%]) trajectories. After SAVR, most patients with CGA-FI level of 0.20 or lower had excellent (24 [58.5%]) or good (15 [36.6%]) trajectories compared with a fair trajectory (5 [71.4%]) in those with CGA-FI levels of 0.41 to 0.50. Postoperative delirium and major complications were associated with functional decline after TAVR (delirium present vs absent: 14 [50.0%] vs 11 [13.4%]; complications present vs absent: 14 [51.9%] vs 19 [16.4%]) or lack of improvement after SAVR (delirium present vs absent: 27 [69.2%] vs 31 [81.6%]; complications present vs absent: 10 [62.5%] vs 69 [79.3%]).

Conclusions And Relevance: The findings suggest that functional decline or lack of improvement is common in older adults with severe frailty undergoing TAVR or SAVR. Although this nonrandomized study does not allow comparison of the effectiveness between TAVR and SAVR, anticipated functional trajectories may inform patient-centered decision making and perioperative care to optimize functional outcomes.
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http://dx.doi.org/10.1001/jamainternmed.2018.6738DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6439710PMC
March 2019

Prevalence and Outcomes of Isolated Tricuspid Valve Surgery Among Medicare Beneficiaries.

Am J Cardiol 2019 01 27;123(1):132-138. Epub 2018 Sep 27.

Smith Clinical Outcomes Center and the Departments of Internal Medicine (Cardiovascular Division), Cardiac Surgery at the Beth Israel Deaconess Medical Center, Boston, Massachusetts.

We sought to characterize the clinical outcomes and to identify predictors of mortality undergoing isolated tricuspid valve surgery in the United States. We identified 5,164 patients undergoing isolated tricuspid valve surgery from the Centers for Medicare and Medicaid Services Medicare Provider Analysis and Review data between January 2003 and December 2014. The primary outcome was all cause 1-year mortality. A backward elimination method was performed to identify predictors of 1-year mortality. Tricuspid valve repair was performed in 2,494 (48.3%) patients and tricuspid valve replacement was performed in 2,670 (51.7%) patients. Perioperative and 1-year mortality rates were 9.9% and 24.1%, respectively. Predictors of 1-year mortality were age (p <0.001), chronic heart failure (p = 0.001, cirrhosis (p <0.001), carcinoid syndrome (p <0.001), chronic kidney disease (p = 0.001), secondary pulmonary hypertension (p = 0.023), endocarditis (p = 0.005), decubitus ulcer (p <0.001), malnutrition (p <0.001), replacement (p = 0.013), emergency procedure (p <0.001), and preprocedural shock (p <0.001). The C-statistic for 1-year mortality was 0.70 (95% confidence interval, 0.67 to 0.73). In conclusion, isolated tricuspid valve surgery is infrequently performed in the United States, and is associated with high 1-year mortality. Patients at higher risk for mortality can be identified based on the presence of a number of comorbidities at the time of surgery.
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http://dx.doi.org/10.1016/j.amjcard.2018.09.016DOI Listing
January 2019

Frailty Phenotype and Deficit Accumulation Frailty Index in Predicting Recovery After Transcatheter and Surgical Aortic Valve Replacement.

J Gerontol A Biol Sci Med Sci 2019 07;74(8):1249-1256

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

Background: Frailty phenotype and deficit-accumulation frailty index (FI) are widely used measures of frailty. Their performance in predicting recovery after surgical aortic valve replacement (SAVR) and transcatheter aortic valve replacement (TAVR) has not been compared.

Methods: Patients undergoing SAVR (n = 91) or TAVR (n = 137) at an academic medical center were prospectively assessed for frailty phenotype and FI. Outcomes were death or poor recovery, defined as a decline in ability to perform 22 daily activities and New York Heart Association class 3 or 4 at 6 months after surgery. The predictive ability of frailty phenotype versus FI and their additive value to a traditional surgical risk model were evaluated using C-statistics, net reclassification improvement (NRI), and integrated discrimination improvement.

