Evolocumab Treatment in Dyslipidemic Patients Undergoing Coronary Artery Bypass Grafting: One-Year Safety and Efficacy Results.

Background: The inhibition of PCSK9 lowered LDL cholesterol levels, reducing the risk of cardiovascular events. However, the effect on patients who have undergone surgical myocardial revascularization has not yet been evaluated. Methods: From January 2017 to December 2022, 180 dyslipidemic patients who underwent coronary artery bypass were included in the study. Until December 2019, 100 patients optimized therapy with statin ± ezetimibe (SG). Since January 2020, 80 matched patients added treatment with Evolocumab every 2 weeks (EG). All 180 patients were followed-up at 3 and 12 months, comparing outcomes. Results: The two groups are homogenous. At 3 months and 1 year, a significant decrease in the parameter mean levels of LDL cholesterol and total cholesterol is detected in the Evolocumab group compared to the standard group. No mortality was detected in either group. No complications or drug discontinuation were recorded. In the SG group, five patients (5%) suffered a myocardial infarction during the 1-year follow-up. In the EG group, two patients (2.5%) underwent PTCA due to myocardial infarction. There is no significant difference in overall survival according to the new treatment (p-value = 0.9), and the hazard ratio is equal to 0.94 (95% C.I.: [0.16-5.43]; p-value = 0.9397). Conclusions: The use of Evolocumab, which was started immediately after coronary artery bypass graft surgery, significantly reduced LDL cholesterol and total cholesterol levels compared to statin treatment alone and is completely safe. However, at one year of follow-up, this result did not have impact on the reduction in major clinical events.

Safety and Efficacy of PCSK9 Inhibitors in Patients with Acute Coronary Syndrome Who Underwent Coronary Artery Bypass Grafts: A Comparative Retrospective Analysis.

Background. The in-hospital reduction in low-density lipoprotein cholesterol (LDL-C) levels following acute coronary syndrome (ACS) is recommended in the current clinical guidelines. However, the efficacy of proprotein convertase subtilisin-kexin type 9 (PCSK9) inhibitors in those patients undergoing coronary artery bypass graft (CABG) has never been demonstrated. Methods. From January 2022 to July 2023, we retrospectively analyzed 74 ACS patients characterized by higher LDL-C levels than guideline targets and who underwent coronary bypass surgery. In the first period (January 2022-January 2023), the patients increased their statin dosage and/or added Ezetimibe (Group STEZE, 43 patients). At a later time (February 2023-July 2023), the patients received not only statins and Ezetimibe but also Evolocumab 140 mg every 2 weeks starting as early as possible (Group STEVO, 31 patients). After one and three months post-discharge, the patients underwent clinical and laboratory controls with an evaluation of the efficacy lipid measurements and every adverse event. Results. The two groups did not differ in terms of preoperative risk factors and Euroscore II (STEVO: 2.14 ± 0.75 vs. STEZE: 2.05 ± 0.6, p = 0.29). Also, there was no difference between the groups in terms of ACS (ST-, Instable angina, or NSTE) and time of symptoms onset regarding total cholesterol, LDL-C, and HDL-C trends from the preprocedural period to 3-month follow-up, but there was a more significant reduction in LDL-C and total cholesterol in the STEVO group (p = 0.01 and p = 0.04, respectively) and no difference in HDL-C rise (p = 0.12). No deaths were reported. In three STEZE group patients, angina recurrence posed the need for percutaneous re-revascularization. No STEVO patients developed significant adverse events. The statistical difference in these serious events, 7% in STEZE vs. 0% in STEVO, was not significant (p = 0.26). Conclusions. Evolocumab initiated "as soon as possible" in ACS patients submitted to CABG with high-intensity statin therapy and Ezetimibe was well tolerated and resulted in a substantial and significant reduction in LDL-C levels at discharge, 1 month, and 3 months. This result is associated with a reduction but without a statistical difference between groups.

Emergent Conversion to Open Heart Surgery during Transcatheter Aortic Valve Implantation: The Presence of a Rescue Team Improves Outcomes.

