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.

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.

10-Year Impact of Transcatheter Aortic Valve Replacement Leaflet Design (Intra- Versus Supra-Annular) in Mortality and Hemodynamic Performance.

Background: The impact of transcatheter aortic valve replacement (TAVR) leaflet design on long-term device performance is still unknown. This study sought to compare the clinical and hemodynamic outcomes of intra- (IA) versus supra-annular (SA) TAVR designs up-to 10-years following implantation. Methods: Consecutive patients with at least 5-years follow-up following TAVR for severe symptomatic aortic stenosis from June 2007 to December 2016 were included. Bioprosthetic valve failure (BVF) and hemodynamic valve deterioration (HVD) were defined according to VARC-3 updated definitions and estimated using cumulative incidence function to account for the competing risk of death. Results: A total of 604 patients (82 years; 53% female) were analyzed and divided into IA (482) and SA (122) groups. Overall survival rates at 10-years were similar (IA 15%, 95%CI: 10-22; SA 11%, 95%CI: 6-20; p = 0.21). Compared to the SA TAVR, mean transaortic gradients were significantly higher and increased over time in the IA group. IA TAVRs showed higher 10-year cumulative incidences of BVF (IA 8% vs. SA 1%, p = 0.02) and severe HVD (IA 5% vs. SA 1%, p = 0.05). The occurrence of BVF and HVD in the IA group occurred primarily in the smallest TAVR devices (20-23-mm). After excluding these sizes, the cumulative incidences of BVF (IA 5% vs. SA 1%, p = 0.40) and severe HVD (IA 2% vs. SA 1%, p = 0.11) were similar. Conclusion: In this study, TAVR leaflet design had no impact on survival at 10-years. IA devices showed higher transaortic gradients and cumulative incidences of HVD and BVF predominantly occurring in the smallest valve sizes.

Transcatheter Valve-in-Valve Implantation in an Aortic Bioprosthesis With Severe Regurgitation and a Challenging Aortic Anatomy.

Valve-in-valve transcatheter aortic valve replacement for failing surgical bioprosthetic valves becomes troublesome if a stiff vascular prosthesis replaces the ascending aorta. We report the off-label use of a new transcatheter aortic valve for treatment of a patient with a bioprosthetic valve with central regurgitation, a horizontal aorta, and kinking of the aortic prosthesis. (Level of Difficulty: Intermediate.).

Primary Percutaneous Coronary Intervention with High-Bolus Dose Tirofiban: The FASTER (Favorite Approach to Safe and Effective Treatment for Early Reperfusion) Multicenter Registry.

Objectives: To investigate the safety and clinical efficacy of tirofiban during primary percutaneous coronary interventions (pPCI). Background: Gp IIb/IIIa inhibitors (GPI) use during pPCI has declined over years, mainly for the increased hemorrhagic risk associated to their use and for the availability of potent, fast-acting oral antiplatelet drugs. However, several pharmacodynamic studies showed suboptimal platelet inhibition with P2Y12-blockers, such as prasugrel or ticagrelor. Methods: Patients with ST-segment elevation myocardial infarction (STEMI) undergoing pPCI were prospectively enrolled in a multicenter registry conducted in high-volume centers in Italy. All patients received intraprocedural tirofiban. The primary safety endpoint was the occurrence of in-hospital bleedings according to the Bleeding Academic Research Consortium definition. In-hospital major adverse coronary events (MACE, defined as death, reinfarction, stent thrombosis, and target vessel revascularization), final TIMI flow, myocardial blush grade, and ST-segment resolution were also evaluated. Results: A total of 472 patients (mean age 61 ± 11 years, 83% males) were enrolled in 16 Italian centers from October 2015 to June 2018. Mean basal thrombus grade score was 3.47 ± 1.25. PCI was performed by transradial approach in 88% of patients. We observed a very low rate of 30 days BARC bleedings (2.1%) and MACE (0.8%). Complete (>70%) ST-segment resolution was observed in 67% of patients. Conclusions: In the FASTER registry, the use of tirofiban during primary PCI, performed with a transradial approach in most cases, in patients with high thrombus burden was associated with high rates of complete ST-segment resolution and low rates of in-hospital bleeding and MACE.

Real-World Experience With a Large Bore Vascular Closure Device During TAVI Procedure: Features and Predictors of Access-Site Vascular Complications.