Results: TAVR patients had higher prevalence of phenotypic frailty (85% vs 38%, p < .001) and greater mean FI (0.37 vs 0.24, p < .001) than SAVR patients. In the overall cohort, FI had a higher C-statistic than frailty phenotype (0.74 vs 0.63, p = .01) for predicting death or poor recovery. Adding FI to the traditional model improved prediction (NRI, 26.4%, p = .02; integrated discrimination improvement, 7.7%, p < .001), while adding phenotypic frailty did not (NRI, 4.0%, p = .70; integrated discrimination improvement, 1.6%, p = .08). The additive value of FI was evident in TAVR patients (NRI, 42.8%, p < .01) but not in SAVR patients (NRI, 25.0%, p = .29). Phenotypic frailty did not add significantly in either TAVR (NRI, 6.8%, p = .26) or SAVR patients (NRI, 25.0%, p = .29).

Conclusions: Deficit-accumulation FI provides better prediction of death or poor recovery than frailty phenotype in older patients undergoing SAVR and TAVR.
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http://dx.doi.org/10.1093/gerona/gly196DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6625585PMC
July 2019

Histopathological Demonstration of Subacute Endothelialization Following Aneurysm Retreatment with the Pipeline Embolization Device.

World Neurosurg 2018 Oct 18;118:156-160. Epub 2018 Jul 18.

Neurosurgical Service, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts, USA; Department of Neurosurgery, National Neuroscience Institute, King Fahad Medical City, Riyadh, Saudi Arabia. Electronic address:

Background: Endothelial cell coverage along the Pipeline embolization device (PED) is 1 of 2 primary proposed mechanisms of action of the device, along with induction of intra-aneurysmal thrombosis. The temporal course of endothelialization following device deployment is poorly understood in human patients.

Case Description: A 63-year-old female with a persistent aneurysm in the communicating segment of the internal carotid artery was treated with a second PED 14 months after the deployment of a first PED and subsequently developed a fatal intraparenchymal hemorrhage at 3 weeks postimplantation. Histopathological analysis at autopsy showed evidence of endothelialization along the second PED at this time, as well as neointimal growth between both devices. Patency of the vessel lumen with no intraluminal thrombus but thrombus showing early organization (endothelial cell ingrowth) was observed within the aneurysm dome. To our knowledge, this case represents the earliest demonstration of intimal cell growth along the PED.

Conclusions: Aneurysm healing via endothelialization following flow diverter treatment may occur subacutely and not chronically as previously stipulated.
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http://dx.doi.org/10.1016/j.wneu.2018.07.090DOI Listing
October 2018

Fatal Hemoptysis After Closure of Gastrobronchial Fistula Using an Amplatzer Vascular Device.

Ann Thorac Surg 2018 Feb;105(2):e71-e73

Division of Thoracic Surgery and Interventional Pulmonology, Beth Israel Deaconess Medical Center, Boston, Massachusetts. Electronic address:

The Amplatzer family of vascular devices has been used off-label for the treatment of complex gastrointestinal and airway fistulas. We report a case in which closure of a benign gastrobronchial fistula with the use of an Amplatzer device resulted in massive hemoptysis and death.
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http://dx.doi.org/10.1016/j.athoracsur.2017.09.015DOI Listing
February 2018

Mechanical discordance between left atrium and left atrial appendage.

Ann Card Anaesth 2018 Jan-Mar;21(1):82-84

Department of Anesthesia, Critical Care and Pain Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.

During standard transesophageal echocardiographic examinations in sinus rhythm (SR) patients, the left atrial appendage (LAA) is not routinely assessed with Doppler. Despite having a SR, it is still possible to have irregular activity in the LAA. This situation is even more important for SR patients where assessment of the left atrium is often foregone. We describe a case where we encountered this situation and briefly review how to assess the left atrium and its appendage in such a case scenario.
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http://dx.doi.org/10.4103/aca.ACA_90_17DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5791500PMC
October 2018

Prognostic Value of Combined CT Angiography and Myocardial Perfusion Imaging versus Invasive Coronary Angiography and Nuclear Stress Perfusion Imaging in the Prediction of Major Adverse Cardiovascular Events: The CORE320 Multicenter Study.

Radiology 2017 07 14;284(1):55-65. Epub 2017 Mar 14.

