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1.
Circ Cardiovasc Interv ; 16(12): e013232, 2023 12.
Article in English | MEDLINE | ID: mdl-37874646

ABSTRACT

BACKGROUND: Drug-coated balloons (DCB) are an emerging tool for modern percutaneous coronary intervention (PCI), but evidence on their use for de novo lesions on large vessels is limited. METHODS: Consecutive patients undergoing DCB-based PCI on the left anterior descending artery in 2 Italian centers from 2018 to 2022 were retrospectively enrolled and compared with patients who received left anterior descending PCI with contemporary drug-eluting stents (DES). In-stent restenosis was excluded. The DCB group included both patients undergoing DCB-only PCI and those receiving hybrid PCI with DCB and DES combined. The primary end point was target lesion failure at 2 years, defined as the composite of target lesion revascularization, cardiac death, and target vessel myocardial infarction. RESULTS: We included 147 consecutive patients undergoing DCB-based treatment on the left anterior descending artery and compared them to 701 patients who received conventional PCI with DES. In the DCB group, 43 patients (29.2%) were treated with DCB only and 104 (70.8%) with a hybrid approach; DCB length was greater than stent length in 55.1% of cases. Total treated length was higher in the DCB group (65 [40-82] versus 56 [46-66] mm; P=0.002), while longer DESs were implanted (38 [24-62] versus 56 [46-66] mm; P<0.001) and a higher rate of large vessels were treated (76.2% versus 83.5%; P=0.036) in the DES cohort. The cumulative 2-year target lesion failure incidence was not significantly different between the 2 groups (DCB, 4.1% versus DES, 9.8%; hazard ratio, 0.51 [95% CI, 0.20-1.27]; P=0.15). After a 1:1 propensity score matching resulting in 139 matched pairs, the DCB-based treatment was associated with a lower risk for target lesion failure at 2 years compared with DES-only PCI (hazard ratio, 0.2 [95% CI, 0.07-0.58]; P=0.003), mainly driven by less target lesion revascularization. CONCLUSIONS: A DCB-based treatment approach for left anterior descending revascularization allows a significantly reduced stent burden, thereby potentially limiting target lesion failure risk at midterm follow-up.


Subject(s)
Angioplasty, Balloon, Coronary , Coronary Artery Disease , Coronary Restenosis , Drug-Eluting Stents , Percutaneous Coronary Intervention , Humans , Percutaneous Coronary Intervention/adverse effects , Retrospective Studies , Drug-Eluting Stents/adverse effects , Treatment Outcome , Angioplasty, Balloon, Coronary/adverse effects , Angioplasty, Balloon, Coronary/methods , Coronary Vessels/diagnostic imaging , Coronary Artery Disease/diagnostic imaging , Coronary Artery Disease/therapy , Coronary Artery Disease/complications , Coated Materials, Biocompatible , Coronary Restenosis/diagnostic imaging , Coronary Restenosis/etiology , Coronary Restenosis/therapy
4.
JACC Cardiovasc Interv ; 11(15): 1482-1491, 2018 08 13.
Article in English | MEDLINE | ID: mdl-29803695

ABSTRACT

OBJECTIVES: The aims of the ERIS (Evolving Routine Standards of FFR Use) study are to describe the current use of invasive coronary physiology assessment and discern the reasons for its nonuse in daily practice. BACKGROUND: Adoption of coronary physiology guidance in the catheterization laboratory varies among countries, centers, and operators. METHODS: ERIS is an investigator-driven, nationwide, prospective, cross-sectional study involving 76 Italian catheterization laboratories. Each center had a 60-day window to include consecutive cases that fulfilled the inclusion and exclusion criteria. Two pre-specified groups were enrolled: 1) patients who had operators apply fractional flow reserve or instantaneous wave-free ratio assessment (physiology assessment group); and 2) patients who had operators decide not to perform fractional flow reserve or instantaneous wave-free ratio assessment, although the patients met the inclusion and exclusion criteria (visual estimation group). RESULTS: Overall, 1,858 cases were included (physiology assessment group, n = 1,177; visual estimation group, n = 681). Physiology-based guidance was used in 7% and 13% of the total volume of angiographic and percutaneous coronary interventions, respectively. Its use was in line with European and American guidelines in 48% of the cases (n = 569). Physiology guidance was used in a consistent number of patients with acute coronary syndromes (n = 529 [45%]). The main reason for not using physiology guidance was the operator's confidence that clinical and angiographic data alone were sufficient. CONCLUSIONS: Use of coronary physiology assessment in daily practice meets the current guideline indications in approximately 50% of cases. The major limiting factor for the adoption of physiology guidance was the operator's confidence in visual assessment alone. (Evolving Routine Standards of FFR Use [ERIS]; NCT03082989).