Backgrounds: Among vascular closure devices (VCDs), the novel collagen plug-based MANTA VCD is the first designed for large bore percutaneous access. We aimed to assess the features and predictors of access-site vascular complications in an unselected trans-femoral transcatheter aortic valve replacement (TF-TAVR) population. Methods: Patients undergoing large bore arteriotomy closure with 18F MANTA VCD following TF-TAVR at a large tertiary care center from September 2019 to January 2021 were prospectively analyzed. Primary Outcome was the MANTA VCD access-site-related complications according to Valve Academic Research Consortium-3 (VARC) definitions. Its incidence and predictors were evaluated. Results: Eighty-eight patients (median age 82 years, 48% male, 3.3 median Society of Thoracic Surgeons score) undergoing TF-TAVR were included, mostly (63%) treated with a self-expandable device and with outer diameter sizes varied from 18F to 24-F. MANTA VCD technical success rate was 98%, while 10 patients (11%) experienced MANTA VCD access-site vascular complications which included 8% of minor complications and only to 2% of major events resulting in VARC type ≥2 bleeding. Vessel occlusion/stenosis (60%), perforation (20%), and pseudoaneurysm/dissection/hematoma (20%) occurred, but all were managed without surgical treatment. Independent predictors of failure were age (p = 0.04), minimum common femoral artery diameter (CFA) (p < 0.01), sheath-to-femoral-artery ratio (SFAR) (p < 0.01), and a lower puncture height (p = 0.03). A CFA diameter <7.1 mm with a SFAR threshold of 1.01 were associated with VCD failure. Conclusions: In a more comers TF-TAVR population, MANTA VCD was associated with reassuring rates of technical success and major access-site vascular complications. Avoiding lower vessel size and less puncture site distance to CFA bifurcation might further improve outcomes.

Sutureless versus transcatheter aortic valve replacement: A multicenter analysis of "real-world" data.

BACKGROUND: Recent data suggested that transcatheter aortic valve replacement (TAVR) may be indicated also for low-risk patients. However, robust evidence is still lacking, particularly regarding valve performance at follow-up that confers a limitation to its use in young patients. Moreover, a literature gap exists in terms of 'real-world' data analysis. The aim of this study is to compare the cost-effectiveness of sutureless aortic valve replacement (SuAVR) versus transfemoral TAVR. METHODS: Prospectively collected data were retrieved from a centralized database of nine cardiac surgery centers between 2010 and 2018. Follow-up was completed in June 2019. A propensity score matching (PSM) analysis was performed. RESULTS: Patients in the TAVR group (n=1002) were older and with more comorbidities than SuAVR patients (n=443). The PSM analysis generated 172 pairs. No differences were recorded between groups in 30-day mortality [SuAVR vs TAVR: n=7 (4%) vs n=5 (2.9%); p=0.7] and need for pacemaker implant [n=10 (5.8%) vs n=20 (11.6%); p=0.1], but costs were lower in the SuAVR group (20486.6±4188€ vs 24181.5±3632€; p<0.01). Mean follow-up was 1304±660 days. SuAVR patients had a significantly higher probability of survival than TAVR patients (no. of fatal events: 22 vs 74; p<0.014). Median follow-up was 2231 days and 2394 days in the SuAVR and TAVR group, respectively. CONCLUSION: The treatment of aortic valve stenosis with surgical sutureless or transcatheter prostheses is safe and effective. By comparing the two approaches, patients who can undergo surgery after heart team evaluation show longer lasting results and a more favorable cost ratio.

[Single versus double antiplatelet therapy following coronary artery bypass grafting]. / Terapia antipiastrinica singola o doppia nei pazienti sottoposti a intervento di bypass aortocoronarico.

Coronary artery bypass grafting is the treatment of choice in complex obstructive coronary artery disease, particularly in diabetic patients. The long-term benefits of coronary artery bypass grafting depend on the successful execution of the anastomosis, on the appropriate choice of conduits (arterial rather than venous) but are also influenced, as for the coronary stent, by the pharmacological measures used to prevent occlusion both in the period immediately following the intervention and in the subsequent years. The use of aspirin at intermediate doses, before and after surgery, clearly improves the clinical prognosis and bypass patency but does not prevent occlusion of venous bypasses from occurring in 10-20% of cases at 1 year of follow-up and in about 50% at 10 years. The combination of aspirin with first or more recent generation thienopyridines (dual antiplatelet therapy, DAPT) has produced conflicting results in the various randomized controlled trials. However, based on the most recent meta-analyses, there seems to be reason for a wider use of DAPT for at least 6 months after surgery for patients undergoing saphenous vein revascularization with a slightly higher risk of bleeding. This strategy could serve to reduce the risk of graft thrombosis as a consequence of the pro-thrombotic and pro-inflammatory state characterizing the first postoperative weeks.

