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1.
Catheter Cardiovasc Interv ; 100(1): 114-119, 2022 07.
Article in English | MEDLINE | ID: mdl-35557027

ABSTRACT

Transcatheter aortic valve implantation (TAVI) has proved beneficial in patients with severe aortic stenosis, especially when second-generation devices are used. We aimed at reporting our experience with Navitor, a third-generation device characterized by intrannular, large cell, and cuffed design, as well as high deliverability and minimization of paravalvular leak. Between June and December 2021, a total of 39 patients underwent TAVI with Navitor, representing 20% of all TAVI cases. Mean age was 80.0 ± 6.7 years, and 14 (36.8%) women were included. Severe aortic stenosis was the most common indication to TAVI (37 [97.4%] cases), whereas 2 (5.3%) individuals were at low surgical risk. Device and procedural success was obtained in all patients, with a total hospital stay of 6.6 ± 4.5 days. One (2.9%) patient required permanent pacemaker implantation, but no other hospital events occurred. At 1-month follow-up, a cardiac death was adjudicated in an 87-year-old man who had been at high surgical risk. Echocardiographic follow-up showed no case of moderate or severe aortic regurgitation, with mild regurgitation in 18 (47%), and none or trace regurgitation in 20 (53%). The Navitor device, thanks to its unique features, is a very promising technology suitable to further expand indications and risk-benefit profile of TAVI.


Subject(s)
Aortic Valve Stenosis , Heart Valve Prosthesis , Transcatheter Aortic Valve Replacement , Aged , Aged, 80 and over , Aortic Valve/diagnostic imaging , Aortic Valve/surgery , Aortic Valve Stenosis/diagnostic imaging , Aortic Valve Stenosis/surgery , Female , Humans , Male , Transcatheter Aortic Valve Replacement/adverse effects , Treatment Outcome
2.
Ann Vasc Surg ; 64: 151-156.e2, 2020 Apr.
Article in English | MEDLINE | ID: mdl-31629846

ABSTRACT

BACKGROUND: The optional periprocedural antithrombotic management for carotid artery stenting (CAS) is still debated. METHODS: We aimed to compare the procedural and 1-month outlook of patients undergoing CAS with tirofiban as parenteral antiplatelet therapy. We retrospectively compared patients receiving tirofiban during CAS versus those undergoing CAS without tirofiban, using propensity score matching. Ancillary antithrombotic therapy included in all patients aspirin, clopidogrel, and unfractioned heparin. The primary outcome was the change in serum troponin from baseline to postprocedural peak levels. A total of 30 patients undergoing CAS were included, 15 receiving tirofiban on top of heparin and dual oral antiplatelet therapy (DAPT) and 15 receiving only heparin and DAPT. Bail-out use of tirofiban was an exclusion criterion. RESULTS: Baseline troponin was 3.00 (0.06; 5.20) ng/mL in the tirofiban group vs. 4.6 (0.02; 13.10) ng/mL in the no-tirofiban group (P = 0.229), and postprocedural peak 3.5 (0.06; 5.50) ng/mL vs. 6.30 (0.09; 28.40) ng/mL (P = 0.191). Peak-baseline difference in troponin was lower in the tirofiban group than in the no-tirofiban group: 0.3 (0.00; 1.7) ng/mL vs. 1.3 (0.01; 10.00) ng/mL (P = 0.044); the relative peak-baseline change in troponin was analogously different: 24.3% (0%; 44.7%) vs. 50% (21.3%; 80.0%) (P = 0.039). No case of death, myocardial infarction, stroke, or transient ischemic attack occurred during in-hospital stay or at 1-month follow-up. CONCLUSIONS: Tirofiban during CAS might provide periprocedural myocardial protection and reduce myocardial injury as determined by serial troponin measurements.


Subject(s)
Carotid Artery Diseases/therapy , Endovascular Procedures/instrumentation , Heart Diseases/prevention & control , Platelet Aggregation Inhibitors/therapeutic use , Stents , Tirofiban/therapeutic use , Troponin/blood , Aged , Anticoagulants/therapeutic use , Biomarkers/blood , Carotid Artery Diseases/diagnostic imaging , Databases, Factual , Dual Anti-Platelet Therapy , Endovascular Procedures/adverse effects , Female , Heart Diseases/blood , Heart Diseases/diagnosis , Heart Diseases/etiology , Heparin/therapeutic use , Humans , Male , Platelet Aggregation Inhibitors/adverse effects , Propensity Score , Retrospective Studies , Risk Assessment , Risk Factors , Time Factors , Tirofiban/adverse effects , Treatment Outcome
7.
Catheter Cardiovasc Interv ; 88(3): 490-3, 2016 Sep.
Article in English | MEDLINE | ID: mdl-26424553

