Coronary Revascularization after Transcatheter and Surgical Aortic Valve Replacement.

INTRODUCTION: Due to the selective criteria and short-term follow-up of previous transcatheter aortic valve implantation (TAVI) trials, the coronary revascularization incidence after TAVI has been difficult to determine. This study investigated the epidemiology of coronary revascularization after surgical aortic valve replacement (SAVR) and TAVI in patients with severe aortic valve stenosis (AS), with and without coronary artery disease (CAD), in a mid-term follow-up, single-center, real-world setting. METHODS: Between 2010 to 2020, 1486 patients with AS underwent SAVR or TAVI with balloon-expandable Edwards® transcatheter heart valves (THVs). Using hospital discharge records, we could estimate for each patient resident in Emilia Romagna the rate of ischemic events treated with percutaneous coronary intervention (PCI). A subgroup without CAD was also analyzed. RESULTS: The 5-year overall survival was 78.2%. Freedom from PCI after AVR and TAVI at 5 years was 96.9% and 96.9%, respectively, with previous PCI as a predictor (HR 4.86, 95% CI 2.57-9.21 p < 0.001). The freedom from PCI curves were not significantly different. CONCLUSIONS: Notwithstanding the aged population, the revascularization incidence was only 2.4%, requiring further evaluation even in younger patients with longer follow-up. Despite the profile frame raise due to the evolution of Edwards® balloon-expandable THVs, PCI or coronarography feasibility were not compromised in our population.

Effectiveness of Multilayered Polyurethane Foam Dressings to Prevent Hospital-Acquired Sacral Pressure Injuries in Patients With Hip Fracture: A Randomized Controlled Trial.

PURPOSE: The purpose of this study was to determine the effectiveness of a multilayered polyurethane foam dressing applied within 24 hours of hospital admission compared with standard preventive pressure injury (PI) care in reducing sacral PI occurrence in older patients with hip fractures. DESIGN: Open-label, parallel-group, 2-arm, superiority trial. SUBJECTS AND SETTING: The sample comprised older patients aged 69 to 97 years admitted to a 1500-bed university hospital in Bologna, Italy, for hip fracture surgery. METHODS: Patients were randomly allocated to an intervention or control group. Both groups received standard evidence-based PI preventive care in accordance with National Pressure Ulcer Advisory Panel guidelines. In addition, patients in the intervention group received a single 12.9 × 12.9-cm multilayered polyurethane foam dressing shaped for the sacrum area applied within 24 hours of hospital admission. Bivariate analysis on primary and secondary outcomes and baseline characteristics was performed to compare group differences, and a survival analysis was used to determine the difference in PI incidence rates per group. RESULTS: Sixty-eight patients completed the trial; 34 patients were allocated to the intervention group and 34 patients to the control group. A trend toward significance was observed for sacral PI occurrence in the intervention group (intervention: 20.6%; control: 2.9%; P = .054). The foam dressing allowed significantly longer time (days) to PI occurrence (intervention: 5.9 ± 1.60; control: 2.7 ± 0.96; P = .003). CONCLUSIONS: These findings suggest that multilayered polyurethane foam dressings are not superior to the standard preventive PI care alone and should be used with caution, especially when multiple dressing changes may occur. Further exploration of the role of multilayered polyurethane foam dressings in preventing PI development is warranted.

Routine minimalist transcatheter aortic valve implantation with local anesthesia only.

