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Background: Placement of an interatrial shunt device reduces pulmonary capillary wedge pressure during exercise in patients with heart failure and preserved or mildly reduced ejection fraction. We aimed to investigate whether an interatrial shunt can reduce heart failure events or improve health status in these patients., Methods: In this randomised, international, blinded, sham-controlled trial performed at 89 health-care centres, we included patients (aged ≥40 years) with symptomatic heart failure, an ejection fraction of at least 40%, and pulmonary capillary wedge pressure during exercise of at least 25 mm Hg while exceeding right atrial pressure by at least 5 mm Hg. Patients were randomly assigned (1:1) to receive either a shunt device or sham procedure. Patients and outcome assessors were masked to randomisation. The primary endpoint was a hierarchical composite of cardiovascular death or non-fatal ischemic stroke at 12 months, rate of total heart failure events up to 24 months, and change in Kansas City Cardiomyopathy Questionnaire overall summary score at 12 months. Pre-specified subgroup analyses were conducted for the heart failure event endpoint. Analysis of the primary endpoint, all other efficacy endpoints, and safety endpoints was conducted in the modified intention-to-treat population, defined as all patients randomly allocated to receive treatment, excluding those found to be ineligible after randomisation and therefore not treated. This study is registered with ClinicalTrials.gov, NCT03088033., Findings: Between May 25, 2017, and July 24, 2020, 1072 participants were enrolled, of whom 626 were randomly assigned to either the atrial shunt device (n=314) or sham procedure (n=312). There were no differences between groups in the primary composite endpoint (win ratio 1·0 [95% CI 0·8-1·2]; p=0·85) or in the individual components of the primary endpoint. The prespecified subgroups demonstrating a differential effect of atrial shunt device treatment on heart failure events were pulmonary artery systolic pressure at 20W of exercise (p interaction =0·002 [>70 mm Hg associated with worse outcomes]), right atrial volume index (p interaction =0·012 [≥29·7 mL/m 2 , worse outcomes]), and sex (p interaction =0·02 [men, worse outcomes]). There were no differences in the composite safety endpoint between the two groups (n=116 [38%] for shunt device vs n=97 [31%] for sham procedure; p=0·11)., Interpretation: Placement of an atrial shunt device did not reduce the total rate of heart failure events or improve health status in the overall population of patients with heart failure and ejection fraction of greater than or equal to 40%., Funding: Corvia Medical., Competing Interests: Declaration of interests SJS reports research grants from the National Institutes of Health (NIH; U54 HL160273, R01 HL107577, R01 HL127028, R01 HL140731, and R01 HL149423), Actelion, AstraZeneca, Corvia, Novartis, and Pfizer; and personal fees from Abbott, Actelion, AstraZeneca, Amgen, Aria CV, Axon Therapies, Bayer, Boehringer-Ingelheim, Boston Scientific, Bristol Myers Squibb, Cardiora, Coridea, CVRx, Cyclerion, Cytokinetics, Edwards Lifesciences, Eidos, Eisai, Imara, Impulse Dynamics, Intellia, Ionis, Ironwood, Lilly, Merck, MyoKardia, Novartis, Novo Nordisk, Pfizer, Prothena, Regeneron, Rivus, Sanofi, Shifamed, Tenax, Tenaya, and United Therapeutics. BAB reports research funding from the National Institutes of Health, Axon, AstraZeneca, Corvia, Medtronic, GlaxoSmithKline, Mesoblast, Novartis, and Tenax Therapeutics; and personal fees from Actelion, Amgen, Aria, Boehringer Ingelheim, Edwards, Eli Lilly, Imbria, Janssen, Merck, Novo Nordisk, and VADovations. ESC reports personal fees from Abbott, EBR systems, Medtronic, Intershunt, LivaNova, CVRx, and Cardionomics. GH reports personal fees from AstraZeneca, Bayer, Boehringer Ingelheim, Impulse Dynamics, Novartis, Pfizer, Servier, and Vifor Pharma. RK reports personal fees from Medtronic, Impulse Dynamics, and Cardionomic. SEL reports personal fees from Axon Therapies and CVRx. PL reports research grants from Abbott Vascular, Edwards Lifesciences, and ReCor. JMM reports personal fees from Corvia. RCM reports personal fees from Pfizer, Akcea, Eidos, Alnylam, and CareDx. SDS reports research grants from Actelion, Alnylam, Amgen, AstraZeneca, Bellerophon, Bayer, Bristol Myer Squibb, Celladon, Cytokinetics, Eidos, Gilead, GlaxoSmithKline, Ionis, Lilly, Mesoblast, MyoKardia, NIH, Neurotronik, Novartis, NovoNordisk, Respicardia, Sanofi Pasteur, Theracos, and US2.AI; and personal fees from Abbott, Action, Akros, Alnylam, Amgen, Arena, AstraZeneca, Bayer, Boeringer Ingelheim, Bristol Myers Squibb, Cardior, Cardurion, Corvia, Cytokinetics, Daiichi-Sankyo, GlaxoSmithKline, Lilly, Merck, Myokardia, Novartis, Roche, Theracos, Quantum Genomics, Cardurion, Janssen, Cardiac Dimensions, Tenaya, Sanofi-Pasteur, Dinaqor, Tremeau, CellProThera, Moderna, American Regent, Sarepta, Lexicon, Anacardio, Akros, PureHealth. ALS reports research grants from the National Heart Foundation of Australia Future Leader Fellowships (#101918 & 106025), NSW Health (Australia), Biotronik, RACE Oncology, Bristol Myer Squibb, Roche Diagnostics, and Vifor; and personal fees from Novartis, Bayer, Bristol Myer Squibb, AstraZeneca, and Boehringer Ingelheim. VS reports personal fees from Abbott Laboratories and Boston Scientific. SW reports personal fees from Novartis, AstraZeneca, and Bayer. MBL reports institutional research grants from Abbott, Boston Scientific, Edwards LifeSciences, and Medtronic. All other authors declare no competing interests., (Copyright © 2022 Elsevier Ltd. All rights reserved.)