ABSTRACT

Transcatheter aortic valve replacement (TAVR), also known as transcatheter aortic valve implantation (TAVI), is being used with increasing frequency in patients with severe aortic stenosis at high or prohibitive surgical risk. A number of devices are becoming available for TAVR, and competence in using them is mandatory to maximize the safety and efficacy of TAVR, while individualizing device selection in keeping with patient features. The ACURATE TF is a novel promising device for transfemoral TAVR. However, its peculiar features may require additional maneuvers in case of complications. We hereby report the case of a patient undergoing transfemoral TAVR with the ACURATE TF device, in whom lowermost deployment was complicated by massive aortic regurgitation. With two separate remedial actions, the balloon pull and lasso techniques, we were able to pull back the device and significantly reduce post-TAVR aortic regurgitation. Awareness of this complication and the possible use of these two techniques may increase the safety and efficacy of TAVR with this and other new devices. © 2015 Wiley Periodicals, Inc.


Subject(s)
Aortic Valve Insufficiency/therapy , Aortic Valve Stenosis/therapy , Balloon Valvuloplasty , Cardiac Catheterization/instrumentation , Heart Valve Prosthesis Implantation/instrumentation , Heart Valve Prosthesis , Aged , Aortic Valve Insufficiency/diagnostic imaging , Aortic Valve Insufficiency/etiology , Aortic Valve Insufficiency/physiopathology , Aortic Valve Stenosis/diagnostic imaging , Aortic Valve Stenosis/physiopathology , Cardiac Catheterization/methods , Catheterization, Peripheral , Femoral Artery/diagnostic imaging , Heart Valve Prosthesis Implantation/methods , Humans , Male , Prosthesis Design , Punctures , Radiography, Interventional , Severity of Illness Index , Treatment Outcome
8.
Heliyon ; 10(15): e35341, 2024 Aug 15.
Article in English | MEDLINE | ID: mdl-39170431

ABSTRACT

SARS-CoV-2 viral-derived particles have been proposed to have a causal role in tissue inflammation. Macrophage is the culprit cell in the pathogenesis of destructive inflammatory response to the SARS-CoV-2 virus. We investigated whether the spike protein might play a role in perturbing the physiological process of resolution of inflammation. Using an in vitro model of M2 polarized macrophages, we found that recombinant spike protein produced typical M1 morphological features in these alternative differentiated cells. In the presence of spike, M2-macrophages lose their elongated morphology, become rounded and acquire a strong capability to stimulate lymphocyte activation and proliferation. Moreover, in M2 macrophages, spike activated the signal transducer and activator-1 (STAT1) the pivotal mediator of pro-inflammatory macrophages. We observed STAT1 activation also in endothelial cells cultured with recombinant spike, accompanied by Bax upregulation and cell death. Blockade of beta3 integrin with the RGD mimetic tirofiban reverted the spike-induced costimulatory effects on M2 macrophages. Also, tirofiban counteracted STAT1 and Bax activation in endothelial cells cultured with spike and reduced endothelial cell death. In conclusion, we found that some proinflammatory effects of the spike protein can involve the integrin pathway and provide elements supporting use of RGD mimetics against SARS-Cov-2.

9.
Minerva Med ; 2024 Jun 13.
Article in English | MEDLINE | ID: mdl-38867594

ABSTRACT

Cardiovascular disease remains decade after decade a leading cause of mortality, morbidity and resource use globally as well as locally. We have had the opportunity of being involved in several iterative breakthroughs in invasive cardiovascular procedures, ranging from the advent of coronary stents to transcatheter mitral valve repair. Building up such extensive clinical and research experience, we hereby present 25 years of cardiovascular interventions at Pineta Grande Hospital and Casa di Salute S. Lucia, respectively in Castel Volturno, and S. Giuseppe Vesuviano, both in the Italian Campania region, where the same team of interventional cardiologists has managed to adopt and master several cardiovascular innovations for the benefit of thousands of patients. Our experience showcases the evolution of invasive cardiology, especially in diagnostic and therapeutic practices. Key highlights include advancements in coronary procedures, with the introduction of bare-metal stents, drug-eluting stents and drug-coated balloons, despite the setback of bioresorbable vascular scaffolds, as well as transcatheter aortic valve implantation and innovative approaches to mitral regurgitation. Furthermore, this overview scrutinizes procedural challenges, patient outcomes, and quality of life improvements, providing a rich tapestry of clinical experiences and research insights. It serves as a testament to the dynamic nature of interventional cardiology, offering a forward-looking perspective on future trends and technologies. We hope that this overview will prove an informative and insightful read for those seeking to understand the intricate journey of invasive cardiovascular care over the past decades and its trajectory into the future.

