Patient-specific computer simulation of transcatheter aortic valve replacement in patients with previous mechanical mitral prosthesis: A case series.

Transcatheter aortic valve replacement performed in patients with previously implanted mechanical mitral prosthesis represents a high risk procedure with several potential complications. We report a systematic use of a prediction model based on artificial intelligence to plan the interventional strategy in this challenging scenario.

Quality control in treating patients with patent foramen ovale: 7-year-experience of the Heart and Brain team of the Careggi University Hospital.

BACKGROUND: The right comprehension of ischemic stroke pathogenesis guarantees the best prevention therapy. The term "patent foramen ovale (PFO) related stroke" has been proposed for those events where PFO is supposed to be pathogenetic, but their definition is challenging. A multidisciplinary evaluation in a "Heart & Brain" team (HBteam) including stroke neurologists and interventional cardiologists was therefore highly recommended in the recent guidelines of secondary stroke prevention. OBJECTIVE: We aimed at describing the organization of the HBteam of Careggi-University-Hospital of Florence (Italy), and the results of the first seven years of activity. METHODS: In 2016 Interventional Cardiologists and Stroke Neurologists set up an outpatient clinic for the joined evaluation of patients with PFO and other cardio/neurological conditions. A specific diagnostic-therapeutic hospital plan was produced for PFO patients. Patient empowerment was guaranteed by a hospital explicative webpage, a booklet regarding risks/benefits of PFO closure and a 3D heartmodel to simulate the intervention. Data were collected in a dedicated registry. RESULTS: We evaluated 594 patients for PFO, 40 for left atrial appendage closure and 38 for other conditions. In 20% of PFO-patients, HBteam diagnosis was discordant from that of referring physicians, 14% were stroke misdiagnoses. We advised against closure in 53% of patients. At follow-up 94% of closed patients had no/minimum residual shunt; 3 patients had a cerebral ischemic event. CONCLUSIONS: A dedicated HBteam represents a unique opportunity to share decisions with patients after a thorough empowerment process. The joining of cardioneurological skills allows a better classification of PFO-patients, reducing futile interventions.

Advancements in Transcatheter Aortic Valve Implantation: A Focused Update.

Transcatheter aortic valve implantation (TAVI) has become the leading technique for aortic valve replacement in symptomatic patients with severe aortic stenosis with conventional surgical aortic valve replacement (SAVR) now limited to patients younger than 65-75 years due to a combination of unsuitable anatomies (calcified raphae in bicuspid valves, coexistent aneurysm of the ascending aorta) and concerns on the absence of long-term data on TAVI durability. This incredible rise is linked to technological evolutions combined with increased operator experience, which led to procedural refinements and, accordingly, to better outcomes. The article describes the main and newest technical improvements, allowing an extension of the indications (valve-in-valve procedures, intravascular lithotripsy for severely calcified iliac vessels), and a reduction of complications (stroke, pacemaker implantation, aortic regurgitation).

Role of Lithotripsy for Small Calcified Iliacs in the Era of Big Devices.

PURPOSE OF REVIEW: In recent years, transcatheter aortic valve replacement (TAVR) and percutaneous mechanical circulatory support (MCS) systems have seen a widespread diffusion. These devices require the insertion of large femoral sheaths in a population of patients often presenting with calcific peripheral artery disease. Small and severely calcified iliac vessels are associated with increased risk of vascular complications or strategy changes such as the use of an alternative subclavian or transapical approach for TAVR or a conversion to surgery. Intravascular lithotripsy (IVL) technology applies mechanical pressure waves to modify vessel calcifications. It has been applied both in coronary and peripheral calcific disease with promising results. The use in vessel preparation before the insertion of large sheaths is an emerging application of this device. RECENT FINDINGS: After case reports and presentations of isolated cases, two multicenter registries collected 42 and 12 patients treated with peripheral IVL before TAVR and MCS insertion. In most cases, the largest balloons were used in the iliac arteries with success achieved directly or using a separate insertion sheath in all cases. Low-pressure dilatation during energy delivery avoided dissections or vessel ruptures with no need of postprocedural stent implantation or emergency surgical repair. IVL can successfully modify the arterial compliance and facilitate transfemoral delivery of TAVR or MCS in patients with calcified iliofemoral vessels, reducing the need for alternative TAVR access routes and allowing to perform high-risk coronary procedures with adequate support.

Use of a steerable delivery sheath to obtain coaxial alignment in left atrial appendage occlusion after mitral transcatheter edge-to-edge repair: a case report.

