Coronary angiography and percutaneous coronary intervention after transcatheter aortic valve replacement: Feasibility in clinical practice.

INTRODUCTION AND OBJECTIVE: Coronary artery disease is highly prevalent among patients with severe aortic stenosis who undergo transcatheter aortic valve replacement (TAVR). As indications for TAVR are now expanding to younger and lower-risk patients, the need for coronary angiography (CA) and percutaneous coronary intervention (PCI) during their lifetime is expected to increase. The objective of our study was to assess the need for CA and the feasibility of re-engaging the coronary ostia after TAVR. METHODS: We performed a retrospective analysis of 853 consecutive patients undergoing TAVR between August 2007 and December 2020. Patients who needed CA after TAVR were selected. The primary endpoint was the rate of successful coronary ostia cannulation after TAVR. RESULTS: Of a total of 31 CAs in 28 patients (3.5% of 810 patients analyzed: 57% male, age 77.8±7.0 years) performed after TAVR, 28 (90%) met the primary endpoint and in three cannulation was semi-selective. All failed selective coronary ostia cannulations occurred in patients with a self-expanding valve. Sixteen (52%) also had indication for PCI, which was successfully performed in all. The main indication for CA was non-ST-elevation acute coronary syndrome (35%, n=11). Two cases of primary PCI occurred without delay. There were no complications reported during or after the procedure. CONCLUSION: Although CA was rarely needed in patients after TAVR, selective diagnostic CA was possible in the overwhelming majority of patients. PCI was performed successfully in all cases, without complications.

Impact of the use of cusp-overlap projection on the incidence of permanent pacemaker implantation post-transcatheter aortic valve implantation with self-expanding valves.

INTRODUCTION: Current rates of permanent pacemaker implantation (PPMI) after transcatheter aortic valve implantation (TAVI) range between 3.4% and 25.9%. PPMI is associated with a worse prognosis. A lower valve implantation depth is associated with an increased risk of conduction disturbances. Theoretically, cusp-overlap projection (COP) has the potential to enable higher valve deployment. OBJECTIVE: To compare the 30-day PPMI incidence post-TAVI using self-expanding valves according to the fluoroscopic guidance technique. METHODS: This retrospective single-center study assessed consecutive patients undergoing TAVI with CoreValve™ valves between April 2019 and November 2021, grouped according to the fluoroscopic guidance technique (COP vs. coplanar implantation technique [CIT]). RESULTS: A total of 122 patients were included, predominantly women (52.5%), with a mean age of 81.6±5.5 years. COP was used in 49.2% of the sample. The CIT group had a significantly higher prevalence of previous beta-blocker use (p<0.01), lower baseline left ventricular ejection fraction (p=0.04) and a higher EuroSCORE II (p=0.02). The 30-day PPMI rate was 27.9% (n=34), with no significant difference between the COP and CIT groups (26.7% vs. 29.0%, p=0.77). Complete atrioventricular block was the main cause (38.5%). Likewise, mean fluoroscopy time (p=0.14) and contrast volume (p=0.35) used were similar between the two groups. Radiation dose was lower in the COP group (p=0.02). There was no significant difference between post-TAVI grades III and IV aortic valve regurgitation (p=0.27) and there were no cases of periprocedural acute coronary occlusion. CONCLUSIONS: This study shows that the COP technique, although safe and not associated with increased complexity, did not significantly reduce the 30-day PPMI rate compared to the traditional CIT view.

Serum and salivary cytokines in patients with oral lichen planus treated with Photobiomodulation.

OBJECTIVES: To evaluate the serum and salivary levels of IL-1ß, IL-6, IL-17A, TNF-α, IL-4, and IL-10 in patients with oral lichen planus (OLP) treated with Photobiomodulation (PBM) and clobetasol propionate 0.05%. MATERIAL AND METHODS: Thirty-four OLP patients were randomized into two groups: Control (clobetasol propionate 0.05%) and PBM (660 nm, 100 mW, 177 J/cm2 , 5 s, 0.5 J per point). Serum and saliva were collected at baseline and at the end of treatment (after 30 days) and evaluated using ELISA. The cytokine results were correlated with pain, clinical subtypes, and clinical scores of OLP. RESULTS: IL-1ß, IL-6, IL-17A, TNF-α, and IL-4 levels were higher in saliva in relation to serum. IL-1ß was the most concentrated cytokine in saliva, and a positive correlation with the severity of OLP was noticed. After treatment with corticosteroid, IL-1ß in saliva decreased significantly. No modulation of all cytokines was observed after PBM. CONCLUSION: IL-1ß appears to be an important cytokine involved in OLP pathogenesis. In addition, the mechanisms of action of PBM do not seem to be linked to the modulation of pro or anti-inflammatory cytokines at the end of treatment. It is possible that this events occurred early during treatment.