Subject(s)
Cardiac Catheterization/standards , Coronary Stenosis/diagnosis , Fractional Flow Reserve, Myocardial , Practice Patterns, Physicians'/standards , Aged , Clinical Competence/standards , Clinical Decision-Making , Coronary Angiography , Coronary Stenosis/physiopathology , Coronary Stenosis/therapy , Cross-Sectional Studies , Female , Health Care Surveys , Humans , Italy , Male , Middle Aged , Patient Selection , Percutaneous Coronary Intervention , Predictive Value of Tests , Prospective Studies , Reproducibility of Results , Severity of Illness Index , Treatment Outcome
5.
Int J Cardiol ; 257: 1-6, 2018 04 15.
Article in English | MEDLINE | ID: mdl-29506674

ABSTRACT

BACKGROUND: The potential protective effects of remote ischemic preconditioning (RIPC) on contrast-induced nephropathy (CIN) after percutaneous coronary intervention (PCI) remain to be defined. METHODS AND RESULTS: A double blind, randomized, placebo controlled multicenter study was performed. Patients younger than 85years old, with a renal clearance of 30-60ml/min/1.73m2, who were candidates for PCI for all clinical indications except for primary PCI, were allocated 1:1 to RIPC or to standard therapy. The primary endpoint was incidence of CIN. The secondary endpoint was incidence of peri-procedural myocardial infarction (PMI). From February 2013 to April 2014, 3108 patients who were scheduled for coronary angiography were screened for the study. 442 fulfilled the inclusion criteria and 223 received PCI. These patients were randomized to sham RIPC (n=107) or treatment group (n=116). The only pre-specified subgroup of diabetic patients included 85 (38%) cases. RIPC significantly reduced CIN incidence in the overall population (12.1% vs. 26.1%, p=0.01, with a NNT=9) and in non-diabetic patients (9.2% vs. 25.0%, p=0.02), but showed no benefit in diabetics (16.7% vs. 28.2%, p=0.21). A trend for lower PMI was seen in the intervention arm (creatine kinase - muscle brain >5 URL; 8.4% vs. 16.4%, p=0.07; troponin T >5 URL; 27% vs. 38%, p=0.21). CONCLUSIONS: Remote ischemic preconditioning significantly reduces the incidence of acute kidney injury in non-diabetic patients undergoing PCI. Larger sample size is presumably needed to assess the effect of RIPC for patients with diabetes mellitus. Clinical Trial number:NCT02195726https://www.clinicaltrial.gov/.


Subject(s)
Acute Kidney Injury/diagnostic imaging , Acute Kidney Injury/prevention & control , Contrast Media/adverse effects , Ischemic Preconditioning/trends , Percutaneous Coronary Intervention/trends , Acute Kidney Injury/chemically induced , Aged , Aged, 80 and over , China/epidemiology , Double-Blind Method , Europe/epidemiology , Female , Humans , Ischemic Preconditioning/methods , Ischemic Preconditioning, Myocardial/methods , Ischemic Preconditioning, Myocardial/trends , Male , Middle Aged , Prospective Studies
6.
J Cardiovasc Med (Hagerstown) ; 18(2): 103-108, 2017 Feb.
Article in English | MEDLINE | ID: mdl-27168140

ABSTRACT

BACKGROUND: Several factors have been identified as predictors of events after transcatheter aortic valve implantation (TAVI) but the impact of left ventricular ejection fraction (LVEF) and mean transaortic gradient (MTG) is controversial. This multicenter study aimed to clarify the prognostic role of low LVEF and low MTG after TAVI. METHODS: From 2007 to 2012, 764 consecutive patients with severe symptomatic aortic valve stenosis underwent TAVI at participating hospitals. Patients were divided according to LVEF and MTG into four groups. RESULTS: Sixty-four patients had LVEF 40% or less and MTG less than 40 mmHg, 76 had LVEF 40% or less and MTG at least 40 mmHg, 163 had LVEF more than 40% and MTG less than 40 mmHg, 461 had LVEF more than 40% and MTG at least 40 mmHg. Two-year mortality was significantly higher in patients with low LVEF and low MTG, whereas it was similar in patients with low LVEF and high MTG, high LVEF and low MTG, and high LVEF and high MTG (51.3 vs. 22.4 vs. 23.3. vs. 25.5%, respectively; P = 0.001). These results were confirmed by multivariate analysis, as the combination of low LVEF and low MTG (both less than 40) was identified as the stronger mid-term mortality predictor (hazard ratio 2.4, confidence interval 95% 1.4-3.9; P = 0.001). CONCLUSION: At least one parameter between LVEF or MTG over 40 predicts a good prognosis for TAVI patients at mid-term follow-up, whereas those with both left ventricular dysfunction and low mean aortic pressure gradient are at high risk of all-cause death after TAVI.