Background: Patients with atrial fibrillation (AF) have a five-fold increase in stroke events, and ∼90% of the thrombi develop in the left atrial appendage (LAA). Left atrial appendage occlusion (LAAO) has emerged as a safe and feasible alternative to oral anticoagulation (OAC) for stroke prevention in selected patients with non-valvular AF and contraindications to OAC. Atrial fibrillation is closely associated with mitral disease, and there is a growing interest in combined procedures. More than half of patients undergoing a mitral transcatheter edge-to-edge repair (M-TEER) suffer of AF and many have high or unacceptable bleeding risk. Case summary: We present a case of an 80-year-old woman suffering from paroxysmal AF, right carotid siphon aneurysm, and primary mitral regurgitation, with a high bleeding risk, who underwent a combined intervention of M-TEER and LAAO. Discussion: The combination of these two procedures is a logical step once the access to the left atrium is obtained with a transseptal puncture (TSP) and a transesophageal echocardiography (TEE) is in place to guide both procedures. The turning point in LAAO procedure is a correct TSP allowing coaxial alignment of the sheath with the LAA neck. Steerable delivery sheaths are promising dedicated tools, particularly in challenging anatomy or during combined procedures requiring different TSP positions.

Contrast-Induced Acute Kidney Injury in Patients with Heart Failure on Sodium-Glucose Cotransporter-2 Inhibitors Undergoing Radiocontrast Agent Invasive Procedures: A Propensity-Matched Analysis.

(1) Background: This single-center retrospective study aimed to evaluate whether sodium-glucose cotransporter-2 inhibitors (SGLT2-i) therapy may have a nephroprotective effect to prevent contrast-induced acute kidney injury (CI-AKI) in patients with heart failure (HF) undergoing iodinated contrast medium (ICM) invasive procedures. (2) Methods: The population was stratified into SGLT2-i users and SGLT2-i non-users according to the chronic treatment with gliflozins. The primary endpoint was CI-AKI incidence during hospitalization. Secondary endpoints were all-cause mortality and the need for continuous renal replacement therapy (CRRT). (3) Results: In total, 86 patients on SGLT2-i and 179 patients not on SGLT2-i were enrolled. The incidence of CI-AKI in the gliflozin group was lower than in the non-user group (9.3 vs. 27.3%, p < 0.001), and these results were confirmed after propensity matching analysis. Multivariable logistic regression showed that only SGLT2-i treatment was an independent preventive factor for CI-AKI (OR: 0.41, 95% CI: 0.16-0.90, p = 0.045). The need for CRRT was reported only in five patients in the non-SGLT2-i-user group compared to zero patients in the gliflozin group (p = 0.05). (4) Conclusions: SGLT2-i therapy was associated with a lower risk of CI-AKI in patients with HF undergoing ICM invasive procedures.

Vascular Access in Patients With Peripheral Arterial Disease Undergoing TAVR: The Hostile Registry.

BACKGROUND: The optimal access route in patients with severe peripheral artery disease (PAD) undergoing transcatheter aortic valve replacement (TAVR) remains undetermined. OBJECTIVES: This study sought to compare clinical outcomes with transfemoral access (TFA), transthoracic access (TTA), and nonthoracic transalternative access (TAA) in TAVR patients with severe PAD. METHODS: Patients with PAD and hostile femoral access (TFA impossible, or possible only after percutaneous treatment) undergoing TAVR at 28 international centers were included in this registry. The primary endpoint was the propensity-adjusted risk of 30-day major adverse events (MAE) defined as the composite of all-cause mortality, stroke/transient ischemic attack (TIA), or main access site-related Valve Academic Research Consortium 3 major vascular complications. Outcomes were also stratified according to the severity of PAD using a novel risk score (Hostile score). RESULTS: Among the 1,707 patients included in the registry, 518 (30.3%) underwent TAVR with TFA after percutaneous treatment, 642 (37.6%) with TTA, and 547 (32.0%) with TAA (mostly transaxillary). Compared with TTA, both TFA (adjusted HR: 0.58; 95% CI: 0.45-0.75) and TAA (adjusted HR: 0.60; 95% CI: 0.47-0.78) were associated with lower 30-day rates of MAE, driven by fewer access site-related complications. Composite risks at 1 year were also lower with TFA and TAA compared with TTA. TFA compared with TAA was associated with lower 1-year risk of stroke/TIA (adjusted HR: 0.49; 95% CI: 0.24-0.98), a finding confined to patients with low Hostile scores (Pinteraction = 0.049). CONCLUSIONS: Among patients with PAD undergoing TAVR, both TFA and TAA were associated with lower 30-day and 1-year rates of MAE compared with TTA, but 1-year stroke/TIA rates were higher with TAA compared with TFA.

