The RISE Study: Retrospective Registry for the International Safety and Efficacy Results of Patent Foramen Ovale Closure with Figulla Flex Il PFO and UNI Occluders.

Background: Transcatheter closure of a patent foramen ovale (PFO) is performed in cryptogenic stroke and other conditions. Information is lacking for some devices. Methods: We aimed to evaluate the Figulla Flex II PFO Occluder (FFP) and Figulla Flex UNI Occluder (FFU) through a retrospective multi-center registry. Results: 527 patients were included. Mean age was 48.9 (±13.8) years. The procedure was under transthoracic, transesophageal or intracardiac echocardiography in 185 (35.1%), 193 (36.6%) and 149 (28.3%) cases, respectively, and under general anesthesia in 191 patients (36.2%). The FFP and FFU were used in 408 (77.4%) and 119 (22.6%) cases, respectively. The success rate was 99.1%. Median follow-up was 1.1 (0.5-2.5) years. A new atrial fibrillation/flutter within six months occurred in 14 (2.7%) cases, with no difference between devices. One device embolization in the pulmonary artery was identified two years post-procedure. Residual shunts occurred in 18 (6.9%) cases at 1 year, with TIA in three (16.6%) patients. Out of 437 patients with stroke/TIA, 260 (59%) were followed more than one year after closure. Median follow-up was 2.1 (1.17-3.1) years, with four recurrent strokes/TIA. Conclusions: The FFP and FFU devices are safe and effective for PFO closure, with very few atrial fibrillation/flutter and neurologic events, except in cases with a residual shunt.

Upfront triple therapy with parenteral prostanoid as a bridge to balloon pulmonary angioplasty in severe chronic thromboembolic pulmonary hypertension.

In patients with very severe CTEPH eligible for BPA, it is possible to achieve major haemodynamic improvement with upfront triple PH therapy including epoprostenol and then to perform angioplasties https://bit.ly/3vZZvib.

Assessment of the Objective Effect of Virtual Reality for Preoperative Anxiety in Interventional Cardiology.

The management of anxiety because of upcoming invasive coronary angiography (ICA) remains suboptimal. Previously published studies investigating the potential of virtual reality (VR) for the reduction of anxiety in ICA procedures used a subjective evaluation method. The purpose of this study was to determine whether the use of a VR program before ICA objectively decreases anxiety as assessed by the SD of normal to normal (SDNN). Lower SDNN is associated with worse anxiety. A total of 156 patients referred for ICA after a positive noninvasive test for coronary disease were included in the present randomized study. The interventional group benefited from the use of a VR mask in the transfer room before ICA, whereas the control group underwent the procedure as usual. In both groups, SDNN was measured before ICA. No statistical difference in SDNN was observed between the VR and control groups (45.5 ± 17.8 vs 50.6 ± 19.5, p = 0.12). The preoperative use of a VR mask for anxiolytic purposes in the setting of ICA did not result in a decrease in anxiety.

Pulmonary arterial compliance and exercise capacity after balloon pulmonary angioplasty in chronic thromboembolic pulmonary hypertension.

Objective: To determine whether changes in pulmonary vascular resistance (PVR) and changes in pulmonary artery compliance (C pa) are associated with changes in exercise capacity assessed either by changes in peak oxygen consumption (V'O2 ) or by changes in 6-min walk distance (6MWD) in patients with chronic thromboembolic pulmonary hypertension (CTEPH) undergoing balloon pulmonary angioplasty (BPA). Methods: Invasive haemodynamic parameters, peak V'O2 and 6MWD were measured within 24 h, before and after BPA (interval 3.1±2.4 months) in 34 CTEPH patients without significant cardiac and/or pulmonary comorbidities, of whom 24 received at least one pulmonary hypertension-specific treatment. C pa was calculated according to the pulse pressure method: C pa=((SV/PP)/1.76+0.1), where SV is the stroke volume and PP is the pulse pressure. The resistance-compliance (RC)-time of the pulmonary circulation was calculated as the PVR and C pa product. Results: After BPA, PVR decreased (562±234 versus 290±106 dyn·s·cm-5; p<0.001); C pa increased (0.90±0.36 versus 1.63±0.65 mL·mmHg-1; p<0.001); but RC-time did not change (0.325±0.069 versus 0.321±0.083 s; p=0.75). There were improvements in peak V'O2 (1.11±0.35 versus 1.30±0.33 L·min-1; p<0.001) and in 6MWD (393±119 versus 432±100 m; p<0.001). After adjustment for age, height, weight and gender, changes in exercise capacity, assessed either by peak V'O2 or 6MWD, were significantly associated with changes in PVR, but not with changes in C pa. Conclusions: Contrary to what has been reported in CTEPH patients undergoing pulmonary endarterectomy, in CTEPH patients undergoing BPA, changes in exercise capacity were not associated with changes in C pa.