10.
Clin Res Cardiol ; 113(1): 68-74, 2024 Jan.
Article in English | MEDLINE | ID: mdl-37294310

ABSTRACT

AIM: Transcatheter aortic valve implantation (TAVI) is a mainstay in the management of severe aortic stenosis in patients with intermediate to prohibitive surgical risk. When a single TAVI device fails and cannot be retrieved, TAVI-in-TAVI must be performed acutely, but outcomes of bailout TAVI-in-TAVI have been incompletely appraised. We aimed at analyzing patient, procedural and outcome features of patients undergoing bailout TAVI-in-TAVI in a multicenter registry. METHODS: Details of patients undergoing bailout TAVI-in-TAVI, performed acutely or within 24 h of index TAVI, in 6 international high-volume institutions, were collected. For every case provided, 2 same-week consecutive controls (prior TAVI, and subsequent TAVI) were provided. Outcomes of interest were procedural and long-term events, including death, myocardial infarction, stroke, access site complication, major bleeding, and reintervention, and their composite (i.e. major adverse events [MAE]). RESULTS: A total of 106 patients undergoing bailout TAVI-in-TAVI were included, as well as 212 controls, for a total of 318 individuals. Bailout TAVI-in-TAVI was less common in younger patients, those with higher body mass index, or treated with Portico/Navitor or Sapien devices (all p < 0.05). Bailout TAVI-in-TAVI was associated with higher in-hospital rates of death, emergency surgery, MAE, and permanent pacemaker implantation (all p < 0.05). Long-term follow-up showed that bailout TAVI-in-TAVI was associated with higher rates of death and MAE (both < 0.05). Similar findings were obtained at adjusted analyses (all p < 0.05). However, censoring early events, outlook was not significantly different when comparing the two groups (p = 0.897 for death, and p = 0.645 for MAE). CONCLUSIONS: Bail-out TAVI-in-TAVI is associated with significant early and long-term mortality and morbidity. Thus, meticulous preprocedural planning and sophisticated intraprocedural techniques are of paramount importance to avoid these emergency procedures.


Subject(s)
Aortic Valve Stenosis , Heart Valve Prosthesis , Stroke , Transcatheter Aortic Valve Replacement , Humans , Transcatheter Aortic Valve Replacement/methods , Aortic Valve Stenosis/surgery , Treatment Outcome , Stroke/etiology , Registries , Aortic Valve/surgery , Risk Factors
11.
Clin Res Cardiol ; 113(1): 86-93, 2024 Jan.
Article in English | MEDLINE | ID: mdl-37391628

ABSTRACT

AIM: Transcatheter aortic valve implantation (TAVI) is a mainstay in the management of severe aortic valve stenosis in elderly patients, but there is uncertainty on their long-term effectiveness. We aimed to assess the long-term outcome of patients undergoing TAVI with the Portico valve. METHODS: We retrospectively collected the data on patients in whom TAVI with Portico was attempted from 7 high-volume centres. Only patients theoretically eligible for 3 or more years of follow-up were included. Clinical outcomes, including death, stroke, myocardial infarction, reintervention for valve degeneration and hemodynamic valve performance were systematically assessed. RESULTS: A total of 803 patients were included, with 504 (62.8%) women, mean age of 82 years, median EuroSCORE II of 3.1%, and 386 (48.1%) subjects at low/moderate risk. The median follow-up was 3.0 years (3.0; 4.0). The composite of death, stroke, myocardial infarction, and reintervention for valve degeneration occurred in 37.5% (95% confidence interval: 34.1-40.9%), with all-cause death in 35.1% (31.8-38.4%), stroke in 3.4% (1.3-3.4%), myocardial infarction in 1.0% (0.3-1.5%), and reintervention for valve degeneration in 1.1% (0.6-2.1%). The mean aortic valve gradient at follow-up was 8.1 ± 4.6 mmHg, and at least moderate aortic regurgitation was present in 9.1% (6.7-12.3%). Independent predictors of major adverse events or death were: peripheral artery disease, chronic obstructive pulmonary disease, estimated glomerular filtration rate, atrial fibrillation, prior pacemaker implantation, EuroSCORE II, and reduced left ventricular ejection fraction (all p < 0.05). CONCLUSIONS: Portico use is associated with favorable long-term clinical outcomes. Clinical outcomes were largely impacted by baseline risk factors and surgical risk.