AIMS: Conscious sedation instead of general anesthesia has been increasingly adopted in many centers for transfemoral transcatheter aortic valve replacement (TAVR). Improvement of materials and operators' experience and reduction of periprocedural complications allowed procedural simplification and adoption of a minimalist approach. With this study, we sought to assess the feasibility and safety of transfemoral TAVR routinely performed under local anesthesia without on-site anesthesiology support. METHODS: The routine transfemoral TAVR protocol adopted at our center includes a minimalist approach, local anesthesia alone with fully awake patient, anesthesiologist available on call but not in the room, and direct transfer to the cardiology ward after the procedure. All consecutive patients undergoing transfemoral TAVR between January 2015 and July 2018 were included. We assessed the rates of actual local anesthesia-only procedures, conversion to conscious sedation or general anesthesia and 30-day clinical outcomes. RESULTS: Among 321 patients, 6 received general anesthesia upfront and 315 (98.1%) local anesthesia only. Mean age of the local anesthesia group was 83.2 ±â€Š6.9 years, Society of Thoracic Surgery score 5.8 ±â€Š4.8%. A balloon-expandable valve was used in 65.7%. Four patients (1.3%) shifted to conscious sedation because of pain or anxiety; 6 patients (1.9%) shifted to general anesthesia because of procedural complications. Hence, local anesthesia alone was possible in 305 patients (96.8% of the intended cohort, 95% of all transfemoral procedures). At 30 days, in the intended local anesthesia group, mortality was 1.6%, stroke 0.6%, major vascular complications 2.6%. Median hospital stay was 4 days (IQR 3-7). CONCLUSION: Transfemoral TAVR can be safely performed with local anesthesia alone and without an on-site anesthesiologist in the vast majority of patients.

[Update to the position paper of the Italian Society of Interventional Cardiology (SICI-GISE) on institutional and operator requirements for transcatheter aortic valve implantation (TAVI). Chapter 2: Technical nursing care in TAVI]. / Update del documento di posizione della Società Italiana di Cardiologia Interventistica (SICI-GISE) sui requisiti minimi per ospedali ed operatori che eseguono procedure di impianto transcatetere di protesi valvolare aortica (TAVI). Capitolo 2: La realtà tecnico-infermieristica nella TAVI.

Calcific degenerative aortic stenosis is the most frequent valve disease in the western population. Transcatheter aortic valve implantation procedures are significantly increasing, as they now represent the first choice in inoperable patients and have been shown to be non-inferior to cardiac surgery in patients at high and intermediate surgical risk. In this scenario, it is necessary to define and standardize the technical nursing care to guarantee patient safety and improve quality of care.The purpose of this document is to propose, on the basis on currently available literature, a model for the development of assistance based on shared objectives and clinical competence.

[SICI-GISE Position paper on the standards of cardiac catheterization laboratories in Italy: qualitative and quantitative standards of the Nurses and Allied Professionals Group]. / Documento di posizione SICI-GISE sugli standard dei laboratori di diagnostica e interventistica cardiovascolare: le professioni sanitarie del comparto standard qualitativi e quantitativi.

This document aims to be an integral part of the SICI-GISE position document on standards and guidelines for cardiovascular diagnostic intervention laboratories published in October 2015. It was created with the aim of defining quality and quantitative standards by providing practical support for the structuring of a training course to reach high levels of assistance for nursing and technical personnel working within the catheterization laboratories. The competences detected are the expression of a highly specialized organizational and operational reality that combines technicality with a well-defined clinical assistance need as an expression of a real patient care. The Nurses & Technicians Area of SICI-GISE aimed at issuing a flexible and dynamic document based on technical and operational progress which, in addition to defining qualitative and quantitative standards, describes the underlying knowledge of the professionals of the sector operating in our laboratories. This is the first experience that, through a survey carried out in 2015, has been able to decline qualitative and quantitative data so as to provide resources and skills for measuring and improving assistance outcomes.

Predictive factors for category II pressure ulcers in older patients with hip fractures: a prospective study.

