Transcatheter Aortic Valve Replacement in Degenerated Perceval Bioprosthesis: Clinical and Technical Aspects in 32 Cases.

BACKGROUND: Sutureless aortic bioprostheses are increasingly being used to provide shorter cross-clamp time and facilitate minimally invasive aortic valve replacement. As the use of sutureless valves has increased over the past decade, we begin to encounter their degeneration. We describe clinical outcomes and technical aspects in patients with degenerated sutureless Perceval (CorCym, Italy) aortic bioprosthesis treated with valve-in-valve transcatheter aortic valve replacement (VIV-TAVR). METHODS: Between March 2011 and March 2023, 1310 patients underwent aortic valve replacement (AVR) with Perceval bioprosthesis implantation. Severe bioprosthesis degeneration treated with VIV-TAVR occurred in 32 patients with a mean of 6.4 ± 1.9 years (range: 2-10 years) after first implantation. Mean EuroSCORE II was 9.5 ± 6.4% (range: 1.9-35.1%). RESULTS: Thirty of thirty-two (94%) VIV-TAVR were performed via transfemoral and two (6%) via transapical approach. Vascular complications occurred in two patients (6%), and mean hospital stay was 4.6 ± 2.4 days. At mean follow-up of 16.7 ± 15.2 months (range: 1-50 months), survival was 100%, and mean transvalvular pressure gradient was 18.7 ± 5.3 mmHg. CONCLUSION: VIV-TAVR is a useful option for degenerated Perceval and appears safe and effective. This procedure is associated with good clinical results and excellent hemodynamic performance in our largest single-center experience.

The Positive Impact of Early Frailty Levels on Mortality in Elderly Patients with Severe Aortic Stenosis Undergoing Transcatheter/Surgical Aortic Valve Replacement.

Background: Frailty is highly common in older patients (pts) undergoing transcatheter aortic valve replacement (TAVR), and it is associated with poor outcomes. The selection of patients who can benefit from this procedure is necessary and challenging. The aim of the present study is to evaluate outcomes in older severe aortic valve stenosis (AS) pts, selected by a multidisciplinary approach for surgical, clinical, and geriatric risk and referred to treatment, according to frailty levels. Methods: A total of 109 pts (83 ± 5 years; females, 68%) with AS were classified by Fried's score in pre-frail, early frail, and frail and underwent surgical aortic valve replacement SAVR/TAVR, balloon aortic valvuloplasty, or medical therapy. We evaluated geriatric, clinical, and surgical features and detected periprocedural complications. The outcome was all-cause mortality. Results: Increasing frailty was associated with the worst clinical, surgical, geriatric conditions. By using Kaplan-Meier analysis, the survival rate was higher in pre-frail and TAVR groups (p < 0.001) (median follow-up = 20 months). By using the Cox regression model, frailty (p = 0.004), heart failure (p = 0.007), EF% (p = 0.043), albumin (p = 0.018) were associated with all-cause mortality. Conclusions: According to tailored frailty management, elderly AS pts with early frailty levels seem to be the most suitable candidates for TAVR/SAVR for positive outcomes because advanced frailty would make each treatment futile or palliative.

Female gender and mortality in ST-segment-elevation myocardial infarction treated with primary PCI.

AIMS: To investigate gender difference in mortality among patients with ST-segment elevation myocardial infarction (STEMI) treated with primary percutaneous angioplasty (PPCI). METHODS: We analyzed data from the prospective registries of two hub PPCI centres over a 10-year period to assess the role of female gender as an independent predictor of both all-cause and cardiac death at 30 days and 1 year. To account for all confounding variables, a propensity score (PS)-adjusted multivariable Cox regression model and a PS-matched comparison between the male and female were used. RESULTS: Among 4370 consecutive STEMI patients treated with PPCI at participating centres, 1188 (27.2%) were women. The survival rate at 30 days and 1 year were significantly lower in women (Log-rank P-value < 0.001). At PS-adjusted multivariable Cox regression analysis, female gender was independently associated with an increased risk of 30-day all-cause death [hazard ratio (HR) = 2.09; 95% confidence interval (CI): 1.45-3.01, P < 0.001], 30-day cardiac death (HR = 2.03;95% CI:1.41-2.93, P < 0.001), 1-year all-cause death (HR = 1.45; 95% CI:1.16-1.82, P < 0.001) and 1-year cardiac death (HR = 1.51; 95% CI:1.15-1.97, P < 0.001). For the study outcome, we found a significant interaction of gender with the multivessel disease in females who were at increased risk of mortality in comparison with men in absence of multivessel disease. After the PS matching procedure, a subset of 2074 patients were identified. Women still had a lower survival rate and survival free from cardiac death rate both at 30-day and at 1-year follow-up. CONCLUSION: As compared with men, women with STEMI treated with PPCI have higher risk of both all-cause death and cardiac mortality at 30-day and 1-year follow-up.