Subject(s)
Aortic Valve Stenosis , Heart Valve Prosthesis , Myocardial Infarction , Stroke , Transcatheter Aortic Valve Replacement , Humans , Female , Aged , Aged, 80 and over , Male , Transcatheter Aortic Valve Replacement/adverse effects , Aortic Valve/surgery , Retrospective Studies , Stroke Volume , Treatment Outcome , Ventricular Function, Left , Aortic Valve Stenosis/surgery , Stroke/etiology
12.
Cardiovasc Revasc Med ; 62: 40-47, 2024 May.
Article in English | MEDLINE | ID: mdl-38135568

ABSTRACT

BACKGROUND: Vascular complications (VCs) still represent one of the principal concerns of trans-femoral trans-catheter aortic valve replacement (TF-TAVR). New-generation devices can minimize such complications but the arterial access management is left to the operator's choice. This study aims to describe the rate of VCs in a contemporary cohort of patients undergoing TAVR with new-generation devices and to determine whether an ultrasound-guided (USG) vs. a fluoroscopy-guided (FG) femoral access management has an impact on their prevention. METHODS: This is a prospective, observational, multicenter study. Consecutive patients undergoing TAVR with new-generation devices were analyzed from January 2022 to October 2022 in five tertiary care centers. Femoral accesses were managed according to the operator's preferences. All the patients underwent a pre-discharge peripheral ultrasound control. VCs and bleedings were the main endpoints of interest. RESULTS: A total of 458 consecutive patients were enrolled (274 in the USG group and 184 in the FG group). VCs occurred in 6.5 % of the patients (5.2 % minor and 1.3 % major). There was no difference between the USG and the FG groups in terms of any VCs (7.3 % vs. 5.4 %; p = 0.4), or any VARC-3 bleedings (6.9 % vs 6 %, p = 0.9). At logistic regression analysis, the two guidance strategies did not result as predictors of VCs (odds Ratio 0.8, 95 % Confidence Interval 0.46-1.4; P = 0.4). CONCLUSIONS: In a contemporary cohort of patients undergoing TAVR with new-generation devices, the occurrence of VCs is low and mostly represented by minor VCs. USG and FG modalities did not affect the rate of VCs.


Subject(s)
Aortic Valve , Catheterization, Peripheral , Femoral Artery , Punctures , Radiography, Interventional , Registries , Transcatheter Aortic Valve Replacement , Ultrasonography, Interventional , Humans , Femoral Artery/diagnostic imaging , Male , Female , Prospective Studies , Transcatheter Aortic Valve Replacement/adverse effects , Transcatheter Aortic Valve Replacement/instrumentation , Aged, 80 and over , Aged , Fluoroscopy , Treatment Outcome , Catheterization, Peripheral/adverse effects , Catheterization, Peripheral/instrumentation , Aortic Valve/surgery , Aortic Valve/diagnostic imaging , Aortic Valve/physiopathology , Risk Factors , Radiography, Interventional/adverse effects , Heart Valve Prosthesis , Time Factors , Aortic Valve Stenosis/surgery , Aortic Valve Stenosis/diagnostic imaging , Prosthesis Design
13.
J Am Heart Assoc ; 13(10): e033605, 2024 May 21.
Article in English | MEDLINE | ID: mdl-38742523