Subject(s)
Aortic Valve Stenosis/mortality , Aortic Valve Stenosis/surgery , Stroke Volume , Transcatheter Aortic Valve Replacement/adverse effects , Ventricular Dysfunction, Left/physiopathology , Aged , Aged, 80 and over , Aortic Valve/surgery , Echocardiography , Female , Follow-Up Studies , Humans , Italy , Kaplan-Meier Estimate , Male , Multivariate Analysis , Prognosis , Proportional Hazards Models , Prospective Studies , Severity of Illness Index , Treatment Outcome , Ventricular Function, Left
7.
EuroIntervention ; 12(12): 1448-1456, 2016 Dec 20.
Article in English | MEDLINE | ID: mdl-27998836

ABSTRACT

AIMS: The aim of this multicentre study was to investigate the in-hospital and midterm outcomes of rotational atherectomy (RA) followed by metallic stent implantation. METHODS AND RESULTS: Between 2002 and 2013, 1,176 de novo lesions with calcified coronary lesions treated by RA and metallic stent implantation at nine institutions were assessed. Patients with ST-segment elevation myocardial infarction (STEMI) within 30 days, cardiogenic shock before the procedure, lesions with thrombus, and in-stent restenosis were excluded from the current analysis. In-hospital major adverse cardiac events (MACE) occurred in 8.3% of cases, mainly driven by periprocedural myocardial infarction. The incidence of MACE was 16.0% at one-year and 24.9% at two-year follow-up, both driven by target vessel revascularisation (13.5% at one year and 19.8% at two years). Multivariable analysis revealed that dialysis was an independent predictor for both in-hospital MACE (OR 2.33, 95% CI: 1.11-4.87, p=0.03) and follow-up MACE (HR 4.14, 95% CI: 2.87-5.96, p<0.001), whilst drug-eluting stent (DES) use was associated with a reduction in follow-up MACE (HR 0.42, 95% CI: 0.26-0.67, p<0.001). CONCLUSIONS: RA appears to be safe and effective with acceptable in-hospital and follow-up MACE considering the severity of patient and lesion characteristics. DES implantation following RA was associated with a reduction in MACE during the follow-up period.


Subject(s)
Angioplasty, Balloon, Coronary , Atherectomy, Coronary , Coronary Artery Disease/therapy , Drug-Eluting Stents , Aged , Aged, 80 and over , Angioplasty, Balloon, Coronary/methods , Atherectomy, Coronary/adverse effects , Coronary Angiography/adverse effects , Drug-Eluting Stents/adverse effects , Female , Humans , Male , Middle Aged , Registries , Treatment Outcome
8.
EuroIntervention ; 12(12): 1457-1464, 2016 Dec 20.
Article in English | MEDLINE | ID: mdl-27998837

ABSTRACT

AIMS: The safety and efficacy of rotational atherectomy (RA) in patients presenting with non-ST-elevation myocardial infarction (NSTE-ACS) remain to be defined. The aim of our study was to assess the safety and efficacy of RA in NSTE-ACS patients with reference to both short- and long-term follow-up. METHODS AND RESULTS: This was an observational retrospective registry which enrolled all consecutive patients undergoing RA, comparing patients with stable angina (SA) and NSTE-ACS. In addition, ACS patients were matched with those not undergoing RA. The primary endpoint was angiographic success. Procedural complications and in-hospital MACE were secondary endpoints along with MACE during follow-up. One thousand three hundred and eight patients were included: 37% (484) with an NSTE-ACS diagnosis and 63% (824) in the SA group. Angiographic success did not differ between the groups (98.8% vs. 99.2%, p=0.57). By univariate analysis procedural complications were more frequent in the NSTE-ACS group (11.3% vs. 8.0%, p=0.04). In-hospital MACE rates were comparable (5.7% vs. 5.8%, p=0.93); by multivariate analysis NSTE-ACS patients showed a non-significant trend towards a higher risk of adverse events (HR 2.39, CI: 0.96-5.96, p=0.061). MACE after a median of 27.9 months was significantly higher in the NSTE-ACS group compared with the SA group (32.4% vs. 24.2%, log-rank p<0.001), results confirmed by multivariate analysis. After propensity score matching, NSTE-ACS patients undergoing RA had similar outcomes to ACS patients who did not undergo RA (16% vs. 13%, log-rank p=0.14). CONCLUSIONS: Rotational atherectomy has similar safety and angiographic outcome in patients with NSTE-ACS or SA. The higher rate of adverse cardiac events at follow-up in NSTE-ACS patients undergoing RA is comparable with a matched population of NSTE-ACS patients not undergoing RA.


