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.

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.

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.

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).

Long-term echocardiographic findings after TAVR: 5-year follow-up in 400 consecutive patients.

A little is known about long-term hemodynamic performance of the transcatheter heart valves (THVs). The aim of the present study was to assess hemodynamic outcome, structural valve deterioration (SVD) and bioprosthetic valve failure (BVF) in patients treated with transcatheter aortic valve replacement (TAVR) five or more years ago. All consecutive patients treated at Bologna and Florence University Hospitals with TAVR between January 2008 and December 2013 were analyzed in a retrospective registry with regards to demographic, procedural and outcome data as well as follow-up data on mortality and echocardiographic characteristics. Standardized definitions were used to define outcomes and durability of the THVs. 400 patients were included in the study, mostly treated with transfemoral TAVR (71.8%), using first generation balloon-expandable (37%) or self-expanding (63%) devices. The 1-year mortality was 21.8% (87 patients) and 5-year mortality was 53.8% (215 patients). Median follow-up was 45.5 months (14.0-68.9) totaling 1516.7 patient/years, with the longest follow-up being 10.25 years. At least one follow-up echocardiogram was available for 320 patients (80%), SVD occurred in 19 of these patients (5.94%): moderate in 17 patients (5.31%) and severe in two patients (0.63%). The hemodynamic presentation was stenosis in most of the cases (12 patients). Late BVF was registered in 10 patients (3.13%) and this was mainly driven by transcatheter paravalvular leak closure (six patients) with subsequent good long-term outcome. Our results confirm that TAVR appears to be a long-lasting treatment strategy with low rates of structural valve degeneration and valve failure.

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.].

Supra-Aortic Vessel Stenting to Stabilize an Embolized Acurate NEOTranscatheter Heart Valve: The Chandelier Technique.

THV aortic embolization can be managed percutaneously by snaring the prosthesis in a stable position in ascending aorta. We report two cases of embolized Acurate NEO with extreme mobility of devices in ascending aorta in which a bailout supra-aortic trunk stenting with consistent aortic protrusion were performed stabilizing the devices.

[Prosthesis embolization during transcatheter aortic valve implantation]. / Embolizzazione di protesi durante impianto transcatetere di valvola aortica.

Transcatheter aortic valve implantation (TAVI) has been a revolution in the treatment of severe aortic stenosis evolving to a high procedural success rate and low rate of complications. Embolization of the percutaneous device is a rare but potentially life-threatening complication. The spectrum of clinical manifestations ranges between incidental finding on cardiac imaging to cardiogenic shock or cardiac arrest. Data about predictors and management of transcatheter heart valve embolization are scarce and mostly anecdotical. Management strategies are related to the type, the size, the location of the embolized device, the timing of diagnosis, and the clinical presentation of the patient. According to recent data from TRAVEL registry, device embolization and migration occur in approximately 1% of the patients and is responsible for increased morbidity and mortality. However, in a considerable proportion of cases it could have been prevented, hence structural interventionalists should plan the procedures carefully and know thoroughly the risk factors for device embolization. Increased awareness of predisposing factors, preventive measures, and appropriate bail-out options and techniques are strongly advisable. This paper is a review of the incidence, and outcomes of percutaneous prosthesis embolization during TAVI. It also suggests an integrated algorithmic approach for the management of device embolization incorporating both percutaneous and surgical techniques.

Deep sedation vs femoral block anesthesia: beat-by-beat hemodynamic impact on TAVI procedure.