ABSTRACT

BACKGROUND: Minimally invasive mitral valve repair has a favorable risk-benefit profile in patients with significant de novo mitral regurgitation. Its role in patients with prior mitral valve repair is uncertain. We aimed to appraise the outcome of patients undergoing transcatheter edge-to-edge repair (TEER) with prior transcatheter or surgical mitral valve repair (SMVR). METHODS AND RESULTS: We queried the Italian multicenter registry on TEER with MitraClip, distinguishing naïve patients from those with prior TEER or (SMVR). Inhospital and long-term clinical/echocardiographic outcomes were appraised. The primary outcome was the occurrence of death or rehospitalization for heart failure. A total of 2238 patients were included, with 2169 (96.9%) who were naïve to any mitral intervention, 29 (1.3%) with prior TEER, and 40 (1.8%) with prior SMVR. Several significant differences were found in baseline clinical and imaging features. Respectively, device success was obtained in 2120 (97.7%), 28 (96.6%), and 38 (95.0%, P=0.261) patients; procedural success in 2080 (95.9%), 25 (86.2%), and 38 (95.0%; P=0.047); and inhospital death in 61 (2.8%), 1 (3.5%), and no (P=0.558) patients. Clinical follow-up after a mean of 14 months showed similar rates of death, cardiac death, rehospitalization, rehospitalization for heart failure, and their composite (all P>0.05). Propensity score-adjusted analysis confirmed unadjusted analysis, with lower procedural success for the prior TEER group (odds ratio, 0.28 [95% CI, 0.09-0.81]; P=0.019) but similar odds ratios and hazard ratios for all other outcomes in the naïve, TEER, and SMVR groups (all P>0.05). CONCLUSIONS: In carefully selected patients, TEER can be performed using the MitraClip device even after prior TEER or SMVR.


Subject(s)
Cardiac Catheterization , Heart Valve Prosthesis Implantation , Mitral Valve Insufficiency , Mitral Valve , Registries , Humans , Mitral Valve Insufficiency/surgery , Mitral Valve Insufficiency/mortality , Mitral Valve Insufficiency/physiopathology , Mitral Valve Insufficiency/diagnostic imaging , Male , Female , Aged , Cardiac Catheterization/instrumentation , Cardiac Catheterization/methods , Mitral Valve/surgery , Mitral Valve/diagnostic imaging , Mitral Valve/physiopathology , Heart Valve Prosthesis Implantation/instrumentation , Heart Valve Prosthesis Implantation/adverse effects , Heart Valve Prosthesis Implantation/methods , Italy/epidemiology , Aged, 80 and over , Patient Readmission/statistics & numerical data , Treatment Failure , Heart Valve Prosthesis , Mitral Valve Annuloplasty/instrumentation , Mitral Valve Annuloplasty/adverse effects , Treatment Outcome , Time Factors , Risk Factors , Heart Failure/mortality , Heart Failure/physiopathology , Heart Failure/surgery
14.
J Invasive Cardiol ; 36(8)2024 Aug.
Article in English | MEDLINE | ID: mdl-38598251

ABSTRACT

OBJECTIVES: Transcatheter edge-to-edge repair (TEER) has become an established minimally invasive treatment for significant mitral regurgitation. Ongoing refinements and the availability of different clipping devices have expanded the indications for and effectiveness of TEER, but comprehensive comparative data on this issue are lacking. In this study, we compared NT, NTr, and XTr MitraClip devices (Abbot) for TEER. METHODS: Details on patient, imaging, and procedural details, as well as short- and long-term outcomes, were sought from a national prospective clinical registry on TEER with MitraClip. The primary outcome of interest was discharge after procedural success without major clinical complications. RESULTS: A total of 2236 patients were included, 1228 (54.9%) in whom NT implantation only was attempted, 233 (10.4%) in whom NTr but not XTr implantation was attempted, and 775 (34.7%) in whom XTr implantation was attempted. Clinical and imaging features differed substantially across the groups, reflecting expanding indications with NTr and XTr devices. In-hospital outcomes were largely similar among the 3 groups, including death. Long-term unadjusted estimates of effect showed significant differences in several outcomes, including death, rehospitalization, and their composite, which demonstrated that NT was associated with more unfavorable outcomes compared with the other devices (all P less than .05). However, most differences depended on baseline features, as adjusted analysis showed no significant differences for early as well as long-term outcomes, including long-term death, rehospitalization, and their composite (all P greater than .05). CONCLUSIONS: New-generation MitraClip devices are associated with favorable procedural and clinical outcomes, despite being used in patients with more adverse features, when compared with patients treated with previous devices.