OBJECTIVE: Transcatheter aortic valve implant (TAVI) is the gold standard for the high-surgical-risk group of patients with aortic valve disease and it is an alternative to surgery in patients at intermediate risk. Lethal complications can occur, and many of these are manageable only with emergent conversion to open heart surgery. We retrospectively evaluate the outcome of all patients undergoing TAVI in our departments and the impact of a complete cardiac rescue team to reduce 30-day mortality. METHODS: Data from all patients undergoing TAVI between January 2020 and August 2023 in our center were analyzed. An expert complete rescue was present in catheter laboratory. Primary outcomes were in-hospital and at 30-day mortality and evaluation of all cases needed for emergent conversion to open heart surgery. RESULTS: 825 patients were enrolled. The total mortality was 19/825 (2.3%). Eleven of the total patients (1.3%) required emergent conversion to open heart surgery. Among them, eight were alive (73%), with a theoretical decrease of 0.98% in overall mortality. CONCLUSIONS: surgical treatment is rare during TAVI. The presence of an expert complete rescue team as support means an increase in survival. Surgery must be used only to restore circulatory and to treat complication while percutaneous approaches should complete the procedure.

ECMOLIFE intra-hospital transport in life-saving for pulmonary vein obstruction.

BACKGROUND: Transport with extracorporeal membrane oxygenation (ECMO) in the hospital setting can become a challenge as well as in the out-of-hospital setting. In particular, the management of intra-hospital transport with ECMO support of the critically ill patient foresees his shift from the intensive care to the diagnostic areas, from the diagnostic areas to the interventional and surgical areas. CASE PRESENTATION: In this context, we present a life-saving transport case with the veno-venous (VV) configuration of the ECMOLIFE Eurosets system, for right heart and respiratory failure in a 54-year-old woman, due to thrombosed obstruction of the right superior pulmonary vein, following mitral valve repair surgery in minimally invasive approach in a patient already operated on for complex congenital heart disease. After stabilizing the vital parameters with Veno-venous ECMO for 19 h, the patient was transported to hemodynamics for angiography of the pulmonary vessels, where the diagnosis of obstruction of the pulmonary venous return was made. Subsequently, the patient was brought back to the operating room for a procedure of unblocking the right superior pulmonary vein using a minimally invasive approach, passing from the ECMO to the support in extracorporeal circulation. CONCLUSIONS: The transportable ECMOLIFE Eurosets System was safe and effective during transport in maintaining the vital parameters of oxygenation and CO2 reuptake and systemic flow, allowing the patient to be mobilized for diagnostic tests instrumental to diagnosis. The patient was extubated 36 h after the surgical procedures and was discharged 10 days later from the hospital.

The influence of metabolic syndrome in heart valve intervention. A multi-centric study.

BACKGROUND: The effect of metabolic syndrome (MetS), defined as insulin resistance along with two or more of: obesity, atherogenic dyslipidaemia and elevated blood pressure, on postoperative complications after isolated heart valve intervention remains controversial. We hypothesized that MetS may negatively influence the postoperative course in these patients. METHODS: Patients from 10 cardiac units who underwent isolated valve intervention (mitral ± $\pm $ tricuspid repair/replacement (mitral valve surgery [MVS]) or surgical aortic valve replacement (SAVR), or transcatheter aortic valve replacement (TAVR) were included. MetS was defined according to the World Health Organization criteria. Primary outcome was in-hospital mortality and overall postoperative length of stay (LOS). Relevant postoperative complications were also recorded. RESULTS: From 2010 to 2019, 17,283 patients underwent valve intervention. The MVS, SVAR, and TAVR accounted for the 39.4%, 48.2%, and 12.3% respectively of the whole. MetS compared to no-MetS was associated to higher mortality in the MVS group (6.5% vs. 2%, p < .001), but not in the SAVR and TAVR group. In both surgical cohorts, MetS was associated with increased complications including red blood cells transfusion, renal failure, mechanical ventilation time, intensive care and overall postoperative LOS (11 (9) vs. 10 (6), p < .001 and 10 (6) versus 10 (5) days, p = .002, MVS and [SAVR]). No differences were found in the TAVR cohort, with similar mortality and complications. CONCLUSION: MetS was associated to more postoperative complications, with higher mortality in the MVS group. In the TAVR cohort, postoperative complications and mortality rate did not differ between patients with and without MetS, however LOS was longer in the MetS group.

Perioperative left ventricular perforation in incomplete TAVI and completion of the procedure after surgical repair.

