Research Spotlight

Palazzuoli, A., Ruocco, G., Tecson, K.M. and McCullough, P.A. (2021). “Screening, detection, and management of heart failure in the SARS-CoV2 (COVID-19) pandemic.” Heart Fail Rev Jan 6;1-7. [ Epub ahead of print]. 1-7.

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Observational studies suggest that a heart failure (HF) diagnosis carries a poor prognosis in subjects with severe SARS-CoV2 (COVID-19) infection, but it is unknown whether this association reflects direct myocardial damage due to COVID-19 or the consequence of preexisting cardiac defects and related cardiovascular disease (CVD) risk burden. Although the close relation between CVD and COVID-19 outcomes is well established, contrasting data exists about the occurrence of HF complications during COVID-19 infection. Therefore, a specific algorithm focused on diagnostic differentiation in acute patients distinguishing between acute HF and acute respiratory distress syndrome related to COVID-19 is needed. Further, several concerns exist for the management of patients with an uncertain diagnosis and acute dyspnea, the exact relationship existing between COVID-19 and HF. Therefore, the treatment for subjects with both COVID-19 and HF and which criteria may be defined for domiciliary or hospital management, remain poorly defined. Herein, we describe practices to be adopted in order to address these concerns and avoid further virus spread among patients, l and their familiars involved in such patients’ care.

Young, S., Larson, L., Bermudez, J., Mohei, H., Rostambeigi, N., Golzarian, J. and Mahgoub, A. (2021). “Evaluation of the frequency and factors predictive of hernia incarceration following transjugular intrahepatic portosystemic shunt placement.” Clin Radiol Feb 4;S0009-9260(21)00009-X. [Epub ahead of print].

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AIM: To examine the frequency and predictive factors for bowel incarceration following transjugular intrahepatic portosystemic shunts (TIPS) placement to treat refractory cirrhosis-induced ascites. MATERIALS AND METHODS: Ninety-nine patients with known hernias at the time of TIPS placement were identified. Their electronic medical records were reviewed and pertinent pre-procedural, procedural, and outcome variables were recorded. Patients were divided between those that suffered incarceration (study group) and a control group of those with a hernia who did not suffer incarceration. RESULTS: Twelve of the 99 patients (12.1%) suffered hernia incarceration, of which seven (7.1%) suffered incarceration in the first 90 days. One patient who suffered incarceration ultimately died from complications of the incarceration. When comparing all patients who suffered incarceration to controls, incarceration patients were found to have significantly higher albumin levels (mean 3.13 versus 2.73, p=0.02). When just considering those who had incarcerations in the first 90 days to controls, incarceration patients were less likely to have improvement in their ascites (p=0.04). CONCLUSIONS: Incarcerated hernias occur frequently after TIPS placement and can lead to significant morbidity and mortality. Clinicians should be aware of this complication and counsel patients on presenting symptoms prior to placement.

Wang, R., Takahashi, K., Garg, S., Thuijs, D., Kappetein, A.P., Mack, M.J., Morice, M.C., Mohr, F.W., Curzen, N., Davierwala, P., Milojevic, M., van Geuns, R.J., Head, S.J., Onuma, Y., Holmes, D.R., Jr. and Serruys, P.W. (2021). “Ten-year all-cause death following percutaneous or surgical revascularization in patients with prior cerebrovascular disease: insights from the SYNTAX Extended Survival study.” Clin Res Cardiol Jan 30. [ Epub ahead of print].

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BACKGROUND: Coronary bypass artery grafting (CABG) has a higher procedural risk of stroke than percutaneous coronary intervention (PCI), but may offer better long-term survival. The optimal revascularization strategy for patients with prior cerebrovascular disease (CEVD) remains unclear. METHODS AND RESULTS: The SYNTAXES study assessed the vital status out to 10 year of patients with three-vessel disease and/or left main coronary artery disease enrolled in the SYNTAX trial. The relative efficacy of PCI vs. CABG in terms of 10 year all-cause death was assessed according to prior CEVD. The primary endpoint was 10 year all-cause death. The status of prior CEVD was available in 1791 (99.5%) patients, of whom 253 patients had prior CEVD. Patients with prior CEVD were older and had more comorbidities (medically treated diabetes, insulin-dependent diabetes, metabolic syndrome, peripheral vascular disease, chronic obstructive pulmonary disease, impaired renal function, and congestive heart failure), compared with those without prior CEVD. Prior CEVD was an independent predictor of 10 year all-cause death (adjusted HR: 1.35; 95% CI: 1.04-1.73; p = 0.021). Patients with prior CEVD had a significantly higher risk of 10 year all-cause death (41.1 vs. 24.1%; HR: 1.92; 95% CI: 1.54-2.40; p < 0.001). The risk of 10 year all-cause death was similar between patients receiving PCI or CABG irrespective of the presence of prior CEVD (p(-interaction) = 0.624). CONCLUSION: Prior CEVD was associated with a significantly increased risk of 10 year all-cause death which was similar in patients treated with PCI or CABG. These results do not support preferential referral for PCI rather than CABG in patients with prior CEVD. TRIAL REGISTRATION: SYNTAX: ClinicalTrials.gov reference: NCT00114972. SYNTAX Extended Survival: ClinicalTrials.gov reference: NCT03417050.