Different inflammatory profile in young and elderly STEMI patients undergoing primary percutaneous coronary intervention (PPCI): Its influence on no-reflow and mortality.

BACKGROUND: Coronary no-reflow phenomenon in ST-segment elevation myocardial infarction (STEMI) is associated with a poor clinical prognosis. Although its pathophysiology is not fully elucidated, a deregulated systemic inflammatory response plays an important role. Specifically, the relationship between age-associated differences in inflammatory markers and either no-reflow or mortality in STEMI patients undergoing primary percutaneous coronary intervention (pPCI) has never been investigated. METHODS AND RESULTS: We retrospectively enrolled 625 consecutive STEMI patients undergoing pPCI for whom a complete laboratory inflammatory pattern was available. Routinely blood measured laboratory parameters were collected at the moment of admission. No reflow was defined as Thrombolysis in Myocardial Infarction (TIMI) flow-grade lower than 3. The population was divided into two groups using a cut-off centered at 65 years. Compared to younger patients, elderly patients had higher mean values of fibrinogen, brain natriuretic peptide (BNP), leukocytes, neutrophil-to-lymphocyte ratio (NLR), C reactive protein/albumin ratio (CAR). Conversely, lymphocyte count and albumin levels were higher in young patients. In elderly patients, the values of NLR, CAR as well as leukocytes, fibrinogen and neutrophils were associated with no-reflow, while in young patients only BNP value was associated. At multivariate Cox regression analysis, only BNP and NLR resulted as independent predictors of all-cause mortality in the whole population and in elderly patients. CONCLUSIONS: Elderly STEMI patients on admission had a higher acute pro-inflammatory profile than young patients, associated to coronary no-reflow and mortality outcome. These results suggest that a different therapeutic approach between elderly and young STEMI patients should be agreed.

Usefulness of Triiodothyronine Replacement Therapy in Patients With ST Elevation Myocardial Infarction and Borderline/Reduced Triiodothyronine Levels (from the THIRST Study).

The aim of the study was to investigate whether TH replacement therapy is safe and impact infarct size, left ventricular (LV) volumes and function in patients with acute myocardial infarction (AMI) and low T3 syndrome (LT3S). Thirty-seven AMI/LT3S patients were randomly treated or untreated with liothyronine (T3) therapy (maximum dosage 15 mcg/m2/die) in addition to standardized treatment (T3-treated group, n = 19; untreated group, n = 18). TH and thyroxine (TSH) during hospital stay and at 1-month and 6 months were evaluated. At discharge and at 6 months LV volumes, ejection fraction, wall motion score index (WMSI) and infarct extent were measured by cardiac MR. T3-treated patients had a significant increase in fT3 (p = 0.003 and p <0.001) at discharge and 1-month. These patients had no signs or symptoms of hyperthyroidism or arrhythmias. At follow-up, there was a significant reduction in WMSI in both groups (T3-treated group: Δ = -0.12, p = 0.001; untreated group: Δ = -0.04, p = 0.04) and the difference value (discharge/follow-up) was significantly higher in T3-treated group than in untreated group (mean difference between groups = 0.08, 95% confidence interval [CI]: 0.01 to 0.15, p = 0.05). Also, stroke volume increased significantly in the T3-treated group (Δ = 3.4, 95% CI: 0.8 to 6, p <0.01) at follow-up. In conclusion, this is the first pilot experience in which T3 replacement therapy resulted safe and able to improve regional dysfunction in patients with STEMI/LT3S.

Development and validation of a risk stratification score for new-onset atrial fibrillation in STEMI patients undergoing primary percutaneous coronary intervention.