Subject(s)
Acute Coronary Syndrome/diagnosis , Acute Coronary Syndrome/surgery , Atherectomy, Coronary , Aged , Aged, 80 and over , Atherectomy, Coronary/methods , Coronary Angiography/methods , Female , Humans , Male , Middle Aged , Propensity Score , Registries , Retrospective Studies , Treatment Outcome
9.
Catheter Cardiovasc Interv ; 88(6): E164-E172, 2016 Nov 15.
Article in English | MEDLINE | ID: mdl-27083771

ABSTRACT

BACKGROUND: Rotational atherectomy (RA) is relatively contraindicated in patients with lesions ≥25 mm of length. Aim of this study was to evaluate RA safety and efficacy in this subset of patients with new technology and devices. METHODS AND RESULTS: From April 2002 to August 2013, the ROTATE registry included all consecutive patients undergoing RA in 8 centres. They were divided into shorter lesion group (SLG, lesions < 25 mm) and longer lesion group (LLG, lesions ≥ 25 mm). The angiographic success (AS) was the primary end point. Procedural complications (PC), a composite end point of procedural perforation, slow flow/no flow, and in-hospital major acute cardiovascular events (MACE), were secondary end points, along with death, nonfatal MI, target lesion revascularization, and MACE during follow-up. Sensitivity analysis was performed according to generation of DES. 1186 patients were included: 51.5% in SLG and 48.4% in LLG. Mean age was 70.4 ± 9.3 years, 64.5% were male. AS and PC did not differ between the two groups (93% vs 91%, p = 0.24 and 9.8 vs 9.4%, p = 0.84). During follow-up (27.6 ± 22.9 months), MACE did not differ between the two groups (28% vs 29.1%, p = 0.95). At multivariate analysis chronic kidney disease, male gender increased risk of MACE (HR 1.94, IQR 1.29-2.0, p = 0.01, HR 0.52, IQR 0.34-0.79, p = 0.01) while second-generation DES seemed protective (HR 0.53, IQR 0.31-0.88, p = 0.02). Data were confirmed at sensitivity analysis for second-generation DES (759 pts, 63.9%). No differences were found in this subpopulation between the two groups in term of AS, PC, and long-term MACE (93.6% vs 93.5%, p = 0.28, 11.9% vs 9.4%, p = 0.32 and 25.5% vs 23.9%, p = 0.72, respectively). CONCLUSIONS: Treating coronary lesions ≥ 25 mm length with RA does not impact short- and long-term outcome, in particular, in patients with second-generation DES. © 2016 Wiley Periodicals, Inc.


Subject(s)
Atherectomy, Coronary/methods , Coronary Artery Disease/surgery , Percutaneous Coronary Intervention/methods , Registries , Aged , Coronary Angiography , Coronary Artery Disease/diagnosis , Female , Follow-Up Studies , Humans , Male , Retrospective Studies , Severity of Illness Index , Time Factors , Treatment Outcome
10.
Catheter Cardiovasc Interv ; 88(6): 881-889, 2016 Nov 15.
Article in English | MEDLINE | ID: mdl-26775275