OBJECTIVE: To identify the incidence of category II or higher hospital-acquired pressure ulcers (HAPU) and significantly associated factors in older patients with hip fractures. PUs are a frequent complication in hip fracture patients, negatively impacting patients' quality of life, the health-care system and society. METHOD: A prospective cohort study was conducted. A consecutive sample of patients with pertrochanteric, femoral neck or subtrochanteric fractures requiring surgical treatment, were included. A stepwise, multiple regression was performed to identify factors associated with PU development. RESULTS: A total of 761 patients aged ≥65 years were sampled. The incidence of category II or higher PUs was 12%. The study identified five factors that were significantly, independently associated with category II or higher PU development, including a higher preoperative Braden score (Hazard Ratio [HR]: 0.884; 95% confidence interval [CI]: 0.806-0.969), surgical procedure with osteosynthesis (HR 1.876; 95%CI: 1.183-2.975), a higher percentage of days with the presence of foam valve before surgery (HR: 1.010; 95%CI: 1.010-1.023) and a urinary catheter (HR: 1.013; 95%CI: 1.006-1.019) and diaper (HR: 1.007; 95% CI 1.001-1.013) in the postoperative period. CONCLUSION: Attention should be given by clinical staff to avoiding the use of foam valves, to limiting the use of diapers and to early removal of urinary catheters.

First-in-human, off-label use of BeGraft® stenting of non-conduit, large right ventricular outflow tract for transcatheter valve landing zone preparation.

Transcatheter implantation of pulmonary valve has emerged as a reliable approach in congenital heart patients presenting with chronic right ventricular volume or pressure overload after primary repair. Initial experience was limited by relatively narrow range of working diameter of transcatheter valves. Nowadays, improved technology allows extending this option to patient with large right ventricular outflow tract or conduit. A stable landing zone is of paramount importance before considering valve implantation. We present two cases of right ventricular outflow tract pre-stenting using the BeGraft® stent, which may become an interesting add to our tool kit in the preparation of valve landing zone.

Antithrombotic Management during Percutaneous Mitral Valve Repair with the Mitraclip System in a Patient with Heparin-Induced Thrombocytopenia.

Interventional cardiology procedures require full anticoagulation to prevent thrombus formation on catheters and devices with potential development of embolic complications. Bivalirudin, a short half-life direct thrombin inhibitor, has been largely used during percutaneous coronary interventions and represents the preferred alternative to heparin in patients with heparin-induced thrombocytopenia (HIT). However, few data are available about intraprocedural use of bivalirudin during transcatheter structural heart disease interventions. Activated clotting time (ACT) monitoring during bivalirudin infusion presents some limitations and it is not mandatory. We report a case of bivalirudin use in a patient with type-2 HIT during percutaneous mitral valve repair with the Mitraclip system (Abbott, Abbott Park, Illinois, United States). Despite use of standard bivalirudin dose (0.75 mg/kg bolus and 1.4 mg/kg/min infusion-reduced infusion rate was motivated by a glomerular filtration rate of 37 mL/min), the patient developed a large thrombus on the second clip during its orientation toward the mitral orifice. ACT was measured at that time and was suboptimal (240 seconds). The case was successfully managed with clip and thrombus retrieval, adjunctive 0.3 mg/kg bivalirudin bolus and increased infusion rate, and clip repositioning with ACT monitoring. This report makes the case for mandatory ACT checking and drug titration during high-risk catheter-based structural heart disease interventions, even when thromboprophylaxis is performed with bivalirudin. Additional coagulation tests may be useful to monitor bivalirudin response in similar cases.

Vascular complications after balloon aortic valvuloplasty in recent years: Incidence and comparison of two hemostatic devices.

OBJECTIVES: To define the incidence of vascular complications (VC) after balloon aortic valvuloplasty (BAV) in recent years, and to compare the performance of two vascular closure devices (VCD). BACKGROUND: VC remain the most frequent drawback of BAV and are associated with adverse clinical outcomes. METHODS: All BAV procedures performed at 2 high-volume centers over a 6-year period (n = 930) were collected in prospective registries and investigated to assess the incidence of Valve Academic Research Consortium-2 (VARC-2) defined VC. Incidence of life-threatening, major and minor bleeding was also assessed. In-hospital major adverse cardiac and cerebrovascular events (MACCE) rate (composite of in-hospital death, myocardial infarction, TIA/stroke, and life-threatening bleeding) as well as 30-day survival was compared between a suture-mediated closure system and a collagen plug hemostatic device. RESULTS: A 9 Fr arterial sheath was used in most of the patients (84.1%). Vascular closure was obtained with the Angio-Seal in 643 patients (69.1%) and the ProGlide in 287 (30.9%). The overall incidence of major VC was 2.7%, and minor VC 6.6%, without significant differences between groups. The Angio-Seal group was associated with a higher rate of small hematomas (6.9% vs. 3.5%, P = 0.042), whilst blood transfusions were more frequent in the ProGlide group (6.6% vs. 3.5%, P = 0.034). Rates of in-hospital MACCE and 30-day survival were similar. Use of either VCD was not independently associated with major VC. CONCLUSIONS: VC rate after BAV is fairly low in experienced centers without major differences between the 2 most used VCD.