AIM: New-onset atrial fibrillation (NOAF) is a complication not infrequent in patients with acute ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (pPCI) and has been associated with worse in-hospital and long-term prognosis. We aimed to develop and validate a risk score based on common clinical risk factors and routine blood biomarkers to assess the early incidence of NOAF post-pPCI, before discharge. METHODS: The risk score for NOAF occurrence during hospitalisation (about 5 days) was developed in a cohort of 1135 consecutive STEMI patients undergoing pPCI while was externally validated in a temporal cohort of 771 STEMI patients. Biomarkers and clinical variables significantly contributing to predicting NOAF were assessed by multivariate Cox-regression analysis. RESULTS: Independent predictors of NOAF were age ≥80 years (6.97 [3.40-14.30], hazard ratio [95% CI], P < .001), leukocyte count > 9.68 × 103 /µL (2.65 [1.57-4.48], P < .001), brain natriuretic peptide (BNP) > 80 ng/L (2.37 [1.13-4.95], P = .02) and obesity (2.07 [1.09-3.92], P = .03). By summing the hazard ratios of these predictors we derived the ALBO (acronym derived from: Age, Leucocyte, BNP and Obesity) risk score which yielded high C-statistics in both the derivation (0.734 [0.675-0.793], P < .001) and validation cohort (0.76 [0.688-0.831], P < .001). In both cohorts, using Kaplan-Meier risk analysis, the ALBO score identified a tertile of patients at highest risk (ALBO >4 points), with percentages of NOAF incidence of 30.8% and 27.4% in the derivation and validation cohort, respectively. CONCLUSION: The ALBO risk score, comprising biomarkers and clinical variables that can be assessed in hospital setting, could help to identify high-risk patients for NOAF after pPCI so that a prompter action can be taken.

Transapical transcatheter mitral valve-in-valve implantation versus minimally invasive surgery for failed mitral bioprostheses.

OBJECTIVES: The aim of this study was to compare early outcomes and survival of patients undergoing minimally invasive mitral valve replacement through a right anterior minithoracotomy (MIMVR) versus patients undergoing transcatheter transapical mitral valve-in-valve (M-VIV) implantation for a failed mitral bioprostheses. METHODS: From 2005 to 2015, 61 patients with a failed mitral bioprosthesis underwent either MIMVR ( n = 40 patients, 65.6%) or M-VIV implantation ( n = 21, 34.4%) at our institution. The groups were compared in terms of early outcomes and survival rates. Treatment selection bias was controlled by a propensity score and was included along with the comparison variable in the multivariable analyses of outcome. RESULTS: Patients with M-VIV implantation were older ( P = 0.03), had more pulmonary hypertension ( P = 0.02) and a higher EuroSCORE ( P = 0.001). In-hospital mortality was 7.5% ( n = 3) in the MIMVR group and 4.7% ( n = 1) in the M-VIV group [odds ratio (OR) = 2.46; P = 0.512]. Incidence of stroke was 12.5% ( n = 5) in the MIMVR group vs 4.7% ( n = 1) in the M-VIV group (OR = 0.887; P = 0.935). No significant differences were noted in postprocedural complications, even after adjusting the results for the propensity score. M-VIV patients had shorter stays in the intensive care unit and in the hospital ( P = 0.02). In the M-VIV group, 28% ( n = 7) had less than mild paravalvular leakage, whereas no patients had mild paravalvular leakage in the MIMVR group ( P < 0.001). Finally, the 2-year survival rates were 86 ± 1% vs 87 ± 1% in patients undergoing MIMVR compared with those undergoing M-VIV implantation, respectively ( P = 0.1). CONCLUSIONS: In selected patients, M-VIV can be performed safely with results comparable with those of surgical therapy.

Left atrial appendage occlusion in high-risk patients with non-valvular atrial fibrillation.

OBJECTIVE: Percutaneous left atrial appendage (LAA) occlusion has been developed as a viable option for stroke and thromboembolism prevention in patients with non-valvular atrial fibrillation (NVAF) and at high risk for cerebral cardioembolic events. Data on device implantation and long-term follow-up from large cohorts are limited. METHODS: 110 consecutive patients with NVAF and contraindications to oral anticoagulants (OACs) underwent LAA occlusion procedures and achieved a longer than 1 year follow-up. All patients were enrolled in a prospective registry. Procedures were performed using the Amplatzer Cardiac Plug or Amulet guided by fluoroscopy and intracardiac echocardiography. RESULTS: Mean age of the population was 77±6 years old; 68 were men. Atrial fibrillation was paroxysmal in 20%, persistent in 15.5% and permanent in 64.5% of cases, respectively. Mean CHA2DS2-VASc and HAS-BLED scores were 4.3±1.3 and 3.4±1, respectively. Technical success (successful deployment and implantation of device) was achieved in 100% of procedures. Procedural success (technical success without major procedure-related complications) was achieved in 96.4%, with a 3.6% rate of major procedural complications (three cases of pericardial tamponade requiring drainage and one case of major bleeding). Mean follow-up was 30±12 months (264 patient-years). Annual rates for ischaemic stroke and for other thromboembolic events were respectively 2.2% and 0%, and annual rate for major bleeding was 1.1%. CONCLUSIONS: Our data suggest LAA occlusion in high-risk patients with NVAF not suitable for OACs is feasible and associated with low complication rates as well as low rates of stroke and major bleeding at long-term follow-up.