Impact of the COVID-19 pandemic on percutaneous coronary interventions in Portugal.

INTRODUCTION: The COVID-19 pandemic has imposed an unprecedented burden on healthcare systems worldwide, changing the profile of interventional cardiology activity. OBJECTIVES: To quantify and compare the number of percutaneous coronary interventions (PCIs) performed for acute and chronic coronary syndromes during the first COVID-19 outbreak with the corresponding period in previous years. METHODS: Data on PCI from the prospective multicenter Portuguese Registry on Interventional Cardiology (RNCI) were used to analyze changes in PCI for ST-elevation myocardial infarction (STEMI), non-ST-elevation acute coronary syndromes (NSTE-ACS) and chronic coronary syndromes (CCS). The number of PCIs performed during the initial period of the COVID-19 outbreak in Portugal, from March 1 to May 2, 2020, was compared with the mean frequency of PCIs performed during the corresponding period in the previous three years (2017-2019). RESULTS: The total number of PCIs procedures was significantly decreased during the initial COVID-19 outbreak in Portugal (-36%, p<0.001). The reduction in PCI procedures for STEMI, NSTE-ACS and CCS was, respectively, -25% (p<0.019), -20% (p<0.068) and -59% (p<0.001). CONCLUSIONS: Compared with the corresponding period in the previous three years, the number of PCI procedures performed for STEMI and CCS decreased markedly during the first wave of the COVID-19 pandemic in Portugal.

Major Bleeding Predictors in Patients with Left Atrial Appendage Closure: The Iberian Registry II.

INTRODUCTION AND OBJECTIVE: Major bleeding events in patients undergoing left atrial appendage closure (LAAC) range from 2.2 to 10.3 per 100 patient-years in different series. This study aimed to clarify the bleeding predictive factors that could influence these differences. METHODS: LAAC was performed in 598 patients from the Iberian Registry II (1093 patient-years; median, 75.4 years). We conducted a multivariate analysis to identify predictive risk factors for major bleeding events. The occurrence of thromboembolic and bleeding events was compared to rates expected from CHA2DS2-VASc (congestive heart failure, hypertension, age, diabetes, stroke history, vascular disease, sex) and HAS-BLED (hypertension, abnormal renal and liver function, stroke, bleeding, labile INR, elderly, drugs or alcohol) scores. RESULTS: Cox regression analysis revealed that age ≥75 years (HR: 2.5; 95% CI: 1.3 to 4.8; p = 0.004) and a history of gastrointestinal bleeding (GIB) (HR: 2.1; 95% CI: 1.1 to 3.9; p = 0.020) were two factors independently associated with major bleeding during follow-up. Patients aged <75 or ≥75 years had median CHA2DS2-VASc scores of 4 (IQR: 2) and 5 (IQR: 2), respectively (p < 0.001) and HAS-BLED scores were 3 (IQR: 1) and 3 (IQR: 1) for each group (p = 0.007). Events presented as follow-up adjusted rates according to age groups were stroke (1.2% vs. 2.9%; HR: 2.4, p = 0.12) and major bleeding (3.7 vs. 9.0 per 100 patient-years; HR: 2.4, p = 0.002). Expected major bleedings according to HAS-BLED scores were 6.2% vs. 6.6%, respectively. In patients with GIB history, major bleeding events were 6.1% patient-years (HAS-BLED score was 3.8 ± 1.1) compared to 2.7% patients-year in patients with no previous GIB history (HAS-BLED score was 3.4 ± 1.2; p = 0.029). CONCLUSIONS: In this high-risk population, GIB history and age ≥75 years are the main predictors of major bleeding events after LAAC, especially during the first year. Age seems to have a greater influence on major bleeding events than on thromboembolic risk in these patients.