Transcatheter Therapies in Challenging Aortic Ailments: TAVR in Extreme Horizontal Aortic Root With CoA Stenting.

Transcatheter aortic valve replacement (TAVR) for severe aortic stenosis in older adults may be challenging because of additional aortic comorbidities such as aortic coarctation (CoA). We report successful snared-assisted transfemoral TAVR in a patient with an extremely horizontal ventriculoaortic axis that was worsened by a previous endovascular repair of complex CoA. (Level of Difficulty: Advanced.).

Transradial approach for carotid artery stenting: A position paper from the Italian Society of Interventional Cardiology (SICI-GISE).

Carotid artery stenting (CAS) is a valid and effective alternative to endoatherectomy when performed by experienced operators. The conventional approach used is the transfemoral one, but in the last 10 years a transradial (TR) approach, the standard access for cardiac catheterization, became widely adopted for peripheral vascular interventions, included the extracranial carotids. Preliminary experiences suggest this approach as safe and effective, especially in specific anatomical and clinical settings that have been shown to be associated with high risk of complications from the femoral route. Lacking international guidelines, this document, promoted by the Italian Society of Interventional Cardiology - Gruppo Italiano Studi Emodinamici (SICI-GISE), was drawn-up by a panel of interventional cardiologists with a documented experience on the subject, focusing on the indications, techniques and materials that should be used for this type of intervention and the most recent literature on the subject.

Mechanical circulatory support and intravascular lithotripsy in high-risk patients undergoing percutaneous coronary intervention and transcatheter aortic valve replacement: a case series.

BACKGROUND: Patients undergoing transcatheter aortic valve replacement (TAVR) usually have multiple comorbidities, such as severely impaired left ventricular function (LVF) and heavily calcified coronary lesions. When they undergo pre-TAVR high-risk percutaneous coronary interventions (HR-PCIs) for severely calcified left main (LM) lesions, potential life-threatening intra-procedural complications associated with the different techniques available to treat calcified lesions can arise. In this setting, mechanical circulatory support proves its usefulness. However, the choice of device can be troublesome. CASE SUMMARY: We report two clinical scenarios of intravascular lithotripsy (IVL) for the treatment of heavily calcified LM coronary lesions, wherein peripheral veno-arterial extracorporeal membrane oxygenation (VA-ECMO), alone or combined with an intra-aortic balloon pump (IABP), were used as an upfront strategy to support the procedure. The use of these techniques was particularly effective during multi-vessel HR-PCIs and TAVR, and no complications occurred, which suggested their safety. DISCUSSION: These cases provide multiple insights into the strategy of using IVL + VA-ECMO, alone or with IABP, to treat heavily calcified LM coronary lesions in patients with severely compromised LVF undergoing TAVR. IVL safely and effectively overcame shortcomings related to other plaque ablation techniques, and VA-ECMO proved to be effective when facing the combination of high-risk coronary and valve interventions.

[GISE (Italian Society of Interventional Cardiology) Position paper: Short-term hospitalization for percutaneous coronary intervention; a helpful tool to manage post-COVID-19 backlogs]. / Position paper GISE (Società Italiana di Cardiologia Interventistica): Ricovero breve per la PCI in elezione, uno strumento per la "ripartenza".

Minimization of hospital lengths of stay has always been a key goal for healthcare systems. More so during the current COVID-19 pandemic. In fact, we have faced a reduction in no-COVID-19 admissions with the generation of huge backlogs. Low-risk patients undergoing elective percutaneous coronary intervention (PCI) can be candidate for short-term hospitalization, with consequent reduction of waiting lists. Several single-center and multicenter observational studies, multiple randomized trials and some meta-analyses have addressed this topic.In this position paper, we present a proposal for short hospitalization for elective PCI procedures in selected patients who present complications only exceptionally and exclusively immediately after the procedure, if the inclusion and exclusion criteria are met. Each Center can choose between admission in day surgery or one day surgery, extending hospital length of stay only for patients who present complications or who are candidate for urgent surgery. Short-term hospitalization considerably reduces costs even if, with the current model, it generally results in a parallel reduction in reimbursement. Hence, we present an actual model, already tested successfully in an Italian hospital, that warrants sustainability. This approach can then be tailored to single Centers.