Transapical Transcatheter Valve-in-Valve Implantation for Failed Mitral Bioprostheses: Gradient, Symptoms, and Functional Status in 18 High-Risk Patients Up to 5 Years.

BACKGROUND: The recourse to mitral valve-in-valve implantation is expected to rise consistently owing to the increasing use of bioprostheses and to the risks related to redo valve replacement. However, there is concern that the excellent early results of mitral valve-in-valve could be nullified by the development of significant gradients. We report our experience with mitral valve-in-valve implantation, with particular emphasis on the midterm follow-up. METHODS: Eighteen patients underwent mitral valve-in-valve implantation at our institution. The mean Society of Thoracic Surgeons score was 10.3. All patients were heavily symptomatic. The mechanisms of bioprosthesis failure were stenosis (3 patients), regurgitation (4 patients) or mixed (11 patients). The mean transprosthetic gradient was 12.8 ± 5.7 mm Hg. All the procedures were transapical. Balloon predilation was never used. RESULTS: In the first patient, the transcatheter valve embolized in the ventricle. The patient died 2 days later of multiorgan failure. There were no other hospital deaths. Four patients died of pneumonia, endocarditis, lung cancer, and stroke at 1, 8, 18, and 46 months, postoperatively. The mean gradient at discharge was 5.1 ± 2.3 mm Hg. At follow-up (median 27 months), all surviving patients were in New York Heart Association functional class II or less. The mean transprosthetic gradient was 7 ± 1.8 mm Hg, and 1 patient had a gradient more than 10 mm Hg. CONCLUSIONS: Mitral valve-in-valve implantation allows good clinical and hemodynamic results. In our series, the appearance of a significant gradient at follow-up was not associated with echocardiographic signs of structural deterioration, and was possibly related to the size of the transcatheter and recipient valve.

Self-expanding stent for complex percutaneous coronary interventions: A real life experience.

AIM: Self-expanding stents represent a re-emerging option for percutaneous coronary interventions. Their application covers a wide spectrum of angiographic situations, i.e., coronary bifurcations, acute coronary syndromes with large thrombotic burden and stenosis of ectatic coronaries. We review our experience with self-expanding stents for different clinical and angiographic indications, with long clinical follow-up. METHODS: From 2011 to 2013 we used self-expanding STENTYS® stents in 40 consecutive patients followed-up for death from any cause and from cardiovascular cause, myocardial infarction, target lesion revascularization (TLR), stent thrombosis (mean 21±13months). We also revised rate of procedural outcomes, acute stent thrombosis and TLR in patients treated with conventional stents for similar clinical/angiographic situations, in the same period at our institution. RESULTS: We identified three anatomical settings of STENTYS® use: coronary bifurcations with proximal/distal main branch diameter discrepancy (55% of cases), massive thrombotic burden in the setting of acute coronary syndrome (35% of cases) and stenosis of ectatic coronaries (15%). We observed one death related to acute heart failure and 1 case (2.5%) of acute stent thrombosis (2.5% in the control group). During follow-up 2 cases of stent restenosis leading to TLR (5%) occurred (6.25% in the control group). CONCLUSIONS: According to our real life experience, self-expanding STENTYS® stents appear to be an effective tool for different angiographic situations in which they may be preferable to balloon-expandable stents, showing a low rate of complications and good results at long term follow-up.

Drug eluting balloon: a multipurpose tool for coronary revascularization with optimal long-term follow-up results.

AIMS: This study aimed to evaluate safety and efficacy of drug-coated balloon (DCB) at long-term follow-up; a large series of real-life patients underwent revascularization with DCB for a wide spectrum of clinical and angiographic situations. METHODS AND RESULTS: One hundred ten patients underwent percutaneous revascularization using paclitaxel eluting balloon (Sequent Please, Braun, Germany). End-points were major adverse cardiac events (MACE; all-cause death, myocardial infarction [MI], target vessel revascularisation [TVR], and vessel thrombosis). DCB were used for stable angina (58%), unstable angina/nonST elevation MI (31%) and ST elevation MI (11%). DCB were used for in-stent restenosis (61%), small vessel disease (25%), with bare metal stent (BMS) to avoid long dual antiplatelet therapy (10%) or for impossibility to place a stent (4%). Cumulative MACE at follow-up (median 23 months, IQR 13-32) was 12.7%, with 8.2% all-cause death (1 fatal MI), 4.5% TVR, 3.6% TLR, and no vessel thrombosis. Three of four TLRs occurred in patients who received DEB for DES restenosis. CONCLUSIONS: DCB are a very effective tool for a variety of clinical and angiographic situations. DCB use seems to be affected by a low rate of complications and adequate results at long-term follow-up.