ABSTRACT

OBJECTIVES: We aimed to investigate procedural feasibility and outcomes associated with planned rotational atherectomy (RA) for severely calcified coronary lesions. BACKGROUND: Limited data are available addressing the benefits of planned RA compared to provisional RA. METHODS: Between 2002 and 2013, all patients with calcified lesions treated by RA were enrolled. Of these, patients treated with planned RA (358 patients) were compared to those treated with provisional RA (309 patients). RESULTS: In-hospital major adverse cardiovascular events (MACE) were tended to be better in the planned RA group (unadjusted OR: 0.76; 95% CI: 0.44-1.31, P = 0.32, and adjusted OR: 0.59; 95% CI: 0.33-1.05, P = 0.07). The number of pre-dilation balloon catheters was significantly lower in the planned RA group (1.17 ± 0.60 vs. 1.47 ± 0.76, P < 0.001). Procedure time, fluoroscopy time, and contrast volume used were all significantly reduced in the planned RA group compared to the provisional RA group (procedure time; 65.2 ± 36.8min vs. 84.4 ± 43.1min, P < 0.001, fluoroscopy time; 33.1 ± 22.9min vs. 51.2 ± 29.6min, P < 0.001, and contrast volume; 232.9 ± 141.6ml vs. 302.9 ± 150.3ml, P < 0.001). The incidence of MACE at 1-year was significantly higher amongst the unadjusted population, whereas the difference was less marked between groups after propensity-score adjustment (unadjusted HR: 1.78; 95% CI: 1.16-2.74, P = 0.01, and adjusted HR: 1.44; 95% CI: 0.92-2.26, P = 0.11). CONCLUSIONS: Planned RA appears to be safe and was associated with a reduction in procedural and fluoroscopy times, contrast volume, and the number of pre-dilation balloon catheters used. If there is a strong likelihood of requiring RA for the treatment of severely calcified lesions, operators should have a low threshold for adopting a planned RA strategy. © 2016 Wiley Periodicals, Inc.


Subject(s)
Atherectomy, Coronary/methods , Coronary Artery Disease/surgery , Postoperative Complications/epidemiology , Registries , Vascular Calcification/surgery , Aged , Coronary Angiography , Coronary Artery Disease/diagnosis , Cross-Over Studies , Drug-Eluting Stents , Feasibility Studies , Female , Follow-Up Studies , Humans , Incidence , Italy/epidemiology , Male , Retrospective Studies , Survival Rate/trends , Time Factors , Vascular Calcification/diagnosis
11.
Am J Cardiol ; 116(4): 604-11, 2015 Aug 15.
Article in English | MEDLINE | ID: mdl-26081069

ABSTRACT

Although transcatheter aortic valve implantation (TAVI) is still currently guided by transesophageal echocardiography (TEE) in a considerable number of hospitals, exclusive angiographic (Angio) guidance seems a reasonable approach in this setting. To date, however, no studies have directly compared the outcomes of TAVI according to the imaging modality used for procedural guidance. We, therefore, used data from a large multicenter data repository to compare the outcomes of TAVI guided exclusively by Angio and ATEE. All consecutive patients with severe aortic stenosis who underwent TAVI with the CoreValve Revalving System (CRS) in 9 Italian centers from September 2007 to March 2014, dichotomized according to the imaging support used to guide the procedure (ATEE and Angio), were included. Thirty-day and 12-month clinical outcomes were evaluated. Propensity matching analysis was performed to adjust for baseline differences. A total of 625 patients were included (256 and 369 patients were included in the ATEE and Angio groups, respectively). Patients from the ATEE more frequently underwent TAVI under general anesthesia compared with Angio group (37.9% vs 22.8%, respectively, p <0.001). Importantly, ∼80% of the patients experienced mild or even less aortic regurgitation as assessed by angiography after the procedure, without between-group differences. Postdilation and valve-in-valve rates were equivalent (24.7% vs 25%, p = 0.934 and 5.5% vs 3.4%, respectively, p = 0.217). No differences were revealed in the rates of death, cardiovascular death, and stroke or transient ischemic attack at 12-month follow-up. These results were sustained after propensity matching analysis. In conclusion, as long as a comprehensive procedural planning is performed, TAVI with CRS may be performed exclusively under angiographic guidance without the need for associated TEE.


Subject(s)
Aortic Valve Stenosis/diagnosis , Aortic Valve Stenosis/surgery , Coronary Angiography , Echocardiography, Transesophageal , Surgery, Computer-Assisted , Transcatheter Aortic Valve Replacement , Aged , Aged, 80 and over , Aortic Valve Stenosis/mortality , Databases, Factual , Female , Follow-Up Studies , Humans , Male , Time Factors , Treatment Outcome
12.
Heart Lung Circ ; 24(9): 936-9, 2015 Sep.
Article in English | MEDLINE | ID: mdl-26048318

ABSTRACT

Regurgitation due to a paravalvular leak (PVL) is a complication that may affect patients undergoing surgical mechanical or bioprosthetic heart valve replacement. PVL can also occur after transcatheter aortic valve implantation (TAVI) in patients with severe aortic stenosis and is associated with significantly worse outcomes. We report a case in which different closure strategies and devices were attempted and required to percutaneously close a severe PVL after TAVI in a patient with prohibitive surgical risk.