BACKGROUND: The use of transcatheter aortic valve implantation (TAVI) continues to grow worldwide. Despite increased operator experience, evolution of the technique, and deflectable catheters, major complications still occur in ≤ 6% up to 8% of cases. Such major complications have been associated with a 2- to threefold increase in 30-day mortality. Complications specifically involving the aorta, aortic valve annulus, or left ventricle are rare, occurring in only 0.2-1.1% of cases. CASE PRESENTATION: We report the case of a 65-year-old female patient with left ventricular lateral wall perforation during incomplete implantation of a TAVI device, and successive percutaneous completion after surgical repair of the lesion under cardiopulmonary bypass. The surgical strategy and the type of surgical treatment depend on the type of perforation. In general, repair of the lesion and aortic valve replacement are performed. Removal of the TAVI prosthesis and excision of the native aortic valve are standard parts of this repair. CONCLUSION: Here we propose a safe alternative for the completion of the TAVI approach after surgical repair, which requires close coordination between the members of the heart team (anesthesiologist, perfusionist, cardiologist, nurse and cardiac surgeon).

Remote ischemic preconditioning in isolated valve intervention. A pooled meta-analysis.

OBJECTIVE: Recent studies have shown no benefits from remote ischemic preconditioning (RIPC) in patients undergoing coronary artery bypass surgery. One possible explanation is that given previous exposure to angina and ischemia/reperfusion injury these patients, may be already 'naturally preconditioned'. The role of RIPC in a context of isolated valve intervention, both surgical and particularly transcatheter is less clear and remains under investigated, with few high-quality studies. METHODS: A systematic literature review identified 8 candidate studies that met the meta-analysis criteria. We analyzed outcomes of 610 subjects (312 RIPC and 298 SHAM) with random effects modeling. Each study was assessed for heterogeneity. The primary outcome was the extent of periprocedural myocardial injury, as reflected by the area under the curve for serum troponin concentration. Secondary endpoints included relevant intra- and post-operative outcomes; sensitivity and high-quality subgroup analysis was also carried out. RESULTS: Six and two studies reported the effect of RIPC in surgical and transcatheter valve intervention. There was a significant difference between-group in terms of periprocedural Troponin release (standardized mean difference (SMD: 0.74 [95% CI: 0.52; 0.95], p = 0.02) with no heterogeneity (χ2 2.40, I2 0%, p = 0.88). RIPC was not associated with any improvement in post-operative outcomes. No serious adverse RIPC related events were reported. CONCLUSIONS: RIPC seems to elicit overall periprocedural cardioprotection in patients undergoing valvular intervention, yet with no benefit on early clinical outcomes.

Percutaneous exclusion of ascending aorta pseudoaneurysms: still an interventional challenge?

Ascending aortic pseudoaneurysm is a rare pathology that could have multiple etiologies such as thoracic trauma, infection, and percutaneous or surgical procedures. In patients with aortic pseudoaneurysms, open surgical or endovascular interventions are always indicated, if feasible and independent of size. Several types of endovascular treatment have been reported in the literature, but they have been mostly restricted to those cases when traditional surgery has a prohibitive risk. We report the case of a 75-year-old man with a sinotubular junction pseudoaneurysm, likely developed after coronary artery bypass grafting, which was successfully treated by implanting a multifenestrated cribriform septal occluder, a device already used in few similar cases. .

Time-dependent benefits of pre-treatment with new oral P2Y12 -inhibitors in patients addressed to primary PCI for acute ST-elevation myocardial infarction.

OBJECTIVES: The aim of this observational study was to determine the benefits of the novel, orally delivered P2Y12 -inhibitors (Is) in terms of angiographic endpoints and in relation to the time of the loading dose (LD) administration. BACKGROUND: The goal of ST-elevation myocardial infarction (STEMI) treatment is timely reperfusion. The P2Y12 -Is prasugrel and ticagrelor have improved the angiographic outcome of primary percutaneous coronary intervention (pPCI) and patients' prognosis. However, their onset of action is impaired in STEMI and delayed by their oral administration. METHODS: The 328 eligible patients with STEMI consecutively referred for pPCI were divided into three groups depending on the interval of "P2Y12 -I LD administration-to-balloon time": Group 2 included patients that received P2Y12 -I LD at least 60 min prior to pPCI, Group 1 within 60 min prior to pPCI, and Group 0 at the moment of pPCI. Angiographic, clinical, and biochemical parameters were evaluated. Pre- and post-pPCI TIMI flow grade (TFG) and ST resolution (STR) were used as outcome measures to determine efficacy and optimal timing of pretreatment. RESULTS: Pre-pPCI TFG improved with increasing P2Y12 -I LD administration-to-balloon time; pre-PCI TFG 0/1 was 74.5% in Group 0, 65.5% in Group 1 and 54.9% in Group 2 (P < 0.002). Post-pPCI TFG 3 results also differed significantly between the three groups: 85.2% in Group 0, 88.1% in Group 1, 97.6% in Group 2 (P < 0.013). ST resolution rates were also positively associated with longer pretreatment intervals. CONCLUSIONS: This observational study suggests that the angiographic benefit of P2Y12 -I administration is time-dependent: longer pretreatment improves coronary reperfusion in terms of pre- and post-pPCI TFG and STR.