BACKGROUND: In spite of the increased use of Trans-catheter Aortic Valve Implantation (TAVI) due to the better patient selection, well-trained operators and improved technology, the choice of the best anesthesia regimen remains an open question. In particular, it remains to be clarified whether deep sedation (DS) in spontaneous breathing or femoral local anesthesia (LA) is best. OBJECTIVE: This study compared the hemodynamic variations determined by deep sedation (DS) with spontaneous breathing and local femoral anesthesia (LA) in 2 groups of patients submitted to TAVI with two different kinds of anesthesia, using a beat-by-beat pulse contour method (MostCare®-UP). METHODS: 82 patients with severe aortic stenosis and similar baseline characteristics and indications underwent trans-femoral TAVI: 50 with LA and 32 with DS. All patients were submitted to minimally invasive hemodynamic monitoring. The following parameters were measured: pressure indexes: systolic, diastolic, mean (SysP, DiaP, MAP) and dicrotic (DicP) pressures; flow indexes: cardiac output (CO), stroke volume (SV); ventriculo-arterial coupling indexes (VAC): peripheral arterial elastance (EaP), systemic vascular resistance (SVR); cardiovascular system performance: cardiac cycle efficiency (CCE), dP/dtmax_rad. RESULTS: The TAVI procedure was successful in 89% of patients (VARC-2 criteria) with no difference between the 2 groups. Anesthesia induction determined a higher decrease of pressures in DS than in LA (P<0.01) with no differences in CO. The VAC parameters (EaP, SVR) decreased (P<0.01) in DS with an improvement in CCE (P<0.001); these parameters did not change in LA. The post-TAVI flow and VAC parameters, especially Ea, increased (P<0.05) more significantly in the LA group than in the DS group (P<0.001). Using logistic regression, the occurrence of the post-TAVI aortic regurgitation was correctly associated with the pressure gradient MAP-DicP in 63% of the study population (P=0.033). This association was more effectively detected in the LA group (78%, P=0.011) with a ROC AUC=0.779, than the DS group. CONCLUSION: The use of the pulse contour method to track the fast-hemodynamic changes during the TAVI procedure proved suitable for the aim. As expected, LA and DS induced different pre-TAVI hemodynamic conditions, which influenced the post-TAVI hemodynamic changes. The hemodynamic conditions induced by LA, enabled the occurrence of post-TAVI aortic regurgitation to be detected more effectively.

New Advances in the Treatment of Severe Coronary Artery Calcifications.

Coronary artery calcifications are always challenging scenarios for interventional cardiologists. Calcium content in coronary tree directly correlates with male sex, age, Caucasian ethnicity, diabetes, and chronic kidney disease. Intracoronary imaging is useful and necessary to understand calcific lesion features and plan the best percutaneous coronary intervention strategy. Thus, accurate evaluation of patient and lesion characteristics is crucial. For this reason, definition of calcific arc, length, and thickness can suggest the best procedure before stenting and final optimization. In our modern era, different devices are available and all are surprisingly promising.

Intravascular Lithotripsy and Impella Support to Assist Complex LM Angioplasty.

Coronary and peripheral calcifications are associated with increased procedural complexity and suboptimal results in both coronary and peripheral percutaneous interventions. Intravascular lithotripsy (IVL) has recently entered the clinical scenario as a new technology for plaque modification, with promising results. We present a case of high risk left main (LM) percutaneous coronary intervention (PCI), in which peripheral Shockwave IVL was used to facilitate the delivery of an Impella CP via a 14 F sheath and coronary IVL was used to prepare a very calcific left main bifurcation lesion before stent deployment.

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.

Percutaneous Trans-septal Mitral Valve-in-Ring Implantation Using a Transcatheter Balloon-Expandable Transcatheter Heart Valve With Elective Intra-Procedural Artero-Venous ECMO in a Patient With Severely Reduced Left Ventricular Ejection Fraction.

Percutaneous mitral valve-in-valve implantation is an emerging option in patients with surgical bioprosthesis failure or failing mitral annuloplasty and increased surgical risk. We present a case of transcatheter transvenous trans-septal mitral valve-in-ring (TMVinR) procedure, in a patient with severe left ventricular dysfunction and severe mitral regurgitation, after surgical mitral annuloplasty, managed with periprocedural mechanical circulatory support (MCS) with VA-ECMO.

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.

Intravascular lithotripsy for calcific coronary and peripheral artery stenoses.

Heavily calcified lesions may be difficult to dilate adequately with conventional balloons and stents, which causes frequent periprocedural complications and higher rates of target lesion revascularisation (TLR). High-pressure non-compliant balloon angioplasty may be of insufficient force to modify calcium and, even when successful, may be limited in its ability to modify the entire calcified lesion. Scoring and cutting balloons hold theoretical value but data to support their efficacy are lacking and, because of their high lesion crossing profile, they often fail to reach the target lesion. Rotational and orbital atherectomy target superficial calcium; however, deep calcium, which may still impact on vessel expansion and luminal gain, is not affected. Intravascular lithotripsy (IVL), based on lithotripsy for renal calculi, is a new technology which uses sonic pressure waves to disrupt calcium with minimal impact to soft tissue. Energy is delivered via a balloon catheter, analogous to contemporary balloon catheters, with transmission through diluted ionic contrast in a semi-compliant balloon inflated at low pressure with sufficient diameter to achieve contact with the vessel wall. With coronary and peripheral balloons approved in Europe, peripheral balloons approved in the USA and multiple new trials beginning, we review the indications for these recently introduced devices, summarise the clinical outcomes of the available trials and describe the design of ongoing studies.