Subject(s)
Aortic Valve Insufficiency , Cardiac Catheterization , Heart Valve Prosthesis Implantation , Aged, 80 and over , Aortic Valve Insufficiency/pathology , Aortic Valve Insufficiency/physiopathology , Aortic Valve Insufficiency/surgery , Female , Humans
13.
J Invasive Cardiol ; 27(2): 114-9, 2015 Feb.
Article in English | MEDLINE | ID: mdl-25661764

ABSTRACT

AIMS: Elevated values of systolic pulmonary artery pressure (sPAP) represent a common finding in patients with aortic stenosis and severe left ventricular hypertrophy. Prognostic impact of sPAP and its potential improvement after transcatheter aortic valve implantation (TAVI) remains to be determined. METHODS AND RESULTS: This is a multicenter retrospective registry in five European institutions. All consecutive patients undergoing TAVI were enrolled, and divided into two groups according to sPAP evaluated with echocardiography: ≤40 mm Hg and >40 mm Hg. All-cause mortality at follow-up of at least 1 year was the primary endpoint, while 30-day mortality, periprocedural complications, myocardial infarction, stroke, and reintervention rates at follow-up were the secondary endpoints. Among 674 patients enrolled, a total of 319 (47%) had sPAP >40 mm Hg. This was associated with higher mortality at 30 days (4.5% vs 8.5%; P=.03) and at a median follow-up of 477 days (17% vs 26%; P=.03). Improvement of sPAP was reported in 113 patients (27%), occurring more frequently in absence of moderate or severe mitral regurgitation and of right ventricle dysfunction. With multivariate adjustment, reduced renal function, insulin-dependent diabetes mellitus, and sPAP >40 mm Hg were independent predictors of all-cause mortality, improvement in sPAP values was related to a better survival, while ejection fraction was not. CONCLUSION: Elevated values of sPAP represent a common finding in patients undergoing TAVI. This parameter, along with its improvement, may be used to stratify risk and determine prognosis for patients undergoing TAVI.


Subject(s)
Aortic Valve Stenosis/surgery , Hypertension, Pulmonary/epidemiology , Pulmonary Artery/physiopathology , Pulmonary Wedge Pressure/physiology , Registries , Transcatheter Aortic Valve Replacement , Aged, 80 and over , Aortic Valve Stenosis/complications , Aortic Valve Stenosis/physiopathology , Echocardiography , Female , Humans , Hypertension, Pulmonary/diagnosis , Hypertension, Pulmonary/physiopathology , Incidence , Italy/epidemiology , Male , Netherlands/epidemiology , Prognosis , Retrospective Studies , Risk Factors , Severity of Illness Index , Treatment Outcome
14.
Heart Lung Circ ; 24(2): e19-22, 2015 Feb.
Article in English | MEDLINE | ID: mdl-25456504

ABSTRACT

In view of the high number of bioprosthetic valves implanted during the past 30 years, an increasing number of patients are coming to medical attention because of degenerated bioprostheses. Transcatheter aortic valve-in-valve implantation has been described as a less invasive alternative to re-operation to treat severe structural valve deterioration. As far as degenerated mitral valve bioprostheses are concerned, transcatheter transapical mitral valve-in-valve replacement (TMVR) has been less commonly performed, but may also become a viable alternative to re-do replacement surgery. We describe treatment of a degenerated bioprosthetic mitral valve, characterised by complete absence of any radio-opaque landmarks making the TMVR procedure very challenging.