From the Laboratory of Cardiac Energetics, National Heart Lung and Blood Institute, National Institutes of Health, Bethesda, Md (M.Y.C., A.E.A.); InCor Heart Institute, University of São Paulo Medical School, Brazil, São Paulo, Brazil (C.E.R.); Johns Hopkins Hospital and School of Medicine, 600 N Wolfe St, Blalock 524, Baltimore, MD 21287 (A.A., R.T.G., J.M.M., A.L.V., R.J.C., V.C.M., J.A.B., J.A.C.L.); Department of Radiology, Charité Medical School-Humboldt, Berlin, Germany (M.D., M.L.); Memorial Heart Center, Iwate Medical University, Morioka, Japan (H.N., K.Y.); Department of Radiology, St. Luke's International Hospital, Tokyo, Japan (H.N.); Department of Radiology, Mie University Hospital, Tsu, Japan (K.K., H.S.); Department of Radiology, Beth Israel Deaconess Medical Center, Harvard University, Boston, Mass (R.L., M.E.C.); and Radiology Sector, Hospital Israelita Albert Einstein, São Paulo, Brazil (C.N.); From the Department of Cardiology, Rigshospitalet, University of Copenhagen, Denmark (K.F.K.); Keio University School of Medicine, Tokyo, Japan (M.J., S.K.); Department of Cardiology, Leiden University Medical Center, Leiden, the Netherlands (A.J.S.); Department of Cardiology, National Heart Centre, Singapore (S.Y.T.); Medi-Rad Associates, CT Centre, Mount Elizabeth Hospital, Singapore (J.H.); Department of Medical Imaging, Toronto General Hospital, Toronto, Ontario, Canada (N.P.); Faculty of Medicine, University of Ottawa, Ottawa, Ontario, Canada (F.J.R.); Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Md (M.B.M., C.C.); and Department of Nuclear Medicine and Cardiovascular Imaging, Brigham and Women's Hospital, Boston, Mass (M.F.D.C.).

Purpose To compare the prognostic importance (time to major adverse cardiovascular event [MACE]) of combined computed tomography (CT) angiography and CT myocardial stress perfusion imaging with that of combined invasive coronary angiography (ICA) and stress single photon emission CT myocardial perfusion imaging. Materials and Methods This study was approved by all institutional review boards, and written informed consent was obtained. Between November 2009 and July 2011, 381 participants clinically referred for ICA and aged 45-85 years were enrolled in the Combined Noninvasive Coronary Angiography and Myocardial Perfusion Imaging Using 320-Detector Row Computed Tomography (CORE320) prospective multicenter diagnostic study. All images were analyzed in blinded independent core laboratories, and a panel of physicians adjudicated all adverse events. MACE was defined as revascularization (>30 days after index ICA), myocardial infarction, or cardiac death; hospitalization for chest pain or congestive heart failure; or arrhythmia. Late MACE was defined similarly, except for patients who underwent revascularization within the first 182 days after ICA, who were excluded. Comparisons of 2-year survival (time to MACE) used standard Kaplan-Meier curves and restricted mean survival times bootstrapped with 2000 replicates. Results An MACE (49 revascularizations, five myocardial infarctions, one cardiac death, nine hospitalizations for chest pain or congestive heart failure, and one arrhythmia) occurred in 51 of 379 patients (13.5%). The 2-year MACE-free rates for combined CT angiography and CT perfusion findings were 94% negative for coronary artery disease (CAD) versus 82% positive for CAD and were similar to combined ICA and single photon emission CT findings (93% negative for CAD vs 77% positive for CAD, P < .001 for both). Event-free rates for CT angiography and CT perfusion versus ICA and single photon emission CT for either positive or negative results were not significantly different for MACE or late MACE (P > .05 for all). The area under the receiver operating characteristic curve (AUC) for combined CT angiography and CT perfusion (AUC = 68; 95% confidence interval [CI]: 62, 75) was similar (P = .36) to that for combined ICA and single photon emission CT (AUC = 71; 95% CI: 65, 79) in the identification of MACE at 2-year follow-up. Conclusion Combined CT angiography and CT perfusion enables similar prediction of 2-year MACE, late MACE, and event-free survival similar to that enabled by ICA and single photon emission CT. RSNA, 2017 Online supplemental material is available for this article.
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http://dx.doi.org/10.1148/radiol.2017161565DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5495129PMC
July 2017

12-Month Coronary Angiography, Intravascular Ultrasound and Histology Evaluation of a Novel Fully Bioabsorbable Poly-L-Lactic Acid/Amorphous Calcium Phosphate Scaffolds in Porcine Coronary Arteries.

