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.

Atrial Fibrillation and Resistant Stroke: Does Left Atrial Appendage Morphology Matter? A Case Report.

Introduction: Patients with atrial fibrillation (AF) can experience ischemic stroke despite adequate anticoagulant therapy. The secondary prevention strategy of these so-called "resistant strokes" is empirical. Since about 90% of patients with ischemic stroke due to atrial fibrillation have thrombus in left atrial appendage (LAA) we sought to explore the possibility that resistant stroke could have a LAA morphology resistant to anticoagulants. Case Report: A 77 years old man affected by AF experienced two cardioembolic ischemic stroke while on anticoagulants. The study of LAA showed a windsock-like morphology in the proximal part while distally the LAA presented a cauliflower morphology with a large amount of pectinate muscles and blood stagnation. The precise characteristics of LAA were properly understood integrating images obtained by cardiac CT, transesophageal echocardiography, and selective angiography. A high risky LAA for thrombus formation was diagnosed and its occlusion (LAAO) as an add-on therapy to anticoagulants was proposed and performed. Six month follow-up was uneventfully. Conclusion: The systematic study of LAA in patients with resistant-stroke could help to identify LAA malignant morphology. The efficacy on stroke recurrence of the combined therapy (anticoagulants plus LAAO) is worthy to be tested in randomized trials.

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.

Cardiovascular interventions planning through a three-dimensional printing patient-specific approach.

: In recent years, three-dimensional modelling and printing techniques have improved diagnosis and preprocedural planning during percutaneous interventions or surgery in cardiovascular disease. The raw data for the whole process are obtained through medical imaging, where regions of interest, that is heart chambers, valves, aorta, coronary vessels etc., are segmented and converted into three-dimensional digital models, which are then reproduced in physical replica by a three-dimensional printer. In the current article, a freeware patient-specific three-dimensional modelling and printing step-by-step procedure for preprocedural planning for complex heart diseases is presented and applied on four patients. Finally, a general discussion on the potential and future developments of personalized three-dimensional modelling and rapid prototyping for preprocedural planning is also presented.

One more option in heart failure: correction of mitral regurgitation with MitraClip®.

Degenerative mitral regurgitation in elderly patients and functional mitral regurgitation secondary to severe left ventricular dysfunction are not easy options for conventional surgery. Recently, a new percutaneous approach has been proposed with the MitraClip®, based on the Alfieri edge-to-edge repair technique. The aim of the study is to report, compare and discuss the results of two multicenter randomized trials: MITRA.FR and COAPT in light of the current practice. In both trials patients with functional mitral regurgitation grade 3/4+ or 4/4+ were randomly assigned, in 1:1 ratio, to undergo percutaneous repair and optimal medical therapy or optimal medical therapy alone. Other baseline characteristics reflecting severity of mitral regurgitation and of left ventricular impairment were statistically different, such as the effective regurgitant orifice area (0.31 cm2 in MITRA.FR vs 0.41 cm2 in COAPT) and the indexed LVEDV (135 ± 37 ml/m2 in MITRA.FR vs 101 ± 34 ml/m2 in COAPT). A 24 months follow-up and a 12 months follow-up have been completed, respectively, in COAPT and MITRA.FR. Out of the 307 patients enrolled in the MITRA.FR, 152 were randomized to percutaneous treatment but only in 138 (95.8%) the MitraClip® was actually implanted. At the end of the follow-up a residual mitral regurgitation of at least grade 3+ has been observed in 17% of the patients. A composite of death from any cause or unplanned hospitalizations for heart failure at 12 months respectively occurred in 83 patients (54.6%) treated percutaneously and 78 patients (51.3%) treated with medical therapy only. A total of 614 patients have been enrolled in the COAPT and 293 underwent transcatheter treatment. A successful implantation of the MitraClip® was achieved in 287 patients (98.0%). Hospitalization for heart failure at 24 months occurred in 160 patients in the device group and in 283 in the control group, with an annualized ratio of 35.8% and 67.9%, respectively (p > 0.001). The conflicting results of the two trials may have many explanations, but probably the main cause is the most stringent inclusion criteria in COAPT. The effective reduction of mitral regurgitation and improvement in exercise capacity already observed in registries including more than 70,000 patients was confirmed in a randomized trial with improvement observed in hard end-points. This has already led to an extension of FDA approval to functional regurgitation and a more liberal use across the world.

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.

Transcatheter Aortic Valve Implantation in Patients With Advanced Chronic Kidney Disease.