Hybrid three-stage repair of mega-aortic syndrome with the Lupiae technique: 10-year results.

BACKGROUND: Mega-aortic syndrome (MAS) is a rare disease carrying a poor prognosis if treated conservatively. Open repairs of these aneurysms are invasive, while totally endovascular repairs are associated with higher rates of late reintervention due to endoleaks, compromising long-term prognosis. We describe the 10-year results of a hybrid three-stage approach to MAS using the Lupiae technique. METHODS: Between 2006 and 2016, 27 patients with MAS extending from the ascending aorta to the iliac arteries (MAS type III) underwent: (I) a surgical aortic arch debranching, using the Vascutek Lupiae™ multibranched graft to create a proximal Dacron landing zone; (II) an abdominal aorta debranching to create a distal Dacron landing zone and (III) the implantation of multiple endovascular stents to exclude any residual aneurysm between the two landing zones. RESULTS: One patient died following the first stage, and another following the second stage of the repair (overall mortality 7.4%). The interval between the first and the second stage was 58.3±16.1 days. The interval between the second and the third stage was 47.7±13.1 days. Four-year survival was 88.6%±6.2% while 10-year survival was 51.7%±17.9%. One patient had a type III endoleak after the third stage that self-resolved within 6 months without intervention. No patient had type I or II endoleaks and none underwent redo procedures. Mean follow-up was 5.9±3.6 years and completeness was 100%. CONCLUSIONS: Three-stage hybrid repairs using the Lupiae technique can be safely performed in MAS type III patients. Short intervals between the stages should mitigate the risk of rupture during the waiting periods and may enhance patient compliance, but to achieve this, the burden and the complexity of the first stage must be carefully weighted. Our strategy improves the long-term survival of these patients compared to their natural history and is less invasive than an open repair. The adoption of Dacron landing zones appears to be associated with very low rates of reintervention due to endoleaks.

Hybrid three-stage repair of mega aorta with Lupiae technique: tips and tricks.

Mega aorta syndrome (MAS) poses a complex clinical challenge: the involvement of the ascending aorta, aortic arch, descending thoracic and abdominal aorta with extension below the origin of renal arteries requires almost total replacement of the aorta. The modality of treatment remains still controversial. Different aortic debranching techniques have been developed to re-route the origin of epiaortic and visceral vessels and achieve an optimal landing zone for implantation of subsequent endovascular grafts. We illustrate the Lupiae technique as a further evolution of the aortic debranching and hybrid repair of a mega aorta. It was developed with the purpose to exclude a very long segment of diseased aorta by implanting two or more endoprostheses between two surgically-generated landing zones. We describe a series of 27 patients treated by this hybrid three-stage mega-aorta repair; the tips and tricks discussed here facilitate a safe and effective procedure, enable treatment of frail patients and help to avoid life-threatening complications.

Transcatheter Simultaneous Double-Transapical Access for Paravalvular Mitral Leak Closure Using the Occlutech PLD.

A 67-year-old patient with rheumatic heart valve disease had undergone two cardiac surgeries at the age of 30 years, then re-do with mitral valve replacement at 50 years. She presented with congestive heart failure and hemolytic anemia. Doppler echocardiography showed moderate-severe mitral regurgitation due to paravalvular mitral valve leak (PVML) and severe pulmonary hypertension. Transesophageal echocardiography demonstrated severe PVML secondary to a large 20 mm-long PVML defect. Due to comorbidities, the heart team deemed a third reoperation at very high surgical risk; therefore, the patient was considered most suitable for a transcatheter approach to PVML closure. Two Occlutech paravalvular leak devices were successfully delivered using a simultaneous double-transapical access with double-wire technique.

Management strategies in patients affected by chronic total occlusions: results from the Italian Registry of Chronic Total Occlusions.