Subject(s)
Bioprosthesis , Heart Valve Prosthesis Implantation/methods , Heart Valve Prosthesis , Mitral Valve/surgery , Prosthesis Failure , Aged, 80 and over , Female , Humans
15.
Am J Cardiol ; 114(12): 1867-74, 2014 Dec 15.
Article in English | MEDLINE | ID: mdl-25438915

ABSTRACT

Surgical risk scores fail to accurately predict mortality after transcatheter aortic valve implantation (TAVI). The aim of this study was to develop and validate a dedicated risk score for accurate estimation of mortality risk in these patients. All consecutive patients who underwent TAVI at 6 international institutions were enrolled. Predictors for 1-year all-cause mortality were identified by means of Cox multivariate analysis and incorporated in a prediction score. Accuracy of the score was derived and externally validated for 30-day and 1-year mortality. The net classification improvement compared with the Society of Thoracic Surgeons (STS) score was appraised. A total of 1,064 patients constituted the derivation cohort and 180 patients constituted the external validation cohort. A total of 165 patients (15%) died at 1-year follow-up. Previous stroke (odds ratio [OR] 1.80, 1.4 to 3), inverse of renal clearance (OR 8, 6 to 14), and systolic pulmonary arterial pressure ≥50 mm Hg (OR 2.10, 1.5 to 3) were independently related to 1-year mortality. Area under the curve (AUC) of the survival post TAVI (STT) for 1-year mortality was 0.68 (0.62 to 0.71). At 30 days, 65 patients (7%) had died and the AUC for the STT at this time point was 0.66 (0.64 to 0.75). In the external validation cohorts, the AUC of the STT were 0.66 (0.56 to 0.7) for 30-day and 0.67 (0.62 to 0.71) for 1-year mortality. Net reclassification improvement for STT compared with STS was 31% (p <0.001) for 30-day mortality and 14% (p <0.001) for 1-year mortality. In conclusion, the STT score represents an easy and accurate tool to assess the risk of short-term and mid-term mortality in patients undergoing TAVI.


Subject(s)
Aortic Valve Stenosis/surgery , Postoperative Complications/epidemiology , Risk Assessment/methods , Transcatheter Aortic Valve Replacement/adverse effects , Aged, 80 and over , Aortic Valve Stenosis/mortality , Female , Follow-Up Studies , Humans , Incidence , Italy/epidemiology , Male , Odds Ratio , Reproducibility of Results , Retrospective Studies , Risk Factors , Survival Rate/trends , Time Factors , Treatment Outcome
16.
EuroIntervention ; 10(6): 739-45, 2014 Oct.
Article in English | MEDLINE | ID: mdl-25330506

ABSTRACT

AIMS: We sought to evaluate the outcome of transcatheter aortic valve replacement (TAVR) with the CoreValve Revalving System (CRS-TAVR) in inoperable patients presenting with severe aortic regurgitation (AR), compared to in patients treated for severe native aortic stenosis (AS). From October 2008 to January 2013, 1,557 consecutive patients undergoing CRS-TAVR, of whom 26 (1.6%) presented with AR, were prospectively followed. Compared with patients with AS, patients with AR were significantly younger (mean age 73±10 vs. 82±6, p=0.02), more frequently in NYHA Class III/IV (95% vs. 73%, p=0.01) and had a higher incidence of severe pulmonary hypertension (sPAP >60 mmHg, 31% vs. 10%, p=0.007). Log EuroSCORE and STS score were similar. VARC-2-defined device success was lower in the AR group (79% vs. 96%, p=0.006). At one month, patients treated for AR had a higher overall mortality (23% vs. 5.9%; OR 4.22 [3.03-8.28], p<0.001) and cardiac mortality (15.3% vs. 4%, OR 4.01 [2.40-7.66], p<0.001). Results were consistent at 12 months: overall mortality (31% vs. 19%, HR 2.1 [1.5-4.41], p<0.001) and cardiac mortality (19.2% vs. 6%, HR 3.1 [2.09-8.22], p<0.001). CRS-TAVR for AR is associated with a significantly higher mortality compared to CRS-TAVR for AS. Considering the ominous prognosis of these patients when treated medically, TAVR may be a reasonable choice in selected patients. In this regard, conventional risk scores have an inadequate predictive value.


Subject(s)
Aortic Valve Insufficiency/surgery , Aortic Valve Stenosis/surgery , Aortic Valve/surgery , Heart Valve Prosthesis Implantation/mortality , Heart Valve Prosthesis , Age Distribution , Aged , Aged, 80 and over , Aortic Valve Insufficiency/mortality , Aortic Valve Stenosis/mortality , Bundle-Branch Block/epidemiology , Heart Valve Prosthesis Implantation/methods , Humans , Hypertension, Pulmonary/epidemiology , Italy/epidemiology , Registries , Severity of Illness Index
17.
Am J Cardiol ; 114(8): 1269-74, 2014 Oct 15.
Article in English | MEDLINE | ID: mdl-25159239