J Biomed Nanotechnol 2016 Apr;12(4):743-52

Our previous studies have confirmed the superior biocompatibility of the poly-L-lactic acid/amorphous calcium phosphate (PLLA/ACP) scaffolds (PowerScaffold) compared to PLLA scaffolds and their similar 6-month radial strength compared with TAXUS stents. In order to conduct further dynamic observations on the performance of the PowerScaffold after 12-month implantation compared with the TAXUS stents. Twenty PowerScaffold and 20 TAXUS were implanted in porcine coronary arteries. At 12-month follow-up, Quantitative Coronary Angiography showed that the stent reference vessel diameter (3.19 ± 0.25 mm vs. 2.75 ± 0.22 mm, p < 0.05), the mean lumen diameter (3.07 ± 0.22 mm vs. 2.70 ± 0.17 mm, p < 0.05) and the late lumen gain (0.45 ± 0.07 mm vs. 0.06 ± 0.06 mm, p < 0.01) were all significantly greater with the PowerScaffold than the TAXUS. As well, Intravascular Ultrasound showed the stent reference vessel area (7.74 ± 0.48 mm2 vs. 6.96 ± 0.51 mm2, p < 0.05), the mean stent area (7.49 ± 0.46 mm2 vs. 6.53 ± 0.47 mm2, p < 0.05) and the mean lumen area (7.22 ± 0.50 mm2 vs. 6.00 ± 0.48 mm2, p < 0.01) were all significantly greater with the PowerScaffold than the TAXUS. The luminal patency rate of the PowerScaffold significantly increased from 72.45 ± 6.84% at 1 month to 93.54 ± 8.15% at 12 months (p < 0.01) while the TAXUS stents were associated with a non-significant decreasing trend (89.44 ± 8.44% vs. 86.53 ± 8.22%). Pathology indicated the average thickness of the struts degraded by 14.25 ± 3.04 μm at 1 month, 23.39 ± 2.45 μm at 6 months and 35.54 ± 2.20 μm at 12 months. Immunohistochemical examination showed that the expression of inflammatory factors NF-κB gradually decreased from 1-month to 12-month (36.79 ± 4.78 vs. 5.79 ± 2.85, P < 0.01). As the late lumen gain of arteries implanted with the PowerScaffold increases over time with the growth of vessels, it effectively reverse the late vascular negative remodeling observed with the TAXUS stents, providing a better option for lumen restoration treatment in clinical practice.
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http://dx.doi.org/10.1166/jbn.2016.2241DOI Listing
April 2016

A Complex Atrial Septal Defect and Three-Dimensional Echocardiography: A Question and an Answer.

J Cardiothorac Vasc Anesth 2016 Aug 1;30(4):1050-2. Epub 2015 Oct 1.

Departments of Anesthesia. Electronic address:

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http://dx.doi.org/10.1053/j.jvca.2015.09.027DOI Listing
August 2016

6-Month Follow-Up of a Novel Biodegradable Drug-Eluting Stent Composed of Poly-L-Lactic Acid and Amorphous Calcium Phosphate Nanoparticles in Porcine Coronary Artery.

J Biomed Nanotechnol 2015 Oct;11(10):1819-25

Rationale: We reported previously, in porcine coronary arteries, that the novel biodegradable PowerStent Absorb paclitaxel-eluting stent had improved and sustained structural strength and functional performance at one month post-implantation.

Objective: To report the stent performance at 6-month follow-up.

Methods And Results: Six PowerStent Absorb and six TAXUS stents were randomly implanted in the left anterior descending and right coronary arteries of six Tibet miniature pigs. Quantitative coronary angiography (QCA) and intravascular ultrasound (IVUS) images were obtained at the time of implantation (T0) and at 6 months (T6). Two animals were sacrificed at T6 for histopathological evaluation. At T6, QCA showed that the mean luminal vascular diameter (mLD) between the PowerStent and the TAXUS stents were similar (2.36 ± 0.38 vs. 2.61 ± 0.31, respectively). Based on the IVUS analysis, the mLD and the mean lumen cross-sectional area (mCSA) in the PowerStent-treated arteries were similar between T0 and T6 (mLD: 2.74 ± 0.13 vs. 2.70 ± 0.20 and mCSA: 6.81 ± 0.62 mm2 vs. 6.68 ± 0.94 mm2). Histopathology showed that the PowerStent stents were well apposed to the vessel wall with no recoil, strut fracture and thrombus formation. The stents were fully covered with a layer of endothelial cells.