BACKGROUND: Through contemporary literature, the optimal strategy to manage coronary chronic total occlusions (CTOs) remains under debate. OBJECTIVES: The aim of the Italian Registry of Chronic Total Occlusions (IRCTO) was to provide data on prevalence, characteristics, and outcome of CTO patients according to the management strategy. METHODS: The IRCTO is a prospective real world multicentre registry enrolling patients showing at least one CTO. Clinical and angiographic data were collected independently from the therapeutic strategy [optimal medical therapy (MT), percutaneous coronary intervention (PCI), or coronary artery bypass grafting (CABG)]; a comparative 1-year clinical follow-up was performed. RESULTS: A total of 1777 patients were enrolled for an overall CTO prevalence of 13.3%. The adopted therapeutic strategies were as follows: MT in 826 patients (46.5%), PCI in 776 patients (43.7%), and CABG in the remaining 175 patients (9.8%). At 1-year follow-up, patients undergoing PCI showed lower rate of major adverse cardiac and cerebrovascular events (MACCE) (2.6% vs. 8.2% and vs. 6.9%; P < 0.001 and P < 0.01) and cardiac death (1.4% vs. 4.7% and vs. 6.3%; P < 0.001 and P < 0.001) in comparison with those treated with MT and CABG, respectively. After propensity score-matching analysis, patients treated with PCI showed lower incidence of cardiac death (1.5 vs. 4.4%; P < 0.001), acute myocardial infarction (1.1 vs. 2.9%; P = 0.03), and re-hospitalization (2.3 vs. 4.4% P = 0.04) in comparison with those managed by MT. CONCLUSIONS: Our data showed how CTO PCI might significantly improve the survival and decrease MACCE occurrence at 1 year follow-up in comparison with MT and/or CABG.

Mid-term results of the Lupiae technique in patients with De Bakey Type I acute aortic dissection.

OBJECTIVES: The late persistence of a patent and dilated false lumen into the thoracic aorta is associated to higher re-operation rates and to a worse prognosis after the surgical repair of De Bakey Type I acute aortic dissection (TIAAD). We present the mid-term results of a hybrid, two-stage technique for TIAAD aimed to reduce the risk of late expansion of the residual false lumen. METHODS: From May 2005 to January 2011, 49 patients with TIAAD were treated with the Lupiae technique. During the emergency operation, a Vascutek Lupiae™, a multi-branched Dacron prosthesis, was implanted to replace the ascending aorta, the aortic arch and to reroute the origin of the epiaortic vessels. The debranching of the aortic arch creates a long and stable Dacron landing zone on the ascending aorta suitable for further endovascular interventions. Postoperatively, 34 patients with a patent or partially thrombosed false lumen > 22 mm or a diameter of the descending aorta > 46 mm underwent the implant endovascular stentgrafts into the descending aorta. RESULTS: Three patients died after the first procedure. One patient died after the endovascular stage. No patient experienced paraplegia or stroke. The 6-year follow-up survival was 90 ± 4%. The obliteration of the false lumen was obtained in 94% of the patients. CONCLUSIONS: In patients with TIAAD, the debranching of the aortic arch with the Lupiae technique can be safely performed. This technique creates a long and stable landing zone that can be easily used for the deployment of endovascular stentgrafts in case of distal false lumen expansion.

Use of Proxis for percutaneous coronary intervention in patients with totally occluded saphenous vein grafts: an alternative approach.

Surgery is a common approach for diffuse coronary artery disease. Saphenous vein grafts are frequently used but are characterized by degeneration and high incidence of failure at 10 years. Percutaneous coronary intervention is preferred over re-operation because of age, comorbidity and the diffusion of coronary artery disease. With the saphenous vein graft occluded, percutaneous coronary intervention of native vessels and medical therapy alone are commonly suggested. We report three cases of patients with totally occluded saphenous vein grafts with suitable characteristics for treatment with Proxis, a device able to induce a proximal protection of the target vessel, minimizing the risk of distal embolization as well as the quantity of contrast required. In all patients there were no complications or cardiac enzyme elevations, and each case resulted in complete revascularization immediately postprocedure. Patients were asymptomatic at 6-month follow-up and procedural success was shown in two patients that consented to follow-up angiography. We conclude that Proxis could be a valuable tool for percutaneous coronary intervention of totally occluded saphenous vein grafts in patients who are poor candidates for percutaneous coronary intervention of native vessel; nevertheless these observations should be confirmed by a long-term follow-up controlled study.