[Impact of COVID-19 pandemic on structural heart interventions in Italy]. / Impatto della pandemia da COVID-19 sulla cardiologia interventistica strutturale in Italia.

BACKGROUND: The coronavirus disease 2019 (COVID-19) pandemic has led to deferral of many non-urgent procedures in most healthcare systems worldwide. With this study we aimed to quantify the impact of COVID-19 on interventional treatment of structural heart disease (SHD) in Italy. METHODS: Numbers of transfemoral transcatheter aortic valve replacement (TAVR), percutaneous mitral valve repair (PMVR), left atrial appendage occlusion (LAAO), patent foramen ovale (PFO) closures performed over a 4-week period during the national lockdown in Italian centers performing over 60 structural heart interventions (SHI)/year were compared with the same 4-week period in 2019. Incidence rate reductions (IRR) were estimated by zero-inflated negative binomial regression. RESULTS: According to our nationwide analysis, SHIs were reduced by 79% as compared to the same period in 2019 (IRR 0.21, 95% confidence interval [CI] 0.15-0.29). This reduction was more substantial for PFO closure (IRR 0.03, 95% CI 0.01-0.07), LAAO (IRR 0.11, 95% CI 0.05-0.25) and PMVR (IRR 0.12, 95% CI 0.04-0.36) as compared to TAVR (IRR 0.31, 95% CI 0.22-0.47). CONCLUSIONS: The COVID-19 pandemic caused a 79% drop in SHI volumes in Italy. PFO closure, LAAO and PMVR decreased more significantly as compared to TAVR. Further studies are needed to evaluate the impact of this reduction on outcomes of patients with SHD.

A cascade of multiple complications hampering a complex high-risk percutaneous coronary intervention (CHIP-PCI): When ingenuity overcomes troubles!

Even skilled CHIP operators can run into multiple complications. Some are unexpected and not related to the operator, and others are fully preventable by careful procedural choices. If those occur, the knowledge of devices and cognitive skills become lifesaving elements and sudden issues need to be dealt with calmly and efficiently.

Transcatheter aortic valve-in-valve post-dilatation as an overlooked risk factor of delayed coronary obstruction: a case report.

BACKGROUND: The risk of coronary obstruction during transcatheter aortic valve-in-valve replacement (VIV-TAVR) in patients deemed at high risk for surgical re-intervention is still a concerning issue. CASE SUMMARY: A 78-year-old woman with a past medical history of hypertension, chronic kidney disease, and rheumatoid arthritis was referred for a symptomatic and severely stenotic surgical Mitroflow n.21 bio-prosthesis and was subsequently recommended for a VIV procedure. Multiple anatomical risk factors for coronary occlusion required a pre-emptive coronary chimney stenting protection. The implantation of an Evolut-R 23 mm valve resulted in a gradient of 21 mmHg thus, a post-dilatation with an 18 mm balloon was performed. Both electrocardiographic and haemodynamic parameters remained excellent, however, a hazardous leaflet dislodgment became evident. Regardless, a prophylactic chimney stenting was performed because of the operator's perceived high risk of late coronary occlusion. DISCUSSION: The implantation of transcatheter valves inside failed surgically implanted aortic bio-prosthesis is broadly recognized as a safe and less-invasive alternative to repeated high-risk surgery. Although procedural success is achieved in the great majority of patients, this therapy may be jeopardized by rare but serious complications such as impending or established acute coronary occlusion. Several specific anatomical and procedural risk factors have been identified and primary coronary prevention strategies are often mandatory when they arise. Valve-in-valve post-dilation has been overlooked in its role as an additional risk factor of late coronary obstruction. Therefore, chimney stenting, performed after balloon post-dilation to prevent delayed coronary obstruction, even if the acute coronary event does not occur intra-procedurally, is strongly advisable.

Downstream or upstream administration of P2Y12 receptor blockers in non-ST elevated acute coronary syndromes: study protocol for a randomized controlled trial.