Objectives: The aim of this registry was to evaluate the feasibility and safety of transcatheter tricuspid valve implantation (TTVI) in patients with extreme surgical risk., Background: Isolated tricuspid regurgitation (TR) surgery is associated with high in-hospital mortality., Methods: Thirty consecutive patients (mean age 75 ± 10 years; 56% women) from 10 institutions, with symptomatic functional TR, had institutional and notified body approval for compassionate use of the GATE TTVI system. Baseline, discharge, and 30-day follow-up echocardiographic data and procedural, in-hospital, and follow-up clinical outcomes were collected., Results: At baseline, all patients had multiple comorbidities, severe or greater TR, and reduced baseline right ventricular function. Technical success was achieved in 26 of 30 patients (87%). Device malpositioning occurred in 4 patients, with conversion to open heart surgery in 2 (5%). Of those who received the device, 100% had reductions in TR of ≥1, and 75% experienced reductions of ≥2 grades, resulting in 18 of 24 of patients (76%) with mild or less TR at discharge. All patients had mild or less central TR. There was continued improvement in TR grade between discharge and 30 days in 15 of 19 patients (79%). In-hospital mortality was 10%. At mean follow-up of 127 ± 82 days, 4 patients (13%) had died. Of patients alive at follow-up, 62% were in New York Heart Association functional class I or II, with no late device-related adverse events., Conclusions: Compassionate treatment of severe, symptomatic functional TR using a first-generation TTVI device is associated with significant reduction in TR and improvement in functional status with acceptable in-hospital mortality. Further studies are needed to determine the appropriate patient population and long-term outcomes with TTVI therapy., Competing Interests: Author Relationship With Industry Drs. Bartus and Rodés-Cabau are consultants for NaviGate Cardiac Structures. Dr. Hahn has received speaking fees from Boston Scientific, Baylis Medical, Edwards Lifesciences, and Medtronic; is an advisory board member for Abbott Structural, Edwards Lifesciences, Medtronic, NaviGate Cardiac Structures, and Philips Healthcare; holds equity in NaviGate Cardiac Structures; has received nonfinancial support from 3mensio; and is the chief scientific officer for the Echocardiography Core Laboratory at the Cardiovascular Research Foundation for multiple industry-sponsored trials, for which she receives no direct industry compensation. Dr. Latib is a consultant for Medtronic, Edwards Lifesciences, Abbott, and NeoChord. Dr. Navia is a consultant for NaviGate Cardiac Structures, with equity and royalties for inventor patents of the device. Dr. Sievert is a consultant for 4tech Cardio, Abbott, Ablative Solutions, Ancora Heart, Append Medical, Bavaria Medizin Technologie, BioVentrix, Boston Scientific, Carag, Cardiac Dimensions, Cardimed, CeloNova Biosciences, Comed, Contego, CVRx, Dinova, Edwards Lifesciences, Endologix, Hemoteq, Hangzhou Nuomao Medtech, Holistick Medical, Lifetech Scientific, Maquet Getinge Group, Medtronic, Mokita, Occlutech, ReCor Medical, Renal Guard, Terumo, Vascular Dynamics, Vectorious Medtech, Venock, Venus, and Vivasure Medical. All other authors have reported that they have no relationships relevant to the content of this paper to disclose., (Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Aims: Chronic total occlusion (CTO) has been linked to worse survival. While controversial and limited to observational data, successful CTO percutaneous coronary intervention (PCI) has been associated with improved left ventricular (LV) function and mortality. However, the role of CTO PCI prior to transcatheter aortic valve replacement (TAVR) is not clear. We sought to explore the prognostic impact of a pre-TAVR CTO on post-TAVR outcomes., Methods and Results: We retrospectively reviewed 783 consecutive TAVR cases performed at a single tertiary care medical center. Pre-TAVR angiograms were analyzed for the presence of a CTO. At the time of TAVR, 12.6% (n = 99) patients had a CTO. At one-year post-TAVR, there was no significant association between the presence of a CTO and death (14.2% vs 13.1%, p = 0.75), functional status, quality of life, or adverse events. There was also no difference in long-term survival (4.1 years vs 4.1 years, p = 0.55). LV ejection fraction was lower in the CTO group at baseline and one year (p < 0.01)., Conclusions: The presence of a CTO did not have any prognostic impact on mortality, change in LV function, or improvement in functional status and angina scores following TAVR in our cohort of elderly, high-risk patients. CTO before TAVR was associated with decreased ejection fraction