Same-day discharge after elective percutaneous coronary intervention: A single center experience.

INTRODUCTION AND OBJECTIVES: Elective percutaneous coronary intervention (PCI) has become an increasingly safe procedure. However, same day discharge (SDD) has yet to become standard practice. Our aim is to characterize the patients who underwent elective PCI and compare outcomes between the overnight stay (ONS) patient group and the group that was discharged on the same day at 24 hours and at 30 days. METHODS: One-year registry of patients who underwent an elective PCI. The possibility of SDD was established by the operator. Appropriate candidates were discharged at least four hours after the end of the intervention. The primary endpoints were defined as: Major adverse cardiac and cerebrovascular events (MACCE) - death, myocardial infarction (MI) stroke or transient ischemic attack (TIA), non-planned re-intervention - and vascular complications. Secondary endpoints were any unplanned hospital visit, readmission and re-catheterization. RESULTS: We performed 155 elective PCIs. One patient was admitted to the coronary care unit; 111 patients stayed overnight (ONS Group); 43 patients were discharged the same day (SDD Group). Three patients had early (<4 hours) post procedure complications: two TIAs and one vascular access site complication. There were no MACCE between four and 24 hours, nor at 30 days. At 24 hours, two patients from the SDD group had unplanned visits. Between one and 30 days, more patients from the SDD group had unplanned visits (9.3% vs. 0.9%. p=0.02). One patient from the ONS group had a recatherization. There were no readmissions or reinterventions. CONCLUSION: Same day discharge of selected patients who undergo elective PCIs is feasible and safe.

Usefulness of Routine Fractional Flow Reserve for Clinical Management of Coronary Artery Disease in Patients With Diabetes.

Importance: Approximately one-third of patients considered for coronary revascularization have diabetes, which is a major determinant of clinical outcomes, often influencing the choice of the revascularization strategy. The usefulness of fractional flow reserve (FFR) to guide treatment in this population is understudied and has been questioned. Objective: To evaluate the usefulness and rate of major adverse cardiovascular events (MACE) of integrating FFR in management decisions for patients with diabetes who undergo coronary angiography. Design, Setting, and Participants: This cross-sectional study used data from the PRIME-FFR study derived from the merger of the POST-IT study (Portuguese Study on the Evaluation of FFR-Guided Treatment of Coronary Disease [March 2012-November 2013]) and R3F study (French Study of FFR Integrated Multicenter Registries Implementation of FFR in Routine Practice [October 2008-June 2010]), 2 prospective multicenter registries that shared a common design. A population of all-comers for whom angiography disclosed ambiguous lesions was analyzed for rates, patterns, and outcomes associated with management reclassification, including revascularization deferral, in patients with vs without diabetes. Data analysis was performed from June to August 2018. Main Outcomes and Measures: Death from any cause, myocardial infarction, or unplanned revascularization (MACE) at 1 year. Results: Among 1983 patients (1503 [77%] male; mean [SD] age, 65 [10] years), 701 had diabetes, and FFR was performed for 1.4 lesions per patient (58.2% of lesions in the left anterior descending artery; mean [SD] stenosis, 56% [11%]; mean [SD] FFR, 0.81 [0.01]). Reclassification by FFR was high and similar in patients with and without diabetes (41.2% vs 37.5%, P = .13), but reclassification from medical treatment to revascularization was more frequent in the former (142 of 342 [41.5%] vs 230 of 730 [31.5%], P = .001). There was no statistical difference between the 1-year rates of MACE in reclassified (9.7%) and nonreclassified patients (12.0%) (P = .37). Among patients with diabetes, FFR-based deferral identified patients with a lower risk of MACE at 12 months (25 of 296 [8.4%]) compared with those undergoing revascularization (47 of 257 [13.1%]) (P = .04), and the rate was of the same magnitude of the observed rate among deferred patients without diabetes (7.9%, P = .87). Status of insulin treatment had no association with outcomes. Patients (6.6% of the population) in whom FFR was disregarded had the highest MACE rates regardless of diabetes status. Conclusions and Relevance: Routine integration of FFR for the management of coronary artery disease in patients with diabetes may be associated with a high rate of treatment reclassification. Management strategies guided by FFR, including revascularization deferral, may be useful for patients with diabetes.