Prognostic significance of severe coronary microvascular dysfunction post-PCI in patients with STEMI: A systematic review and meta-analysis.

Coronary microvascular dysfunction (CMVD) is common and associated with poorer outcomes in patients with ST Segment Elevation Myocardial Infarction (STEMI). The index of microcirculatory resistance (IMR) and the index of hyperemic microvascular resistance (HMR) are both invasive indexes of microvascular resistance proposed for the diagnosis of severe CMVD after primary percutaneous coronary intervention (pPCI). However, these indexes are not routinely assessed in STEMI patients. Our main objective was to clarify the association between IMR or HMR and long-term major adverse cardiovascular events (MACE), through a systematic review and meta-analysis of observational studies. We searched Medline, PubMed, and Google Scholar for studies published in English until December 2020. The primary outcome was a composite of cardiovascular death, non-cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, and rehospitalization for heart failure occurring after at least 6 months following CMVD assessment. We identified 6 studies, reporting outcomes in 1094 patients (mean age 59.7 ± 11.4 years; 18.2% of patients were women) followed-up from 6 months to 7 years. Severe CMVD, defined as IMR > 40 mmHg or HMR > 3mmHg/cm/sec was associated with MACE with a pooled HR of 3.42 [2.45; 4.79]. Severe CMVD is associated with an increased risk of long-term adverse cardiovascular events in patients with STEMI. Our results suggest that IMR and HMR are useful for the early identification of severe CMVD in patients with STEMI after PCI, and represent powerful prognostic assessments as well as new therapeutic targets for clinical intervention.

Balloon pulmonary angioplasty for chronic thromboembolic pulmonary hypertension: Evaluation of haemodynamic effects, complication rates and radiation exposure over time.

BACKGROUND: In patients undergoing balloon pulmonary angioplasty (BPA) for inoperable chronic thromboembolic pulmonary hypertension (CTEPH), single-centre series from expert centres have recognized a learning curve for the magnitude of haemodynamic benefits. OBJECTIVE: To report our 7-year experience with BPA, focusing on haemodynamic effects, complication rates and radiation exposure over time. METHODS: Patients with CTEPH who were treated with BPA between May 2013 and February 2020 were analysed during the 'initial period' versus the 'recent period' (split date: March 2017). RESULTS: Among 192 patients who underwent at least one BPA procedure, 156 were included in the safety/radiation analysis and 119 were included in the efficacy analysis. During the 'recent period' versus the 'initial period', the median [interquartile range] number of procedures per patient was higher (4.5 [4.0-6.0] vs. 4.0 [3.0-4.0]; P=0.03), as was the number of dilated vessels per procedure (4.0 [3.5-5.0] vs. 3.5 [3.0-4.0]; P=0.002). Changes in haemodynamic parameters were also greater (mean pulmonary artery pressure: -22% [-31% to -14%] vs. -37% [-44% to -29%]; P=0.001; pulmonary vascular resistance: -38% [-51% to -8%] vs. -53% [-69% to -33%]; P=0.002); complication rates were similar (5.7% vs. 9.3% of procedures; P=0.38); and radiation exposure was lower (effective dose per patient: 43.9 [31.6-66.5] vs. 67.8 [47.9-101.9] mSv; P<0.001). CONCLUSION: Our analysis is consistent with a learning curve for the magnitude of haemodynamic improvements. The complication rate was low and did not change over time, but radiation exposure decreased.

Impact of a micro-net mesh technology covering stent on coronary microvascular dysfunction in patients with high thrombus burden.