Randomized comparison of balloon aortic valvuloplasty performed with or without rapid cardiac pacing: The pacing versus no pacing (PNP) study.

OBJECTIVES: To compare the effectiveness and safety of balloon aortic valvuloplasty (BAV) performed with or without rapid ventricular pacing (RP). BACKGROUND: BAV technique is poorly standardized. METHODS: One hundred consecutive patients were randomly assigned 1:1 between BAV performed with or without RP. Exclusion criteria were an immediate indication for surgical or transcatheter aortic valve replacement, presentation in cardiogenic shock or pulmonary edema refractory to medical stabilization. RESULTS: There were 51 patients in the BAV group performed with RP, 49 in the BAV group without RP (noRP). Procedural success (50% hemodynamic gradient reduction) was achieved in 37.3% and 55.1%, respectively (P = 0.16). Fewer people in the noRP group complained of poor tolerance to the procedure (16% vs 41%). The primary efficacy endpoint, a 50% reduction in the mean echocardiographic trans-aortic gradient, was met in 21/49 patients in the noRP group compared to 20/51 in the RP (42.9% vs 39.2%; P = 0.84). No significant difference between the groups was observed in the primary safety endpoint, a 30-day composite of death, myocardial infarction, stroke, acute aortic regurgitation, and BARC bleeding ≥3 (8.2% noRP vs 13.7%; P = 0.53). The noRP group required fewer bailout temporary pacemakers (P = 0.048) and had a lower incidence of moderate/severe renal function worsening (4.1% vs 17.6%; P = 0.052). CONCLUSIONS: Rapid ventricular pacing did not influence BAV efficacy or safety and tolerance was slightly worse.

Incidence, treatment, and outcome of acute aortic valve regurgitation complicating percutaneous balloon aortic valvuloplasty.

OBJECTIVES: To evaluate the incidence, treatment, and outcomes of acute aortic regurgitation (ARR) complicating BAV. BACKGROUND: In the transcatheter aortic valve implantation (TAVI) era, there is an increase of percutaneous balloon aortic valvuloplasty (BAV) procedures with different indications. METHODS: From the prospective BAV registry of the University of Bologna, which has enrolled patients between the year 2000 and the present, we selected those who suffered intraprocedural AAR with overt hemodynamic instability. Worsening of baseline aortic insufficiency without hemodynamic collapse, treatment of degenerated biological valve prosthesis, and BAV performed within a planned TAVI procedure were excluded. The main endpoints were in-hospital and 30-day mortality. RESULTS: Out of 1517 BAVs, we identified 26 cases of AAR (1.7%). This complication occurred in 80.8% of cases after one or two balloon inflations. Mean transaortic gradient decreased from 50.6 ± 19.3 to 26.0 ± 14.4 mm Hg (p < 0.01). In 8(30.8%) patients, AAR spontaneously resolved within few minutes; in 18 cases, the operators had to perform a rescue maneuver to reposition a valve leaflet got stuck in the opening position (this maneuver was successful in 13/18 of the cases, 72.2%). Out of 5 persistent AAR, 3 were managed with emergency TAVI or surgery, while 2 were unresolved. In-hospital mortality was 15.4% (n = 4), whereas no more deaths occurred up to 30 days. CONCLUSIONS: AAR is a fearsome complication of BAV and portends a grim prognosis. In some cases, it can be resolved with appropriate technical maneuvers; in others, a rescue TAVI or surgical valve replacement may be necessary. © 2015 Wiley Periodicals, Inc.