Extracorporeal membrane oxygenation in circulatory and respiratory failure - A single-center experience. / Oxigenação por membrana extracorporal na falência circulatória e respiratória ­ experiência de um centro.

INTRODUCTION: Extracorporeal membrane oxygenation (ECMO) provides mechanical pulmonary and circulatory support for patients with shock refractory to conventional medical therapy. In this study we aim to describe the indications, clinical characteristics, complications and mortality associated with use of ECMO in a single tertiary hospital. METHODS: We conducted a retrospective observational cohort study of all patients supported with ECMO in two different intensive care units (general and cardiac), from the first patient cannulated in April 2011 up to October 2016. RESULTS: Overall, 48 patients underwent ECMO: 29 venoarterial ECMO (VA-ECMO) and 19 venovenous ECMO (VV-ECMO). In VA-ECMO, acute myocardial infarction was the main reason for placement. The most frequent complication was lower limb ischemia and the most common organ dysfunction was acute renal failure. In VV-ECMO, acute respiratory distress syndrome after viral infection was the leading reason for device placement. Access site bleeding and hematologic dysfunction were the most prevalent complication and organ dysfunction, respectively. Almost 70% of ECMO episodes were successfully weaned in each group. Survival to discharge was 37.9% for VA-ECMO and 63.2% for VV-ECMO. In VA-ECMO, the number of inotropic agents was a predictor of mortality. CONCLUSION: Patients with respiratory indications for ECMO experienced better survival than cardiac patients. The need for more inotropic drugs was a predictor of mortality in VA-ECMO. This is the first published record of the overall experience with ECMO in a Portuguese tertiary hospital.

Percutaneous closure of periprosthetic paravalvular leaks: A viable alternative to surgery?

INTRODUCTION AND OBJECTIVES: Paravalvular leak (PVL) is a possible complication after prosthetic valve implantation. PVL can cause significant symptoms of congestive heart failure and/or hemolysis. Medical therapy is palliative and reoperation has a high mortality rate. Percutaneous transcatheter closure is a promising alternative for symptomatic patients at high surgical risk. We aim to review the efficacy and safety of percutaneous PVL closure in a consecutive series of patients referred to our center. METHODS: We performed a retrospective analysis of clinical and technical procedural data of patients referred to our center for percutaneous PVL closure between January 2009 and November 2015. RESULTS: Twenty procedures were performed in 18 patients under general anesthesia and under transesophageal echocardiographic and radiographic guidance. Fourteen mitral PVLs were successfully treated in 13 patients and one aortic PVL in one patient. Most (eight) of the PVLs closed were in mitral bioprostheses. Two patients underwent a second intervention, which was technically successful in one. Technical success was achieved in 15 (75%) of the procedures. At discharge, median NYHA functional class decreased by one and hemolytic anemia decreased from seven cases (38.9%) to two (11.1%). Two patients had minor bleeding at the femoral vascular access site. Survival rates at six, 12 and 24 months were 77.8%, 77.8% and 61.1%, respectively. CONCLUSIONS: In our experience, percutaneous PVL closure was overall effective and safe. The procedure is complex and a second intervention may be necessary. Percutaneous PVL closure may be a feasible alternative for selected symptomatic patients at high surgical risk refractory to medical therapy.

Impact of Routine Fractional Flow Reserve on Management Decision and 1-Year Clinical Outcome of Patients With Acute Coronary Syndromes: PRIME-FFR (Insights From the POST-IT [Portuguese Study on the Evaluation of FFR-Guided Treatment of Coronary Disease] and R3F [French FFR Registry] Integrated Multicenter Registries - Implementation of FFR [Fractional Flow Reserve] in Routine Practice).