Periprocedural intracardiac echocardiography for left atrial appendage closure: a dual-center experience.

OBJECTIVES: This dual-center study sought to demonstrate the utility and safety of intracardiac echocardiography (ICE) in providing adequate imaging guidance as an alternative to transesophageal echocardiography (TEE) during Amplatzer Cardiac Plug device implantation. BACKGROUND: Over 90% of intracardiac thrombi in atrial fibrillation originate from the left atrial appendage (LAA). Patients with contraindications to anticoagulation are potential candidates for LAA percutaneous occlusion. TEE is typically used to guide implantation. METHODS: ICE-guided percutaneous LAA closure was performed in 121 patients to evaluate the following tasks typically achieved by TEE: assessment of the LAA dimension for device sizing; guidance of transseptal puncture; verification of the delivery sheath position; confirmation of location and stability of the device before and after release and continuous monitoring to detect procedural complications. In 51 consecutive patients, we compared the measurements obtained by ICE and fluoroscopy to choose the size of the device. RESULTS: The device was successfully implanted in 117 patients, yielding a technical success rate of 96.7%. Procedural success was achieved in 113 cases (93.4%). Four major adverse events (3 cardiac tamponades and 1 in-hospital transient ischemic attack) occurred. There was significant correlation in the measurements for device sizing assessed by angiography and ICE (r = 0.94, p < 0.0001). CONCLUSIONS: ICE imaging was able to perform the tasks typically provided by TEE during implantation of the Amplatzer Cardiac Plug device for LAA occlusion. Therefore, we provide evidence that the use of ICE offered accurate measurements of LAA dimension in order to select the correct device sizes.

[Venous graft in-stent restanosis: diagnostic and treatment evolution]. / Multiple restenosi intrastent di graft venoso: evoluzione diagnostica e terapeutica.

This is the case of a 77 year-old man with previous coronary by-pass grafting. After the occlusion of the saphenous vein graft to marginal branch, corrected by angioplasty and stenting with a bare metal stent (BMS), during the next 4 years he experienced multiple further episodes of in-stent restenosis of the first BMS. Angioplasty was performed each time. After 4 months since the last procedure, he had new episode of unstable angina. An EKG-gated, 64-row multislice CT (MSCT) examination was performed to evaluate the venous graft lumen, showing high-grade in-stent restenosis. Angiography confirmed the MSCT diagnosis, thus he underwent angioplasty and stenting with a drug eluting stent (DES). Thereafter, he remained stable for 4 years, when new anginal episodes led to a further coronary angiogram, showing progression of the atherosclerosic disease at the proximal and distal anastomosis of the venous graft; however, the previous implanted DES was patent. In the complex management of venous grafts restenosis, MSCT can be useful to help in detecting obstructive bypass graft disease. When revascularization is needed, DES have shown to be superior compared to BMS.

Endovascular treatment of acute thoracic aortic syndromes with a proximal landing zone extension strategy: procedural and follow-up results.

PURPOSE: To report the procedural and long-term follow-up data (mean, 43 ± 29 months; range, 12-90 months) of endovascular stent grafting (ESG) of acute thoracic aortic syndromes (ATAS) with a proximal landing zone extension strategy. METHODS: From November 1999 to May 2008, 26 patients (25 males, 1 female; mean age, 57.9 ± 17 years) with ATAS underwent ESG at our institution. Underlying pathologies were: penetrating aortic ulcer (n=7); rupture of a descending aorta aneurysm (n=5), post-traumatic false aneurysm (n=5); acute type B dissection (n=6) and traumatic descending aorta transection (n=3). RESULTS: ESG was performed successfully in all patients. In 5 patients (19%), an extra-anatomic revascularization of the supra-aortic vessels was performed. In 19 patients (73%), overstenting of the left subclavian artery, without preliminary revascularization, was performed. The mean proximal landing zone length was 57 ± 19 mm. No intraprocedural deaths occurred; 3 patients died postoperatively (1 from an unrelated cause, 1 from a myocardial infarction and 1 for the sequelae of an ischemic stroke). One patient underwent cardiac surgery for post-procedural retrograde type-A dissection. Follow up involved a computed tomography (CT) scan at 1, 3, 6 and 12 months, then yearly thereafter. At follow up, no deaths or major complications occurred. The CT scans revealed 1 small type-IB endoleak at 1 year. CONCLUSION: In ATAS patients treated with ESG, the extension of the proximal landing zone, despite the need of subclavian coverage or hybrid procedures, is associated with an immediate procedural outcome and low morbidity at follow-up.