Conclusions: At six-month post-implantation, the PowerStent Absorb stents maintained their structural strength and functional performance. The development of restenosis was controlled, no stent thrombosis was observed and the stents were fully re-endothelialized. These results suggest the PowerStent Absorb stent is safe and effective for up to 6 months when implanted in porcine coronary arteries.
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http://dx.doi.org/10.1166/jbn.2015.2102DOI Listing
October 2015

Relationship of left ventricular mass to coronary atherosclerosis and myocardial ischaemia: the CORE320 multicenter study.

Eur Heart J Cardiovasc Imaging 2015 Feb 2;16(2):166-76. Epub 2014 Nov 2.

Division of Cardiology, Department of Medicine, Johns Hopkins University School of Medicine, Blalock 524, 600 N. Wolfe Street, Baltimore, MD 21287, USA

Aims: The aim of this study was to investigate the association of left ventricular mass (LVM) with coronary atherosclerosis and myocardial infarction (MI).

Methods And Results: Patients (n = 338) underwent 320 × 0.5 mm detector row coronary computed tomography (CT) angiography, invasive coronary angiography (ICA), and single-photon emission CT (SPECT) myocardial perfusion imaging. Quantitative coronary atheroma volume was obtained from the CT images for the entire coronary tree (19-segment model) with an arterial contour detection algorithm. Normalized total atheroma volume (NormTAV) was analysed to reflect quantitative total atheroma volume. LVM was measured on myocardial CT images and indexed to height to the power of 2.7 (LVMi). Patients with obstructive coronary artery disease (CAD) were defined as those with ≥50% diameter stenosis by quantitative ICA. Abnormal perfusion defect was defined as ≥1 abnormal myocardial segment by SPECT. The association of LVMi with coronary atherosclerosis and myocardial perfusion defect on SPECT at the patient level was determined with uni- and multivariable linear and logistic regression analyses. Obstructive CAD was present in 60.0% of enrolled patients. LVMi was independently associated with abnormal summed rest score [SRS; odds ratio (OR), 1.07; 95% confidence interval (CI), 1.03-1.09] and summed stress score (OR, 1.04; 95% CI, 1.01-1.07). An increase in LVMi was also independently associated with that in NormTAV (coefficient, 10.44; 95% CI, 1.50-19.39) and SRS ≥1 (OR, 1.05; 95% CI, 1.01-1.10), even after adjusting for cardiovascular risk factors in patients without previous MI.

Conclusions: LVM was independently associated with the presence of coronary artery atherosclerosis and MI.
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http://dx.doi.org/10.1093/ehjci/jeu217DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4318928PMC
February 2015

Novel biodegradable drug-eluting stent composed of poly-L-lactic acid and amorphous calcium phosphate nanoparticles demonstrates improved structural and functional performance for coronary artery disease.