BACKGROUND: Fractional flow reserve (FFR) is not firmly established as a guide to treatment in patients with acute coronary syndromes (ACS). Primary goals were to evaluate the impact of integrating FFR on management decisions and on clinical outcome of patients with ACS undergoing coronary angiography, as compared with patients with stable coronary artery disease. METHODS AND RESULTS: R3F (French FFR Registry) and POST-IT (Portuguese Study on the Evaluation of FFR-Guided Treatment of Coronary Disease), sharing a common design, were pooled as PRIME-FFR (Insights From the POST-IT and R3F Integrated Multicenter Registries - Implementation of FFR in Routine Practice). Investigators prospectively defined management strategy based on angiography before performing FFR. Final decision after FFR and 1-year clinical outcome were recorded. From 1983 patients, in whom FFR was prospectively used to guide treatment, 533 sustained ACS (excluding acute ST-segment-elevation myocardial infarction). In ACS, FFR was performed in 1.4 lesions per patient, mostly in left anterior descending (58%), with a mean percent stenosis of 58±12% and a mean FFR of 0.82±0.09. In patients with ACS, reclassification by FFR was high and similar to those with non-ACS (38% versus 39%; P=NS). The pattern of reclassification was different, however, with less patients with ACS reclassified from revascularization to medical treatment compared with those with non-ACS (P=0.01). In ACS, 1-year outcome of patients reclassified based on FFR (FFR against angiography) was as good as that of nonreclassified patients (FFR concordant with angiography), with no difference in major cardiovascular event (8.0% versus 11.6%; P=0.20) or symptoms (92.3% versus 94.8% angina free; P=0.25). Moreover, FFR-based deferral to medical treatment was as safe in patients with ACS as in patients with non-ACS (major cardiovascular event, 8.0% versus 8.5%; P=0.83; revascularization, 3.8% versus 5.9%; P=0.24; and freedom from angina, 93.6% versus 90.2%; P=0.35). These findings were confirmed in ACS explored at the culprit lesion. In patients (6%) in whom the information derived from FFR was disregarded, a dire outcome was observed. CONCLUSIONS: Routine integration of FFR into the decision-making process of ACS patients with obstructive coronary artery disease is associated with a high reclassification rate of treatment (38%). A management strategy guided by FFR, divergent from that suggested by angiography, including revascularization deferral, is safe in ACS.

Mechanism of Supplemental Activator and Reducing Agent Atom Transfer Radical Polymerization Mediated by Inorganic Sulfites: Experimental Measurements and Kinetic Simulations.

The mechanism of atom transfer radical polymerization (ATRP) mediated by sodium dithionite (Na2S2O4), with CuIIBr2/Me6TREN as catalyst (Me6TREN: tris[2-(dimethylamino)ethyl]amine)) in ethanol/water mixtures, was investigated experimentally and by kinetic simulations. A kinetic model was proposed and the rate coefficients of the relevant reactions were measured. The kinetic model was validated by the agreement between experimental and simulated results. The results indicated that the polymerization followed the SARA ATRP mechanism, with a SO2•- radical anion derived from Na2S2O4, acting as both supplemental activator (SA) of alkyl halides and reducing agent (RA) for CuII/L to regenerate the main activator CuI/L. This is similar to the reversible-deactivation radical polymerization (RDRP) procedure conducted in the presence of Cu0. The electron transfer from SO2•-, to either CuIIBr2/Me6TREN or R-Br initiator, appears to follow an outer sphere electron transfer (OSET) process. The developed kinetic model was used to study the influence of targeted degree of polymerization, concentration of CuIIBr2/Me6TREN and solubility of Na2S2O4 on the level of polymerization control. The presence of small amounts of water in the polymerization mixtures slightly increased the reactivity of the CuI/L complex, but markedly increased the reactivity of sulfites.

Impact of Routine Fractional Flow Reserve Evaluation During Coronary Angiography on Management Strategy and Clinical Outcome: One-Year Results of the POST-IT.