BACKGROUND: Highly thrombotic coronary lesions continue to be a serious and clinically significant problem that is not effectively and completely addressed by current technology. OBJECTIVES: We aimed to investigate whether a micro-net mesh (MNM) technology covering stent could preserve the index of microcirculatory resistance (IMR) after percutaneous coronary intervention (PCI) in patients with high thrombus burden. METHODS AND RESULTS: Fifty-two patients with non-ST elevation myocardial infarction or ST Elevation Myocardial Infarction and high thrombus burden (TIMI thrombus grade ≥ 3) were randomized into two groups, PCI with a MNM covering stent (MNM group, n = 25) and PCI with any commercially available stent (DES group, n = 27). As the primary endpoint, IMR was measured immediately after PCI using a pressure-temperature sensor-tipped coronary wire. The secondary endpoint was left ventricular ejection fraction (LVEF) at 6 months of follow-up. The IMR in the MNM group was significantly lower in comparison to the DES group (33.2 [21.3, 48.9] vs. 57.2 [39.9, 98.0], p = 0.005). No significant differences were observed in baseline LVEF (54.5 ± 10.2% vs. 53.1 ± 6.87%, p = .57), while LVEF was significantly improved at follow-up in the MNM group (61.1 ± 7.1% vs. 53.9 ± 6.35%, p = .0001). CONCLUSION: MNM technology significantly improved coronary microvascular dysfunction after PCI in patient with acute coronary syndrome and appears as a useful technological option for thrombus management.

Coronary Physiology: Delivering Precision Medicine?

Coronary physiological assessment is now widely used to assess epicardial coronary lesions in cath lab. Based on clinical evidence, fractional flow reserve (FFR) is the gold standard method to select whether epicardial coronary lesions need revascularization. While additional epicardial indexes, such as instantaneous wave-free ratio (iFR), are also used for revascularization decision-making, several indexes are now also available to explore the coronary microcirculation. Therefore, coronary physiological assessment now allows to explore the entire coronary tree and offer the potential of precision medicine for patients affected by coronary artery disease (CAD). This paper will provide review of the epicardial and microvascular indexes available for the assessment of coronary physiology. More specifically, the already demonstrated contributions of these indexes in the management of CAD and the role they could play in precision medicine will be reviewed with special emphasis on chronic coronary syndrome.

Sex differences in coronary artery lesions and in-hospital outcomes for patients with ST-segment elevation myocardial infarction under the age of 45.

OBJECTIVE: We aimed to compare baseline characteristics, coronary angiogram findings, and in-hospital outcomes between female and male patients with ST-segment elevation myocardial infarction (STEMI) under the age of 45 years. BACKGROUND: Although sex differences in risk factor profile have been documented for young patients with STEMI, limited data exist on the prevalence of spontaneous coronary artery dissection in these patients. METHODS: As part of an ongoing hospital-based registry of suspected STEMI, we analyzed the original data for 51 women under the age of 45 years matched with 93 men of similar age who underwent coronary angiography at two percutaneous coronary intervention centers, between January 2003 and December 2012. Two interventional cardiologists independently reviewed coronary angiograms for all patients. RESULTS: The mean age for all patients was 39 years (range, 24-44) and the overall prevalence of cigarette smoking, dyslipidemia, hypertension, and diabetes mellitus were 70, 32, 13, and 4%, respectively. Young women were more likely to present with spontaneous coronary artery dissection (22 vs. 3%, p = .003) and more of them experienced reinfarction during the hospital course (15 vs. 1%, p = .01). The in-hospital mortality rate was 2% for both sexes. CONCLUSIONS: Spontaneous coronary artery dissection is an important cause of myocardial infarction in young female adults, accounting for 22% (95% confidence interval, 11-35%) of women with STEMI under the age of 45 years. The true prevalence of spontaneous coronary artery dissection might even be underestimated, because of the limited availability of advanced imaging techniques at the time of our study.

SPECT myocardial ischemia in the absence of obstructive CAD: Contribution of the invasive assessment of microvascular dysfunction.