J Biomed Nanotechnol 2014 Jul;10(7):1194-204

Bioabsorbable drug-eluting stents (BDES) offer multiple advantages over a permanent bare metal stent (BMS) for coronary artery disease (CAD). However, current BDES remains two major issues: inferior radial strength and biocompatibility. PowerStent Absorb BDES, fabricated by co-formulating amorphous calcium phosphate (ACP) nanoparticles with poly-L-lactic acid (PLLA/ACP, 98/2, w/w) and 2% Paclitaxel (PAX, w/w) was designed to address these issues. Two cohorts of 6 miniature pigs were each implanted with PLLA/PAX (control, 2% PAX, w/w) or PowerStent Absorb BDES. After 1 month in-vivo study, histological analyses showed significantly reduced restenosis in the PowerStent Absorb BDES cohort relative to the control cohort (44.49 +/- 410.49% vs. 64.47 +/- 16.2%, p < 0.05). Stent recoil (21.57 +/- 5.36% vs. 33.81 +/- 11.49, P < 0.05) and inflammation (3.01 +/- 0.62 vs. 4.07 +/- 0.86, P < 0.01) were also obviously decreased. From in-vitro studies, PLLA/ACP/PAX stent tube maintained significantly greater radial strength than control group during 6 months in-vitro degradation (PLLA/ACP/PAX vs. PLLA/PAX: before hydrolysis: 82.4 +/- 1.9 N vs.74.8 +/- 3.8 N; 6 weeks: 73.9 +/- 1.8 N vs. 68.0 +/- 5.3 N; 3 months: 73.5 +/- 3.4 N vs.67.2 +/- 3.8 N; 6 months: 56.3 +/- 8.1 N vs. 57.5 +/- 4.9 N). Moreover, ACP facilitated the hydrolytic degradation of PLLA compared with control one (62.6% vs. 49.8%), meanwhile, it also increased the crystallinity of PLLA (58.4% vs. 50.7%) at 6 months. From SEM observations, ACP created nanometer pores that enlarge gradually to a micrometer scale as degradation proceeds. The changes of the porosity may result in greatly promoting re-endothelialization.
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http://dx.doi.org/10.1166/jbn.2014.1868DOI Listing
July 2014

Improved biocompatibility of poly(lactic-co-glycolic acid) orv and poly-L-lactic acid blended with nanoparticulate amorphous calcium phosphate in vascular stent applications.

J Biomed Nanotechnol 2014 Jun;10(6):900-10

Biodegradable polymers used as vascular stent coatings and stent platforms encounter a major challenge: biocompatibility in vivo, which plays an important role in in-stent restenosis (ISR). Co-formulating amorphous calcium phosphate (ACP) into poly(lactic-co-glycolic acid) (PLGA) or poly-L-lactic acid (PLLA) was investigated to address the issue. For stent coating applications, metal stents were coated with polyethylene-co-vinyl acetate/poly-n-butyl methacrylate (PEVA/PBMA), PLGA or PLGA/ACP composites, and implanted into rat aortas for one and three months. Comparing with both PEVA/PBMA and PLGA groups after one month, the results showed that stents coated with PLGA/ACP had significantly reduced restenosis (PLGA/ACP vs. PEVA/PBMA vs. PLGA: 21.24 +/- 2.59% vs. 27.54 +/- 1.19% vs. 32.12 +/- 3.93%, P < 0.05), reduced inflammation (1.25 +/- 0.35 vs. 1.77 +/- 0.38 vs. 2.30 +/- 0.21, P < 0.05) and increased speed of re-endothelialization (1.78 +/- 0.46 vs. 1.17 +/- 0.18 vs. 1.20 +/- 0.18, P < 0.05). After three months, the PLGA/ACP group still displayed lower inflammation score (1.33 +/- 0.33 vs. 2.27 +/- 0.55, P < 0.05) and higher endothelial scores (2.33 +/- 0.33 vs. 1.20 +/- 0.18, P < 0.05) as compared with the PEVA/PBMA group. Moreover, for stent platform applications, PLLA/ACP stent tube significantly reduced the inflammatory cells infiltration in the vessel walls of rabbit iliac arteries relative to their PLLA cohort (NF-kappaB-positive cells: 23.31 +/- 2.33/mm2 vs. 9.34 +/- 1.35/mm2, P < 0.05). No systemic biochemical or pathological evidence of toxicity was found in either PLGA/ACP or PLLA/ACP. The co-formulation of ACP into PLGA and PLLA resulted in improved biocompatibility without systemic toxicity.
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http://dx.doi.org/10.1166/jbn.2014.1856DOI Listing
June 2014

Computed tomography angiography and perfusion to assess coronary artery stenosis causing perfusion defects by single photon emission computed tomography: the CORE320 study.

Eur Heart J 2014 May 19;35(17):1120-30. Epub 2013 Nov 19.

Division of Cardiology, Department of Medicine, Johns Hopkins Hospital and School of Medicine, 600 N. Wolfe St., Blalock 524, Baltimore, MD 21287, USA.

Aims: To evaluate the diagnostic power of integrating the results of computed tomography angiography (CTA) and CT myocardial perfusion (CTP) to identify coronary artery disease (CAD) defined as a flow limiting coronary artery stenosis causing a perfusion defect by single photon emission computed tomography (SPECT).