BACKGROUND: Penetration of fractional flow reserve (FFR) in clinical practice varies extensively, and the applicability of results from randomized trials is understudied. We describe the extent to which the information gained from routine FFR affects patient management strategy and clinical outcome. METHODS AND RESULTS: Nonselected patients undergoing coronary angiography, in which at least 1 lesion was interrogated by FFR, were prospectively enrolled in a multicenter registry. FFR-driven change in management strategy (medical therapy, revascularization, or additional stress imaging) was assessed per-lesion and per-patient, and the agreement between final and initial strategies was recorded. Cardiovascular death, myocardial infarction, or unplanned revascularization (MACE) at 1 year was recorded. A total of 1293 lesions were evaluated in 918 patients (mean FFR, 0.81±0.1). Management plan changed in 406 patients (44.2%) and 584 lesions (45.2%). One-year MACE was 6.9%; patients in whom all lesions were deferred had a lower MACE rate (5.3%) than those with at least 1 lesion revascularized (7.3%) or left untreated despite FFR≤0.80 (13.6%; log-rank P=0.014). At the lesion level, deferral of those with an FFR≤0.80 was associated with a 3.1-fold increase in the hazard of cardiovascular death/myocardial infarction/target lesion revascularization (P=0.012). Independent predictors of target lesion revascularization in the deferred lesions were proximal location of the lesion, B2/C type and FFR. CONCLUSIONS: Routine FFR assessment of coronary lesions safely changes management strategy in almost half of the cases. Also, it accurately identifies patients and lesions with a low likelihood of events, in which revascularization can be safely deferred, as opposed to those at high risk when ischemic lesions are left untreated, thus confirming results from randomized trials. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01835808.

CT myocardial perfusion and coronary CT angiography: Influence of coronary calcium on a stress-rest protocol.

BACKGROUND: High amounts of coronary artery calcium limit image quality and diagnostic accuracy of multidetector computed tomography (MDCT) angiography (CTA) regarding the assessment of obstructive coronary artery disease (CAD). CT myocardial perfusion imaging may represent an opportunity to overcome this limitation. OBJECTIVE: To explore the additive value of CT myocardial perfusion to CTA depending on the patient's calcium score and in comparison to the reference standard of invasive coronary angiography plus fractional flow reserve (FFR) measurement. METHODS: Symptomatic patients with intermediate pretest probability of CAD were prospectively recruited and underwent both cardiac MDCT (64-slice scanner, retrospectively-gated stress-rest protocol) and invasive coronary angiography including FFR assessment. We defined hemodynamically significant CAD by the presence of occlusive or subocclusive (99%) stenosis, >50% stenosis in left main or FFR≤0.80. Stress CT myocardial perfusion imaging was performed in all patients in addition to CTA. The additive value of CT myocardial perfusion to rule in or rule out the presence of hemodynamically relevant stenosis on a per-patient basis was assessed and analyzed relative to the patient's calcium score. RESULTS: 95 patients were included in the analysis (62 ± 8.2 years, 68%males). Hemodynamically significant CAD was present in 42 patients. Sixty-four patients had a fully evaluable CTA examination. Per-patient, CTA alone had a sensitivity, specificity and AUC of 100%, 59% and 0.79 respectively (77% patients correctly classified). Adding CT myocardial perfusion to evaluate uninterpretable vessel territories in CTA in 66 patients with a calcium score>100 yielded a sensitivity of 88%, a specificity of 74% and an AUC of 0.81 (81% patients correctly classified), and in 52 patients with a calcium score>400 sensitivity was 91%, specificity 70%, and AUC 0.80 (82% patients correctly classified, p = 0.733 versus using perfusion imaging in all patients). CONCLUSIONS: From a pragmatic standpoint, limiting the use of CT perfusion to individuals with a calcium score above 400 might be a feasible strategy to optimize the diagnostic accuracy of CT imaging for diagnosis of obstructive CAD.

Cardiogenic shock induced by Takotsubo cardiomyopathy: A new therapeutic option.

Takotsubo cardiomyopathy (TC) is characterized by the sudden onset of reversible left ventricular dysfunction, with a presentation similar to that of an acute coronary syndrome. Although cardiogenic shock is a rare occurrence in TC, if it does occur it may require the use of a left ventricular assist device. We report the use of extracorporeal life support (ECLS) in a patient with TC and refractory cardiogenic shock. With ECLS it was possible to reduce inotropic support, and a normal left ventricular ejection fraction was documented by echocardiography on day 2. This is, to our knowledge, the first reported case of TC with refractory cardiogenic shock treated with ECLS in Portugal.