Subject(s)
Cardiac Catheterization , Mitral Valve Insufficiency , Mitral Valve , Humans , Mitral Valve Insufficiency/surgery , Mitral Valve Insufficiency/diagnosis , Female , Male , Cardiac Catheterization/methods , Aged , Mitral Valve/surgery , Mitral Valve/diagnostic imaging , Treatment Outcome , Heart Valve Prosthesis Implantation/methods , Heart Valve Prosthesis Implantation/instrumentation , Heart Valve Prosthesis Implantation/adverse effects , Aged, 80 and over , Prospective Studies , Registries , Echocardiography, Transesophageal/methods , Follow-Up Studies , Heart Valve Prosthesis
15.
Am J Cardiol ; 228: 24-33, 2024 Aug 05.
Article in English | MEDLINE | ID: mdl-39097151

ABSTRACT

Transcatheter mitral edge-to-edge repair (TEER) with transcatheter devices has become a mainstay in the minimally invasive treatment of patients with severe mitral regurgitation at increased surgical risk. Despite its apparently favorable risk profile, there is uncertainty on the risk and features of cerebrovascular accidents (CVAs) early and long after transcatheter mitral valve repair. We aimed to appraise the incidence and predictors of CVA in patients who underwent TEER. We explicitly queried the data set of an ongoing multicenter prospective observational study dedicated to TEER with MitraClip (Abbott Vascular, Santa Clara, California). The incidence of CVAs after TEER was formally appraised, and we explored potential predictors of such events. Descriptive, bivariate, and diagnostic accuracy analyses were performed. Of 2,238 patients who underwent TEER, CVAs occurred in 33 patients (1.47% [95% confidence interval 1.02% to 2.06%]), including 6 (0.27% [0.10% to 0.58%]) in-hospital strokes and 27 events after discharge (0.99% [0.66% to 1.44%]), over a median follow-up of 14 months. Most CVAs were major ischemic strokes during and after the in-hospital phase. Overall, CVAs were more common in patients with atrial fibrillation (p = 0.018), renal dysfunction (p = 0.032), higher EuroSCORE II (p = 0.033), and, as expected, higher CHA2DS2-VASc score (p = 0.033), despite the limited prognostic accuracy of the score. Notably, the occurrence of CVA did not confer a significantly increased risk of long-term (p = 0.136) or cardiac death (p = 0.397). The incidence of CVA in patients who underwent TEER is low, with most events occurring after discharge and being associated with preexisting risk features. These findings, although reassuring on the safety of TEER, call for proactive antithrombotic therapy whenever CVA risk is increased before and after TEER.

16.
Clin Res Cardiol ; 113(1): 48-57, 2024 Jan.
Article in English | MEDLINE | ID: mdl-37138103

ABSTRACT

BACKGROUND: Transaxillary (TAx) transcatheter aortic valve implantation (TAVI) is a preferred alternative access in patients ineligible for transfemoral TAVI. AIMS: This study used the Trans-AXillary Intervention (TAXI) registry to compare procedural success according to different types of transcatheter heart valves (THV). METHODS: For the TAXI registry anonymized data of patients treated with TAx-TAVI were collected from 18 centers. Acute procedural, early and 1-month clinical outcomes were adjudicated in accordance with standardized VARC-3 definitions. RESULTS: From 432 patients, 368 patients (85.3%, SE group) received self-expanding (SE) THV and 64 patients (14.8%, BE group) received balloon-expandable (BE) THV. Imaging revealed lower axillary artery diameters in the SE group (max/min diameter in mm: 8.4/6.6 vs 9.4/6.8 mm; p < 0.001/p = 0.04) but a higher proportion of axillary tortuosity in BE group (62/368, 23.6% vs 26/64, 42.6%; p = 0.004) with steeper aorta-left ventricle (LV) inflow (55° vs 51°; p = 0.002) and left ventricular outflow tract (LVOT)-LV inflow angles (40.0° vs 24.5°; 0.002). TAx-TAVI was more often conducted by right sided axillary artery in the BE group (33/368, 9.0% vs 17/64, 26.6%; p < 0.001). Device success was higher in the SE group (317/368, 86.1% vs 44/64, 68.8%, p = 0.0015). In logistic regression analysis, BE THV were a risk factor for vascular complications and axillary stent implantation. CONCLUSIONS: Both, SE and BE THV can be safely used in TAx-TAVI. However, SE THV were more often used and were associated with a higher rate of device success. While SE THV were associated with lower rates of vascular complications, BE THV were more often used in cases with challenging anatomical circumstances.