Peripheral intravascular lithotripsy for transcatheter aortic valve implantation: a multicentre observational study.

BACKGROUND: The presence of severe calcific atherosclerosis at the iliofemoral axis may preclude transcatheter aortic valve implantation (TAVI) by the transfemoral (TF) approach. Intravascular lithotripsy (IVL) is a novel technology that fractures intimal/medial calcium and increases vessel compliance allowing TF TAVI in selected patients with peripheral artery disease (PAD). AIMS: The aim of this study was to report on the safety and efficacy of IVL-assisted TF TAVI in an all-comers population. METHODS: Clinical, imaging and procedural data on all consecutive patients treated by IVL-assisted TF TAVI in six high-volume European centres (2018-2020) were collected in this prospective, real-world, multicentre registry. RESULTS: IVL-assisted TF TAVI was performed in 108 patients, increasing from 2.4% to 6.5% of all TAVI from 2018 to 2020, respectively. The target lesion was most often localised at the common and/or external iliac artery (93.5% of cases; average TL-MLD 4.6±0.9 mm with 318 degrees of calcium arc). Transfemoral aortic valve delivery was successful in 100% of cases; final procedural success in 98.2% (two conversions to cardiac open surgery for annular rupture and valve migration). Complications of the IVL-treated segments consisted of 1 perforation and 3 major dissections requiring stent implantation (2 covered stents and 2 BMS). Access-site-related complications included 3 major bleedings. Three in-hospital deaths were recorded (2.8%, 1 failed surgical conversion after annular rupture, 1 cardiac arrest after initial valvuloplasty, 1 late hyperkalaemia in renal dysfunction). CONCLUSIONS: IVL-assisted TF TAVI proved to be a safe and effective approach, which helps to expand the indications for TF TAVI in patients with severe calcific PAD. However, these patients continue to have a higher-than-average incidence of periprocedural complications.

Bail-out intravascular lithotripsy for severe stent underexpansion during primary angioplasty: a case report.

BACKGROUND: Intravascular lithotripsy is safe and effective for the treatment of de novo coronary artery calcifications. Its bail-out use in acute coronary syndrome and for underexpanded stents, although currently off-label, could be the best option when other conventional techniques fail. CASE SUMMARY: A patient with an inferior ST-segment elevation myocardial infarction underwent a primary percutaneous coronary intervention. Stent underexpansion due to a heavily calcified lesion was refractory to high-pressure balloon dilatations. Complete stent expansion was achieved with intravascular lithotripsy, as evidenced by intravascular ultrasound, and no acute complications occurred. DISCUSSION: Treatment strategies for stent underexpansion due to coronary artery calcifications are still debated. High-pressure non-compliant balloon dilatations are rarely sufficient to gain a complete stent expansion. Rotational and orbital atherectomy are contraindicated in presence of a thrombus. Given the possible risks of stent damages, intravascular lithotripsy is currently not indicated in acutely deployed stents but could be the best bail-out technique for otherwise undilatable stents due to severely calcified plaques.

Corrigendum to: Bail-out intravascular lithotripsy for severe stent underexpansion during primary angioplasty: a case report.

[This corrects the article DOI: 10.1093/ehjcr/ytab448.].

Changes in the perceived epidemiology of amyloidosis: 20 year-experience from a Tertiary Referral Centre in Tuscany.

BACKGROUND: Amyloidosis is considered a rare heterogeneous condition comprising different entities. Epidemiological data are limited and often controversial. We aimed to examine epidemiological changes in amyloidosis diagnosed over a 20-year period at a tertiary referral centre for amyloidosis. METHODS: We retrospectively reviewed medical files from all patients diagnosed with amyloidosis between January 2000 and December 2019, at Careggi University Hospital, Florence, Italy. Diagnosis of amyloidosis was performed as per current clinical practice and scientific evidence at the time of patient evaluation. RESULTS: We reported data on 654 consecutive patients: 274 (42%) wild type transthyretin amyloidosis (wtATTR), 68 (10%) genetic variant amyloidosis (vATTR), 281 (43%) light-chain amyloidosis (AL) and 31 (5%) serum amyloid A amyloidosis (AA). With limited fluctuations, the absolute number of new AL diagnosis increased during the 20-year period. wtATTR was unrecognized before 2009 but represented by far the most common aetiology at the end of the observation period. AA represented a residual diagnosis throughout the entire examined period. CONCLUSIONS: Following a rapid and marked increase in the number of new diagnoses over the last decade, ATTR represents by far the most common type of amyloidosis in our regional centre. These data contrasts with recent reports from national referral institutions and may help shed light on the epidemiology of the disease at the community level.