Advanced chronic kidney disease (CKD) is associated with poor outcomes in patients who underwent surgical aortic valve replacement, whereas its prognostic role in transcatheter aortic valve implantation (TAVI) remains unclear. This study aimed to investigate outcomes in patients with advanced CKD who underwent TAVI. A total of 1,904 consecutive patients who underwent balloon-expandable TAVI in 33 centers between 2007 and 2012 were enrolled in the Italian Transcatheter Balloon-Expandable Valve Implantation Registry. Advanced CKD was defined according to the estimated glomerular filtration rate: 15 to 29 ml/min/1.73 m2 stage 4 (S4), <15 ml/min/1.73 m2 stage 5 (S5). Edwards Sapien or Sapien-XT prosthesis were used. The primary end point was all-cause mortality during follow-up. Secondary end points were major adverse cardiac events at 30 days and at follow-up, defined with Valve Academic Research Consortium 2 criteria. A total of 421 patients were staged S5 (n = 74) or S4 (n = 347). S5 patients were younger and had more frequently porcelain aorta and a lower incidence of previous stroke. Periprocedural and 30-day outcomes were similar in S5 and S4 patients. During 670 (±466) days of follow-up, S5 patients had higher mortality rates (69% vs 39%, p <0.01) and cardiac death (19% vs 9%, p = 0.02) compared with S4 patients. Male gender (hazard ratio [HR] 1.6, 95% confidence interval [CI] 1.2 to 2.2), left ventricular ejection fraction <30% (HR 2.3, 95% CI 1.3 to 4), atrial fibrillation (HR 1.4, 95% CI 1.0 to 1.9), and S5 CKD (HR 1.5, 95% CI 1.0 to 2.1) were independent predictors of death. In conclusion, TAVI in predialytic or dialytic patients (i.e., S5) is independently associated with poor outcomes with more than double risk of death compared with patients with S4 renal function. Conversely, in severe CKD (i.e., S4) a rigorous risk stratification is required to avoid the risk of futility risk.

Predictive ability of the CHADS2 and CHA2DS2-VASc scores for stroke after transcatheter aortic balloon-expandable valve implantation: an Italian Transcatheter Balloon-Expandable Valve Implantation Registry (ITER) sub-analysis.

OBJECTIVES: Stroke incidence after transcatheter aortic valve implantation (TAVI) still represents a concern. This multicentre study aimed at investigating the hypothesis that CHADS2 and CHA2DS2-VASc scores may be used to predict perioperative stroke after TAVI. METHODS: The Italian Transcatheter Balloon-Expandable Valve Implantation Registry (ITER) is a multicentre, prospective registry of patients undergoing balloon-expandable TAVI using Edwards Sapien and Sapien XT prosthesis between 2007 and 2012. The primary end-point of this study was the 30-day stroke rate. Secondary safety end-points were all the major adverse events based on Valve Academic Research Consortium (VARC-2) criteria. RESULTS: One thousand nine hundred and four patients were enrolled in the registry. Mean age was 81.6 ± 6.2 years and 1147 (60.2%) patients were female; mean CHADS2 and CHA2DS2-VASc scores were 2.2 ± 0.8 and 4.4 ± 1.1, respectively. Fifty-four (2.8%) patients had a stroke within 30 days. At multivariable logistic regression analysis, CHA2DS2-VASc (OR: 1.35, 95% CI: 1.03-1.78; P = 0.031) and previous cardiac surgery (OR: 1.96, 95% CI: 1.06-3.6; P = 0.033) but not CHADS2 (OR: 1.05, 95% CI: 0.76-1.44; P = 0.77) were found to be independent predictors of in-hospital stroke. A CHA2DS2-VASc score ≥5 was strongly related to the occurrence of in-hospital stroke (OR: 2.51, 95% CI: 1.38-4.57; P= 0.001). However, CHA2DS2-VASc score showed only poor accuracy for in-hospital stroke with a trend for better accuracy when compared with CHADS2 score (area under the curve: 0.61, 95% CI: 0.59-0.63 vs 0.51; 95% CI: 0.49-0.54, respectively, P = 0.092). CONCLUSIONS: In TAVI patients, CHA2DS2-VASc provided a strong correlation for in-hospital stroke but with low accuracy. Dedicated scores to properly tailor procedures and preventive strategies are needed.

Primary PCI in a patient with acute occlusion of native LAD beyond the LIMA graft anastomosis: first reported case, technical challenges and review of the literature.

We present a case of a man with an anterior STEMI due to acute occlusion of the LAD, distally to the anastomosis with LIMA graft. We describe our treatment strategy with primary PCI and the difficulties we encountered: insufficient length of balloon and stent shafts and need for deep intubation of the graft with the guiding catheter. The procedure was complicated by graft dissection that was successfully treated with a DES. Afterwards we successfully stented the culprit lesion. We discuss technical possibilities for overcoming such difficulties and present brief review of literature on STEMI in patients with previous CABG.