Subject(s)
Aortic Valve Stenosis , Heart Valve Prosthesis , Transcatheter Aortic Valve Replacement , Humans , Transcatheter Aortic Valve Replacement/methods , Aortic Valve Stenosis/surgery , Treatment Outcome , Aortic Valve/surgery , Registries , Prosthesis Design
17.
J Am Heart Assoc ; 12(17): e029553, 2023 09 05.
Article in English | MEDLINE | ID: mdl-37646211

ABSTRACT

Background There is little evidence about the prognostic role of mitral regurgitation (MR) in patients with low-flow, low-gradient aortic stenosis undergoing transcatheter aortic valve replacement (TAVR). The aim of this study was to assess the prevalence and outcome implications of MR severity in patients with low-flow, low-gradient aortic stenosis undergoing TAVR, and to evaluate whether MR improvement after TAVR could influence clinical outcome. Methods and Results This study included consecutive patients with low-flow, low-gradient aortic stenosis undergoing TAVR at 2 Italian high-volume centers. The study population was categorized according to the baseline MR severity and to the presence of MR improvement at discharge. The primary outcome was the composite of all-cause death and hospitalization for worsening heart failure up to 1 year. The study included 268 patients; 57 (21%) patients showed MR >2+. Patients with MR >2+ showed a lower 1-year survival free from the primary outcome (P<0.001), all-cause death (P<0.001), and heart failure hospitalization (P<0.001) compared with patients with MR ≤2+. At multivariable analysis, baseline MR >2+ was an independent predictor of the primary outcome (P<0.001). Among patients with baseline MR >2+, MR improvement was reported in 24 (44%) cases after TAVR. The persistence of MR was associated with a significantly reduced survival free from the primary outcome, all-cause death, and heart failure hospitalization up to 1 year. Conclusions In this study, the presence of moderately severe to severe MR in patients with low-flow, low-gradient aortic stenosis undergoing TAVR portends a worse clinical outcome at 1 year. TAVR may improve MR severity in nearly half of the patients, resulting in a potential outcome benefit after discharge.


Subject(s)
Aortic Valve Stenosis , Heart Failure , Mitral Valve Insufficiency , Transcatheter Aortic Valve Replacement , Humans , Mitral Valve Insufficiency/epidemiology , Mitral Valve Insufficiency/surgery , Prognosis , Transcatheter Aortic Valve Replacement/adverse effects , Aortic Valve Stenosis/complications , Aortic Valve Stenosis/surgery , Heart Failure/epidemiology , Heart Failure/therapy
18.
Minerva Cardiol Angiol ; 71(3): 324-332, 2023 Jun.
Article in English | MEDLINE | ID: mdl-35332751

ABSTRACT

BACKGROUND: Transcatheter aortic valve implantation (TAVI) is emerging as an appealing management strategy for patients with severe aortic stenosis at intermediate, high or exceedingly high risk, but its risk-benefit profile in younger patients is less certain. We aimed to explore the outlook of patients aged 70 years or less and undergoing TAVI at 2 high-volume Italian institutions. METHODS: We retrospectively collected baseline, imaging, procedural and outcome features of patients with age ≤70 years in whom TAVI was attempted at participating centers between 2012 and 2021. Non-parametric tests and bootstrap resampling were used for inferential purposes. RESULTS: A total of 39 patients were included, out of >3000 screened with heart team involvement and >1500 receiving TAVI. Most common or relevant indications for TAVI reduced life expectancy (e.g. cardiogenic shock or severe left ventricular systolic dysfunction), chronic obstructive pulmonary disease, morbid obesity, active or recent extra-cardiac cancer, porcelain aorta, neurologic disability, cirrhosis, or prior surgical aortic valve replacement, as well as extreme cachexia, and Hutchinson-Gilford progeria. At least two contemporary high-risk features were present in most cases. Transapical access was used in 5 (12.8%) cases, and a sheathless approach in 15 (38.5%). A variety of devices were used, including both balloon- and self-expandable devices. Clinical outcomes were satisfactory, despite the high-risk profile, at both short- and mid-term, with no in-hospital death, and 5.1% (95% confidence interval 0-12.8%) mortality at a median follow-up of 15 months (minimum 1; maximum 85). Notably, no case of significant valve deterioration requiring reintervention occurred. CONCLUSIONS: In carefully selected patients with 70 years or less of age and prohibitive risk for surgery or reduced life expectancy, TAVI represents a safe option with a favorable mid-term survival and low rate of adverse events.