Early Diagnosis and Outcome in Patients With Wild-Type Transthyretin Cardiac Amyloidosis.

Whether diagnostic timing in transthyretin (TTR) cardiac amyloidosis (CA) predisposes patients to worse outcomes is unresolved. We aimed to describe the long-term association of diagnostic timing (time from first onset of symptoms consistent with CA leading to medical contact to definitive diagnosis) with mortality in patients with wild-type TTR-CA (ATTRwt-CA). Overall, we reviewed the medical records of 160 patients seen at a tertiary care amyloidosis unit from January 1, 2016, to January 1, 2020 (median [interquartile range] follow-up, 21 [10 to 34] months), and compared them by survival. Median diagnostic timing was 4 (2 to 12) months and was longer in nonsurvivors (9 [3 to 15] vs 3 [1 to 7] months; P<.001). Patients diagnosed 6 or more months after symptom onset had higher mortality, with a median survival of 30 months (95% CI, 22 to 37 months). On Cox multivariable analysis, timing was independently associated with all-cause mortality (hazard ratio per month increase, 1.049 [95% CI, 1.017 to 1.083]) together with age at diagnosis, disease stage, New York Heart Association class, and coronary artery disease. In conclusion, diagnostic timing of ATTRwt-CA is associated with mortality. Timely diagnosis is warranted whenever "red flags" are present.

Intravascular Imaging to Guide Lithotripsy in Concentric and Eccentric Calcific Coronary Lesions.

BACKGROUND: Calcified coronary lesions still represent a challenge for coronary angioplasty, with sub-optimal acute PCI results causing more frequent late stent failure. PURPOSE: The study aimed at the evaluation of the immediate procedural outcome in a real-world consecutive population of a selective use of lithotripsy based on the intravascular imaging assessment with IVUS or OCT. METHODS AND RESULTS: Thirty-one calcified stenoses (28 patients) out of a total of 455 lesions (370 patients) treated between November 2018 and May 2019 received IVL under intravascular imaging guidance. The majority of the IVL lesions had angiographically severe calcifications and were selected after intravascular imaging. A smaller group was identified by poor expansion after high-pressure balloon dilatation, in one case despite preliminary small burr Rotablation. After IVL, when OCT was performed calcium fractures were observed in 71% of cases. After OCT/IVUS guided stent optimization a satisfactory lumen enlargement (minimal stent area 7.09 ±â€¯2.77 mm2) was observed with good stent expansion (residual area stenosis<20% in 29 lesions, 93.5%) Peri-procedural complications were limited to one dissection at the distal edge requiring an additional stent and 3 peri-procedural myocardial infarctions. There were no periprocedural coronary perforations or pericardial effusions, and no in-hospital or 30 days stent thrombosis. When patients were divided into two subgroups according to a calcium arc ≤180° (Group A: 10 lesions, calcium arc 140 ±â€¯24°; Group B: 21 lesions, calcium arc 289 ±â€¯53°), at OCT Group B presented also a higher number of calcium fractures post IVL than group A (group A: 38% vs group B: 92%, p = 0.03). The in-stent minimum lumen diameter (MSD), the in stent minimal lumen area (MSA) and the acute gain, however, were similar between the two groups (acute gain group A: 1.22 ±â€¯0.29 mm; group B: 1.31 ±â€¯0.52 mm, p = 0.63). CONCLUSIONS: A standardized algorithm applying intravascular imaging guidance of IVL facilitated second generation DES expansion delivers excellent immediate lumen expansion and patient outcome, both in concentric and eccentric calcifications.

Contemporary Approach to Heavily Calcified Coronary Lesions.

Percutaneous treatment of heavily calcified coronary lesions still represents a challenge for interventional cardiology, with higher risk of immediate complications, late failure due to stent underexpansion and malapposition, and consequently poor clinical outcome. Good characterisation of calcium distribution with multimodal imaging is important to improve the successful treatment of these lesions. The use of traditional or new dedicated devices for the treatment of calcified lesions allows better lesion preparation; therefore, it is important that we know the different mechanisms and technical features of these devices.