Coronary microvascular dysfunction has recently emerged as a major independent prognostic factor and can be invasively assessed by coronary flow reserve (CFR) and the index of microvascular resistance (IMR). The incremental prognostic value of myocardial ischemia from SPECT myocardial perfusion imaging (MPI) over clinical characteristics, cardiac risk factors, and stress test data for the prediction of hard cardiac events (myocardial infarction and cardiac death) has been well demonstrated over the last two decades regardless of the absence or presence of epicardial CAD. Recently developed semi-conductor, cardiac-dedicated cameras allow for decreased acquisition times and systematic procubitus and decubitus acquisitions thereby limiting the occurrence of false positives historically attributable to artefactual motion, attenuation, and digestive artifacts. It is therefore likely that pathophysiological causes rather than acquisition artifacts might underlie SPECT perfusion abnormalities. Here, we report four representative examples of patients presenting with ischemia in the setting of no obstructive CAD and normal fractional flow reserve together with elevated IMR and low CFR. The results indicate that ischemia from SPECT MPI could result from microvascular dysfunction in patients without obstructive CAD and should be considered as a prognostic factor for hard cardiac events.

Antiplatelet Drug Regimen in Patients With Stent Thrombosis　- Insights From the PESTO French Optical Coherence Tomography Registry.

BACKGROUND: Stent thrombosis (ST) may be triggered by different phenomena, including underlying device abnormalities and modification of the antiplatelet therapy (APT) regimen. This work investigated the characteristics of APT regimens and their relationships with ST mechanisms among a large cohort of patients evaluated by optical coherence tomography (OCT).Methods and Results:A prospective multicenter registry was screened for patients with confirmed ST. OCT was performed after the initial intervention to the culprit lesion. ST was classified as acute (AST), subacute (SAST), late (LST) and very late (VLST). OCT records were analyzed in a central core laboratory. A total of 120 patients (median age 62 years, 89% male) were included in the study. VLST was the clinical presentation in 75%, LST in 6% and SAST+AST in 19% of the patients. Single APT (SAPT) was given in 61%, double APT (DAPT) in 27% and no APT in 12% of the cases at the time of the ST. A recent (≤15 days) APT modification was reported in 22% of the patients. An underlying mechanical abnormality was identified by OCT in 96.7% of the cases. Ruptured neoatherosclerotic lesions were significantly more frequent in patients without APT compared with the others. CONCLUSIONS: ST mostly occurs in patients receiving DAPT or SAPT. Any underlying mechanical abnormality of ST can be involved, irrespective of the APT regimen.

Stress thallium-201/rest technetium-99m sequential dual-isotope high-speed myocardial perfusion imaging validation versus invasive coronary angiography.

BACKGROUND: Recent advances in nuclear myocardial perfusion imaging (MPI) have made it possible to develop a dual-isotope protocol for high-speed acquisition with image quality and radiation delivery comparable to that obtained with conventional single isotope protocols. So far, no study has compared dual-isotope high-speed MPI to invasive coronary angiography (ICA) in a large cohort using a Cadmium-zinc-telluride SPECT system. METHODS: Over a 1-year period (May 2011 to April 2012), 1366 patients underwent dual-isotope high-speed MPI. Patients with ICA within 3 months after dual-isotope high-speed MPI were included together with patients with a low likelihood of coronary artery disease (CAD) in order to assess normalcy rate. Global summed stress score (SSS) and summed rest score (SRS) were calculated, and ICA results were analyzed independently. The main end point was a patient-based assessment of the diagnostic performance of dual-isotope high-speed MPI in detecting or ruling out significant CAD (>70% reduction in lumen diameter). RESULTS: Inclusion criteria were fulfilled for 214 patients (143 men; age 60 ± 14 years; ICA, n = 104; low likelihood for CAD, n = 110). An exercise stress test was performed in 62% of patients and a pharmacological stress test was performed with either dipyridamole (32%) or dobutamine (6%). Average examination duration was 22.4 ± 4.5 minutes. Mean SSS, SRS, and SDS were 8.0 ± 4.9, 3.1 ± 4.3, and 5.0 ± 3.2, respectively. Prevalence of angiographic CAD was 75%. ICA detected stenosis in the left main trunk, left anterior descending artery, left circumflex artery, and right coronary artery in 4, 33, 31, and 42 patients, respectively. Sensitivity of dual-isotope high-speed MPI was 94%, normalcy rate was 92%, and accuracy was 83% for detecting CAD. CONCLUSION: Dual-isotope high-speed MPI is reliable at detecting or ruling out CAD. NCT01785589.