Methods And Results: We conducted a multicentre study to evaluate the accuracy of integrated CTA-CTP for the identification of patients with flow-limiting CAD defined by ≥50% stenosis by invasive coronary angiography (ICA) with a corresponding perfusion deficit on stress single photon emission computed tomography (SPECT/MPI). Sixteen centres enroled 381 patients who underwent combined CTA-CTP and SPECT/MPI prior to conventional coronary angiography. All four image modalities were analysed in blinded independent core laboratories. The prevalence of obstructive CAD defined by combined ICA-SPECT/MPI and ICA alone was 38 and 59%, respectively. The patient-based diagnostic accuracy defined by the area under the receiver operating characteristic curve (AUC) of integrated CTA-CTP for detecting or excluding flow-limiting CAD was 0.87 [95% confidence interval (CI): 0.84-0.91]. In patients without prior myocardial infarction, the AUC was 0.90 (95% CI: 0.87-0.94) and in patients without prior CAD the AUC for combined CTA-CTP was 0.93 (95% CI: 0.89-0.97). For the combination of a CTA stenosis ≥50% stenosis and a CTP perfusion deficit, the sensitivity, specificity, positive predictive, and negative predicative values (95% CI) were 80% (72-86), 74% (68-80), 65% (58-72), and 86% (80-90), respectively. For flow-limiting disease defined by ICA-SPECT/MPI, the accuracy of CTA was significantly increased by the addition of CTP at both the patient and vessel levels.

Conclusions: The combination of CTA and perfusion correctly identifies patients with flow limiting CAD defined as ≥50 stenosis by ICA causing a perfusion defect by SPECT/MPI.
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http://dx.doi.org/10.1093/eurheartj/eht488DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6693293PMC
May 2014

Ethanol promotes arteriogenesis and restores perfusion to chronically ischemic myocardium.

Circulation 2013 Sep;128(11 Suppl 1):S136-43

Division of Cardiothoracic Surgery, Cardiovascular Research Center, Warren Alpert Medical School, Brown University, Providence, RI (A.D.L., N.Y.E., Y.L., J.F., T.A.B., N.W.K., F.W.S.); and Cardiology Division, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA (R.J.L.).

Background: Moderate alcohol consumption is known to be cardioprotective compared with either heavy drinking or complete abstinence. We assessed the hypothesis that ethanol supplementation would improve myocardial function in the setting of chronic ischemia.

Methods And Results: Sixteen male Yorkshire swine underwent placement of an ameroid constrictor into the left circumflex artery to induce chronic myocardial ischemia. Postoperatively, animals were supplemented with either 90 mL of ethanol (EtOH) daily (50%/V, EtOH) or 80 g of sucrose of equal caloric value (SUC), serving as controls. Seven weeks after ameroid placement, arteriolar density (1.74 ± 0.210% versus 3.11 ± 0.368% area of arterioles per low-powered field in sucrose (SUC) versus EtOH; P=0.004), myocardial perfusion (ratio of blood flow to the at-risk myocardium compared with the normal ventricle during demand pacing was 0.585 ± 0.107 versus 1.08 ± 0.138 for SUC versus EtOH; P=0.014), and microvascular reactivity were significantly increased in ethanol-treated animals compared with controls in the at-risk myocardium. Analysis of vascular endothelial growth factor and NOTCH pathway signaling suggested proneovascular and proliferative activity in the ischemic area. The average peak blood alcohol level in the treatment group was 40 ± 4 mg/dL, consistent with levels of moderate drinking in humans.

Conclusions: Ethanol supplementation increased arteriolar density and significantly improved myocardial perfusion and endothelium-dependent vasorelaxation in chronically ischemic myocardium. These findings suggest that, at moderate doses, ethanol directly promotes vasculogenesis and improves microvascular function, resulting in significant improvements in myocardial perfusion in the setting of chronic ischemia.
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http://dx.doi.org/10.1161/CIRCULATIONAHA.112.000207DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3983870PMC
September 2013

Patterns of coronary arterial lesion calcification by a novel, cross-sectional CT angiographic assessment.

Int J Cardiovasc Imaging 2013 Oct 24;29(7):1619-27. Epub 2013 May 24.