Balloon aortic valvuloplasty as a bridge-to-decision in high risk patients with aortic stenosis: a new paradigm for the heart team decision making.

BACKGROUND: Whilst the majority of the patients with severe aortic stenosis can be directly addressed to surgical aortic valve replacement (AVR) or transcatheter aortic valve implantation (TAVI), in some instances additional information may be needed to complete the diagnostic workout. We evaluated the role of balloon aortic valvuloplasty (BAV) as a bridge-to-decision (BTD) in selected high-risk patients. METHODS: Between 2007 and 2012, the heart team in our Institution required BTD BAV in 202 patients. Very low left ventricular ejection fraction, mitral regurgitation grade ≥ 3, frailty, hemodynamic instability, serious comorbidity, or a combination of these factors were the main drivers for this strategy. We evaluated how BAV influenced the final treatment strategy in the whole patient group and in each specific subgroup. RESULTS: Mean logistic European System for Cardiac Operative Risk Evaluation (EuroSCORE) was 23.5% ± 15.3%, age 81 ± 7 years. In-hospital mortality was 4.5%, cerebrovascular accident 1% and overall vascular complications 4% (0.5% major; 3.5% minor). Of the 193 patients with BTD BAV who survived and received a second heart team evaluation, 72.6% were finally deemed eligible for definitive treatment (25.4% for AVR; 47.2% for TAVI): 96.7% of patients with left ventricular ejection fraction recovery; 70.5% of patients with mitral regurgitation reduction; 75.7% of patients who underwent BAV in clinical hemodynamic instability; 69.2% of frail patients and 68% of patients who presented serious comorbidities. CONCLUSIONS: Balloon aortic valvuloplasty can be considered as bridge-to-decision in high-risk patients with severe aortic stenosis who cannot be immediate candidates for definitive transcatheter or surgical treatment.

Repeated Aortic Balloon Valvuloplasty in Elderly Patients With Aortic Stenosis Who Are Not Candidates for Definitive Treatment.

AIMS: A sizable group of patients with symptomatic aortic stenosis can undergo neither surgical aortic valve replacement nor transcatheter aortic valve implantation. The aim of this study was to assess the potential role of repeated balloon aortic valvuloplasty (BAV) in these patients. METHODS: Within our local prospective BAV registry, we retrospectively selected 105 patients who underwent ≥2 BAV procedures between 2005 and 2012 because of persisting contraindications to definitive treatment after first BAV. In-hospital outcome and incidence of adverse events at 1, 2, and 3 years were assessed. Mean age was 84 ± 6 years, mean logistic EuroSCORE was 23.6 ± 13.4%. RESULTS: No intraprocedural deaths occurred. In-hospital events for the 224 BAV procedures were: myocardial infarction, 4%; stroke, 0.9%; vascular complications, 8% (1.8% major); and bleedings, 5.9% (life threatening, 0.9%; major, 1.8%). Acute aortic regurgitation occurred in 6 cases and was always resolved during procedures. Median follow-up was 785 days. Second BAVs showed fewer vascular complications (P<.001) and bleedings (P<.001). Bleedings (odds ratio [OR], 6.88; 95% confidence interval [CI], 1.58-29.88) and vascular complications (OR, 4.8; 95% CI, 1.19-19.31) occurring after the first procedure were independent predictors for subsequent adverse events. All-cause mortality at 1, 2, and 3 years was 15.2%, 41.3%, and 57.2%. Hospital readmission for heart failure was 40.7% at 1-year follow-up, 61.7% at 2-year follow-up, and 77.6% at 3-year follow-up. CONCLUSION: BAV is associated with poor long-term clinical outcome. However, when no other therapeutic options are feasible, a strategy of repeated palliative BAV appears to be safe and is potentially associated with improved clinical outcomes.