Thourani, V.H., Edelman, J.J., Holmes, S.D., Nguyen, T.C., Carroll, J., Mack, M.J., Kapadia, S., Tang, G.H.L., Kodali, S., Kaneko, T., Meduri, C.U., Forcillo, J., Ferdinand, F.D., Fontana, G., Suwalski, P., Kiaii, B., Balkhy, H., Kempfert, J., Cheung, A., Borger, M.A., Reardon, M., Leon, M.B., Popma, J.J. and Ad, N. (2021). “The International Society for Minimally Invasive Cardiothoracic Surgery Expert Consensus Statement on Transcatheter and Surgical Aortic Valve Replacement in Low- and Intermediate-Risk Patients: A Meta-Analysis of Randomized and Propensity-Matched Studies.” Innovations (Phila) Jan 25;1556984520978316. [Epub ahead of print]. 1556984520978316.

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OBJECTIVE: There is an increasing amount of evidence supporting use of transcatheter aortic valve replacement (TAVR) for treatment of aortic stenosis in patients at low or intermediate risk for surgical aortic valve replacement (SAVR). TAVR is now approved for use in all patient cohorts. Despite this, there remains debate about the relative efficacy of TAVR compared with SAVR in lower-risk cohorts and various subgroups of patients. We performed a systematic review and meta-analysis of randomized controlled trials (RCTs) and propensity-matched trials to guide a consensus among expert cardiologists and surgeons. METHODS: Studies comparing TAVR and SAVR in low- and intermediate-risk patients were identified by a thorough search of the major databases. Mortality, stroke, and other perioperative outcomes were assessed at 30 days and 1 year. RESULTS: Early mortality was lower in TAVR compared to SAVR in RCTs, but not propensity-matched studies in low-risk cohorts (0.66% vs 1.5%; odds ratio [OR] = 0.44, 95% confidence interval [CI] 0.20 to 0.98, I(2) = 0%). No difference in mortality between TAVR and SAVR was identified in intermediate-risk patients at early or later time points. Incidence of perioperative stroke in 3 low-risk RCTs was significantly lower in TAVR (0.4%) than SAVR (1.4%; OR = 0.33, 95% CI 0.13 to 0.81, I(2) = 0%). There was no difference in stroke for intermediate-risk patients between TAVR and SAVR. The expert panel of cardiologists and cardiac surgeons provided recommendations for TAVR and SAVR in various clinical scenarios. CONCLUSIONS: In RCTs comparing TAVR and SAVR in low-risk patients, early mortality and stroke were lower in TAVR, but did not differ at 1 year. There was no difference in mortality and stroke in intermediate-risk patients. The Multidisciplinary Heart Team must consider individual patient characteristics and preferences when recommending TAVR or SAVR. The decision must consider the long-term management of each patient’s aortic valve disease.

Kodali, S., Hahn, R.T., Eleid, M.F., Kipperman, R., Smith, R., Lim, D.S., Gray, W.A., Narang, A., Pislaru, S.V., Koulogiannis, K., Grayburn, P., Fowler, D., Hawthorne, K., Dahou, A., Deo, S.H., Vandrangi, P., Deuschl, F., Mack, M.J., Leon, M.B., Feldman, T. and Davidson, C.J. (2021). “Feasibility Study of the Transcatheter Valve Repair System for Severe Tricuspid Regurgitation.” J Am Coll Cardiol 77(4): 345-356.

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BACKGROUND: Tricuspid regurgitation (TR) is a prevalent disease with limited treatment options. OBJECTIVES: This is the first 30-day report of the U.S. single-arm, multicenter, prospective CLASP TR early feasibility study of the PASCAL transcatheter valve repair system in the treatment of TR. METHODS: Patients with symptomatic TR despite optimal medical therapy, reviewed by the local heart team and central screening committee, were eligible for the study. Data were collected at baseline, discharge, and the 30-day follow-up and were reviewed by an independent clinical events committee and echocardiographic core laboratory. Feasibility endpoints included safety (composite major adverse event [MAE] rate), echocardiographic, clinical, and functional endpoints. RESULTS: Of the 34 patients enrolled in the study, the mean age was 76 years, 53% were women, the mean Society of Thoracic Surgeons score was 7.3%, 88% had atrial fibrillation/flutter, 97% had severe or greater TR, and 79% had New York Heart Association (NYHA) functional class III/IV symptoms. Twenty-nine patients (85%) received implants; at 30 days, 85% of them achieved a TR severity reduction of at least 1 grade, with 52% with moderate or less TR (p < 0.001). The MAE rate was 5.9%, and none of the patients experienced cardiovascular mortality, stroke, myocardial infarction, renal complication, or reintervention. Eighty-nine percent of the patients improved to NYHA functional class I/II (p < 0.001), the mean 6-min walk distance improved by 71 m (p < 0.001), and the mean Kansas City Cardiomyopathy Questionnaire score improved by 15 points (p < 0.001). CONCLUSIONS: In this early experience, the repair system performed as intended, with substantial TR reduction, favorable safety results with a low MAE rate, no mortality or reintervention, and significant improvements in functional status, exercise capacity, and quality of life. (Edwards CLASP TR EFS [CLASP TR EFS]; NCT03745313).