BACKGROUND: The optimal timing to administer a P2Y12 inhibitor in patients presenting with a non-ST elevation acute coronary syndrome remains a topic of debate. Pretreatment with ticagrelor before coronary anatomy is known as a widely adopted strategy. However, there is poor evidence on how this compares with administration of a P2Y12 inhibitor after defining coronary anatomy (i.e., downstream administration). Moreover, there are limited head-to-head comparisons of the two P2Y12 inhibitors-ticagrelor and prasugrel-currently recommended by the guidelines. STUDY DESIGN: DUBIUS is a phase 4, multicenter, parallel-group, double randomized study conducted in NSTE-ACS patients designed to compare a pretreatment strategy (including only ticagrelor) versus a downstream strategy (including prasugrel or ticagrelor) and to compare downstream prasugrel with downstream ticagrelor. A total of 2520 patients will be randomly assigned to pretreatment with ticagrelor or to no pretreatment. The PCI group of the downstream arm will be further randomized to receive prasugrel or ticagrelor. The two primary hypotheses are that the downstream strategy is superior to the upstream strategy and that downstream ticagrelor is non-inferior to downstream prasugrel, both measured by the incidence of a composite efficacy and safety endpoint of death from vascular causes, non-fatal MI, or non-fatal stroke, and Bleeding Academic Research Consortium (BARC) type 3, 4, and 5 bleedings. CONCLUSIONS: The DUBIUS study will provide important evidence related to the benefits and risks of pretreatment with ticagrelor compared with a strategy of no pretreatment. Moreover, the clinical impact of using downstream ticagrelor compared with downstream prasugrel will be assessed. TRIAL REGISTRATION: ClinicalTrials.gov NCT02618837 . Registered on 1 December 2015.

Timing of Oral P2Y12 Inhibitor Administration in Patients With Non-ST-Segment Elevation Acute Coronary Syndrome.

BACKGROUND: Although oral P2Y12 inhibitors are key in the management of patients with non-ST-segment elevation acute coronary syndrome, the optimal timing of their administration is not well defined. OBJECTIVES: The purpose of this study was to compare downstream and upstream oral P2Y12 inhibitors administration strategies in patients with non-ST-segment elevation acute coronary syndrome undergoing invasive treatment. METHODS: We performed a randomized, adaptive, open-label, multicenter clinical trial. Patients were randomly assigned to receive pre-treatment with ticagrelor before angiography (upstream group) or no pre-treatment (downstream group). Patients in the downstream group undergoing percutaneous coronary intervention were further randomized to receive ticagrelor or prasugrel. The primary hypothesis was the superiority of the downstream versus the upstream strategy on the combination of efficacy and safety events (net clinical benefit). RESULTS: We randomized 1,449 patients to downstream or upstream oral P2Y12 inhibitor administration. A pre-specified stopping rule for futility at interim analysis led the trial to be stopped. The rate of the primary endpoint, a composite of death due to vascular causes; nonfatal myocardial infarction or nonfatal stroke; and Bleeding Academic Research Consortium type 3, 4, and 5 bleeding through day 30, did not differ significantly between the downstream and upstream groups (percent absolute risk reduction: -0.46; 95% repeated confidence interval: -2.90 to 1.90). These results were confirmed among patients undergoing percutaneous coronary intervention (72% of population) and regardless of the timing of coronary angiography (within or after 24 h from enrollment). CONCLUSIONS: Downstream and upstream oral P2Y12 inhibitor administration strategies were associated with low incidence of ischemic and bleeding events and minimal numeric difference of event rates between treatment groups. These findings led to premature interruption of the trial and suggest the unlikelihood of enhanced efficacy of 1 strategy over the other. (Downstream Versus Upstream Strategy for the Administration of P2Y12 Receptor Blockers In Non-ST Elevated Acute Coronary Syndromes With Initial Invasive Indication [DUBIUS]; NCT02618837).

Italian Society of Interventional Cardiology (GISE) position paper for Cath lab-specific preparedness recommendations for healthcare providers in case of suspected, probable or confirmed cases of COVID-19.

COVID-19 pandemic raised the issue to guarantee the proper level of care to patients with acute cardiovascular diseases and concomitant suspected or confirmed COVID-19 and, in the meantime safety and protection of healthcare providers. The aim of this position paper is to provide standards to healthcare facilities and healthcare providers on infection prevention and control measures during the management of suspected and confirmed cases of 2019-nCoV infection accessing in cath-lab. The document represents the view of the Italian Society of Interventional Cardiology (GISE), and it is based on recommendations from the main World and European Health Organizations (WHO, and ECDC) as well as from the Italian Society of Anesthesia, Analgesia, Resuscitation and Intensive Care (SIAARTI).

Intracoronary Lithoplasty in Percutaneous Treatment of Challenging Calcified Coronary Lesions.

Unexpanded stents in calcified coronary stenosis is a problem where intravascular lithotripsy could be effectively employed. In these 2 cases, we report possible issues associated with the use of this technology. (Level of Difficulty: Intermediate.).