Division of Cardiology, Johns Hopkins University, 600 North Wolfe Street, Blalock 524, Baltimore, MD, 21287-0409, USA.

To investigate the patterns and diagnostic implications of coronary arterial lesion calcification by CT angiography (CTA) using a novel, cross-sectional grading method, we studied 371 patients enrolled in the CorE-64 study who underwent CTA and invasive angiography for detecting coronary artery stenoses by quantitative coronary angiography (QCA). The number of quadrants involving calcium on a cross-sectional view for ≥ 30 and ≥ 50 % lesions in 4,511 arterial segments was assessed by CTA according to: noncalcified, mild (one-quadrant), moderate (two-quadrant), severe (three-quadrant) and very severe (four-quadrant calcium). Area under the receiver operating characteristic curve (AUC) were used to evaluate CTA diagnostic accuracy and agreement versus. QCA for plaque types. Only 4 % of ≥ 50 % stenoses by QCA were very severely calcified while 43 % were noncalcified. AUC for CTA to detect ≥ 50 % stenoses by QCA for non-calcified, mildly, moderately, severely, and very severely calcified plaques were 0.90, 0.88, 0.83, 0.76 and 0.89, respectively (P < 0.05). In 198 lesions with severe calcification, the presence or absence of a visible residual lumen by CTA was associated with ≥ 50 % stenosis by QCA in 20.3 and 76.9 %, respectively. Kappa was 0.93 for interobserver variability in evaluating plaque calcification. We conclude that calcification of individual coronary artery lesions can be reliably graded using CTA. Most ≥ 50 % coronary artery stenoses are not or only mildly calcified. If no residual lumen is seen on CTA, calcified lesions are predictive of ≥ 50 % stenoses and vice versa. CTA diagnostic accuracy for detecting ≥ 50 % stenoses is reduced in lesions with more than mild calcification due to lower specificity.
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http://dx.doi.org/10.1007/s10554-013-0240-8DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3796157PMC
October 2013

Effects of red wine and vodka on collateral-dependent perfusion and cardiovascular function in hypercholesterolemic swine.

Circulation 2012 Sep;126(11 Suppl 1):S65-72

Division of Cardiothoracic Surgery, Warren Alpert School of Medicine, Brown University, Providence, RI 02905, USA.

Background: Moderate consumption of alcohol, particularly red wine, has been shown to decrease cardiac risk. We used a hypercholesterolemic swine model of chronic ischemia to examine the effects of 2 alcoholic beverages on the heart.

Methods And Results: Yorkshire swine fed a high-cholesterol diet underwent left circumflex ameroid constrictor placement to induce chronic ischemia at 8 weeks of age. One group (HCC, n=9) continued on the diet alone, the second (HCW, n=8) was supplemented with red wine (pinot noir, 12.5% alcohol, 375 mL daily), and the third (HCV, n=9) was supplemented with vodka (40% alcohol, 112 mL daily). After 7 weeks, cardiac function was measured, and ischemic myocardium was harvested for analysis of perfusion, myocardial fibrosis, vessel function, protein expression, oxidative stress, and capillary density. Platelet function was measured by aggregometry. Perfusion to the ischemic territory as measured by microsphere injection was significantly increased in both HCW and HCV compared with HCC at rest, but in only the HCW group under ventricular pacing. Microvessel relaxation response to adenosine 5'-diphosphate was improved in the HCW group alone as was regional contractility in the ischemic territory, although myocardial fibrosis was decreased in both HCW and HCV. Expression of proangiogenic proteins phospho-endothelial nitric oxide synthase and vascular endothelial growth factor was increased in both HCW and HCV, whereas phospho-mammalian target of rapamycin was increased only in the HCV group. Expression of Sirt-1 and downstream antioxidant phospho-FoxO1 was increased only in the HCW group. Protein oxidative stress was decreased in the HCW group alone, whereas capillary density was increased only in the HCV group. There was no significant difference in platelet function between groups.

Conclusion: Moderate consumption of red wine and vodka may reduce cardiovascular risk by improving collateral-dependent perfusion through different mechanisms. Red wine may offer increased cardioprotection related to its antioxidant properties.
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http://dx.doi.org/10.1161/CIRCULATIONAHA.111.082172DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3448932PMC
September 2012