at baseline and at one year., Competing Interests: Declaration of competing interest Dr. Malaisrie is a consultant for Edwards Lifesciences and Medtronic., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Background: Carotid artery stenosis is a risk factor for stroke after surgical aortic valve replacement, but it is unknown whether carotid and vertebral artery disease impacts the risk of stroke after transcatheter aortic valve replacement (TAVR)., Methods: We reviewed 294 consecutive cases of TAVR at a tertiary care medical centre. Thirty-one patients without preoperative carotid/vertebral duplex ultrasonograms were excluded. Carotid or vertebral artery disease was defined on the basis of >50% stenosis. Outcomes were stroke within 30 days after TAVR, 30-day mortality, and overall survival., Results: Fifty-one patients (19%) had at least 50% stenosis of a carotid or vertebral artery. The carotid and vertebral artery disease group had higher rates of coronary artery disease, previous coronary artery bypass surgery, and peripheral artery disease compared with the control group. Transfemoral access was less common in the carotid and vertebral artery disease group (55% vs 77%; P < 0.01). Stroke occurred in 6.8% of patients (n = 18) within 30 days after TAVR, but no patients in the carotid and vertebral artery disease group had a stroke. The presence of at least 50% stenosis of a carotid or vertebral artery was not predictive of stroke by logistic regression. There was no difference in 30-day mortality (10% vs 4%; P = 0.11) and overall survival (log-rank test P = 0.84) between the groups., Conclusions: The presence or absence of carotid or vertebral artery stenosis was not significantly related to the occurrence of stroke after TAVR. Routine screening for carotid and vertebral artery disease before TAVR does not appear justified., (Copyright © 2016 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved.)

Coronary blood flow is tightly autoregulated but is subject to epicardial and microvascular obstruction, primarily owing to coronary atherosclerosis. Because coronary flow limitation underlies ischemic heart disease, an understanding of coronary physiology is paramount. Measurement of coronary blood flow, once relegated to the research laboratory is now easily performed in the cardiac catheterization laboratory. In particular, the measurement of fractional flow reserve has been extensively studied and is an important adjunct to clinical decision making. Measurement of coronary flow informs clinicians of prognosis, guides revascularization therapy, and forms the basis of ongoing research in treatment of complex myocardial disease processes. Newer methods of assessing coronary flow measurements are undergoing validation for clinical use and should further enhance our ability to assess the importance of coronary flow in clinical disease., (Copyright © 2014 Elsevier B.V. All rights reserved.)

Background: The clinical course in primary pulmonary hypertension (PPH) is improved by calcium channel blocker therapy in those with a favorable hemodynamic response during a trial of high-dose oral nifedipine. Although trials of nifedipine are performed only in patients who demonstrate pulmonary vasodilator reserve to short-acting agents, this response does not predict the safety of nifedipine treatment, which can result in severe first-dose hypotension and death., Study Objectives: To identify echocardiographic parameters that predict first-dose nifedipine-induced hypotension in patients with PPH., Methods: The pretrial echocardiograms of 23 consecutive PPH patients (mean age, 42.3 +/- 13 years; 77% female) undergoing evaluation of pulmonary vasodilator reserve with nifedipine were analyzed. Patients were classified as those who suffered first-dose nifedipine hypotension (group 1) and those who did not (group 2). Echocardiographic measures of chamber size and septal geometry in the two groups were compared., Results: Five measures reflecting diminished left ventricular (LV) size and leftward ventricular septal bowing were found to be associated with nifedipine hypotension: LV transverse diameter in systole (LVDs; p = 0.007), LV transverse diameter in diastole (LVDd; p = 0.05), LV area in systole (LVAs; p = 0.009), LV area in diastole (LVAd; p = 0.03), the ratio of RV to LVAs (p = 0. 02), and leftward ventricular septal bowing (p = 0.01). The LV dimensions found to best predict nifedipine-induced hypotension were LVDs < 2.7 cm, LVDd < 4.0 cm, LVAs < 15.5 cm(2), and LVAd < 20.0 cm(2)., Conclusions: Readily available echocardiographic parameters in patients with PPH are predictive of nifedipine-induced hypotension, and can be used to select patients in whom a trial of nifedipine should be avoided.