Subject(s)
Aortic Valve Stenosis , Transcatheter Aortic Valve Replacement , Humans , Transcatheter Aortic Valve Replacement/adverse effects , Transcatheter Aortic Valve Replacement/methods , Retrospective Studies , Aortic Valve Stenosis/surgery , Treatment Outcome , Aortic Valve/surgery
19.
Am J Cardiol ; 201: 349-358, 2023 08 15.
Article in English | MEDLINE | ID: mdl-37423004

ABSTRACT

Transcatheter aortic valve replacement (TAVR) is an established therapy for severe, symptomatic aortic valve stenosis even in patients with impaired left ventricular systolic function. However, there is uncertainty on the clinical effectiveness of the currently available TAVR devices in patients with reduced left ventricular ejection fraction (LVEF). The LOSTAVI (Low Systolic function and Transcatheter Aortic Valve Implantation) registry is a retrospective observational study using baseline, procedural, discharge, and long-term follow-up details. A total of 3 groups of interest were distinguished: extremely reduced LVEF (<25%), severely reduced LVEF (25% to 30%), and reduced LVEF (31% to 35%). Unadjusted and adjusted analyses were carried out for in-hospital and follow-up outcomes. A total of 923 patients were included from 12 centers, with 146 patients (16%) with LVEF <25%, 425 (46%) with LVEF 25% to 30%, and 352 (38%) with LVEF 31% to 35%. Several baseline and procedural features were different across groups, including age, risk, functional class, and prevalence of bicuspid disease (all p <0.05). In-hospital mortality was similar in the 3 groups (7 [4.8%], 18 [4.2%], and 7 [2.0%], respectively, p = 0.661), but major adverse events were more common in those with extremely reduced and severely reduced LVEF (19 [13%], 53 [13%], and 25 [7.1%], respectively, p = 0.024). The 12-month follow-up confirmed the significant detrimental impact of reduced LVEF on both death (21 [14%], 49 [12%], and 25 [7.1%], respectively, p = 0.024) and major adverse events (37 [25%], 89 [21%], and 53 [15%], respectively, p = 0.016). The adjusted analysis confirmed the significant prognostic role of LVEF on both outcomes, whereas TAVR device type was not associated with death or major adverse events (all p >0.05). In conclusion, TAVR yields favorable early and 1-year results in patients with reduced LVEF, including those with extremely depressed systolic dysfunction. However, reduced LVEF still represents a major adverse prognostic factor for both short- and mid-term outcomes.


Subject(s)
Aortic Valve Stenosis , Transcatheter Aortic Valve Replacement , Ventricular Dysfunction, Left , Humans , Ventricular Function, Left , Transcatheter Aortic Valve Replacement/methods , Stroke Volume , Treatment Outcome , Registries , Retrospective Studies , Aortic Valve/surgery
20.
Panminerva Med ; 65(4): 443-453, 2023 Dec.
Article in English | MEDLINE | ID: mdl-37259492

ABSTRACT

BACKGROUND: The clinical impact of coronary artery disease (CAD) on the prognosis of patients undergoing MitraClip implantation is still unclear. METHODS: One thousand nine hundred fifty-three patients undergoing MitraClip implantation included in the multicenter GIOTTO Registry were stratified according to CAD. Endpoints were all-cause death, cardiac death, and re-hospitalization for heart failure at follow-up (median 15.8 months). RESULTS: Although younger, CAD patients were more symptomatic, had worse cardiovascular risk profile, higher burden of comorbidities, more frequently affected by functional MR, with higher left ventricle (LV) diameters and lower ejection fraction (EF). At follow-up, CAD patients showed higher rates of all-cause death (25.4% vs. 19.6%; P=0.002), cardiovascular death (14.0% vs. 10.1%; P=0.007) and re-hospitalization for heart failure (13.9% vs. 10.2%; P=0.011). Dividing the population according to mitral regurgitation (MR) etiology (functional vs. non-functional MR), no differences were observed between CAD and no-CAD patients. At multivariate logistic regression, NYHA III/IV class, prior heart failure hospitalization, severe chronic kidney disease, atrial fibrillation, LV end-diastolic diameter and LVEF<30% but not CAD resulted independent predictors of all-cause death. The same finding was confirmed even after propensity score adjustment. CONCLUSIONS: CAD did not show a relevant impact on mid-term prognosis per se, but seemed to identify a more complex and diseased cohort of patients with worse clinical and functional status.


Subject(s)
Coronary Artery Disease , Heart Failure , Heart Valve Prosthesis Implantation , Mitral Valve Insufficiency , Humans , Coronary Artery Disease/complications , Coronary Artery Disease/surgery , Heart Failure/complications , Heart Valve Prosthesis Implantation/adverse effects , Heart Valve Prosthesis Implantation/methods , Mitral Valve/surgery , Mitral Valve Insufficiency/surgery , Mitral Valve Insufficiency/etiology , Treatment Outcome
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