ABSTRACT

The impact of gender-related pathophysiologic features of severe aortic stenosis on transcatheter aortic valve implantation (TAVI) outcomes remains to be determined, as does the consistency of predictors of mortality between the genders. All consecutive patients who underwent TAVI at 6 institutions were enrolled in this study and stratified according to gender. Midterm all-cause mortality was the primary end point, with events at 30 days and at midterm as secondary end points. All events were adjudicated according to Valve Academic Research Consortium definitions. Eight hundred thirty-six patients were enrolled, 464 (55.5%) of whom were female. At midterm follow-up (median 365 days, interquartile range 100 to 516) women had similar rates of all-cause mortality compared with men (18.1% vs 22.6%, p = 0.11) and similar incidence of myocardial infarction and cerebrovascular accident. Gender did not affect mortality also on multivariate analysis. Among clinical and procedural features, glomerular filtration rate <30 ml/min/1.73 m(2) (hazard ratio [HR] 2.55, 95% confidence interval [CI] 1.36 to 4.79) and systolic pulmonary arterial pressure >50 mm Hg (HR 2.26, 95% CI 1.26 to 4.02) independently predicted mortality in women, while insulin-treated diabetes (HR 3.45, 95% CI 1.47 to 8.09), previous stroke (HR 3.42, 95% CI 1.43 to 8.18), and an ejection fraction <30% (HR 3.82, 95% CI 1.41 to 10.37) were related to mortality in men. Postprocedural aortic regurgitation was independently related to midterm mortality in the 2 groups (HR 11.19, 95% CI 3.3 to 37.9). In conclusion, women and men had the same life expectancy after TAVI, but different predictors of adverse events stratified by gender were demonstrated. These findings underline the importance of a gender-tailored clinical risk assessment in TAVI patients.


Subject(s)
Aortic Valve Stenosis/surgery , Cardiac Catheterization , Heart Valve Prosthesis Implantation/methods , Postoperative Complications/epidemiology , Risk Assessment/methods , Aortic Valve Stenosis/mortality , Cause of Death/trends , Female , Follow-Up Studies , Humans , Incidence , Italy/epidemiology , Male , Netherlands/epidemiology , Prognosis , Retrospective Studies , Sex Distribution , Sex Factors , Survival Rate/trends , Time Factors
18.
Heart Lung Circ ; 22(5): 383-5, 2013 May.
Article in English | MEDLINE | ID: mdl-23164807

ABSTRACT

Severe aortic regurgitation (AR), when intervention is required, is managed by surgical aortic valve replacement (SAVR). Recently, transcatheter aortic valve replacement (TAVR) for severe aortic stenosis (AS) has shown non-inferiority to SAVR and superiority to medical management. TAVR could be a valid "off label" option to treat severe AR for patients unsuitable for SAVR due to their high surgical risk. Among aortic pathologies leading to severe AR, those involving the aortic root are considered as high risk procedures and thus prohibit TAVR. For these reasons TAVR is not an option for severe AR due to concomitant aortic root dilatation and degeneration. We report a successful case of TAVR for severe AR due to dilatation of degenerated tract of aortic root.


Subject(s)
Aorta , Aortic Valve Insufficiency/surgery , Aortic Valve/surgery , Blood Vessel Prosthesis , Heart Valve Prosthesis Implantation , Heart Valve Prosthesis , Aged, 80 and over , Female , Humans
19.
Circ J ; 76(8): 1874-9, 2012.
Article in English | MEDLINE | ID: mdl-22665071

ABSTRACT

BACKGROUND: Stent thrombosis (ST) is a multi-factorial process involving different mechanisms. The impact of inherited coagulation disorders in the genesis of ST has never been assessed. The aim of the present study was to evaluate the prevalence of G1691A Factor V Leiden mutation, G20210A Factor II (prothrombin) mutation and C677T homozygous methylenetetrahydrofolate reductase (MTHFR) polymorphism in patients with ST. METHODS AND RESULTS: The prevalence of the aforementioned gene variations was assessed in 127 patients: 50 admitted for ST and 77 previously treated with percutaneous coronary intervention not developing ST. A control cohort of 529 healthy volunteers was sampled from the same geographical area. Patients with ST were carriers of at least 1 gene variation in 28% of cases. The prevalence of G1691A Factor V Leiden mutation (odds ratio [OR]=0.64; 95% confidence interval [CI]: 0.04-10.5), G20210A Factor II mutation (OR=0.63; 95% CI: 0.12-3.28) and C677T MTHFR homozygous polymorphism (OR=1.13; 95% CI: 0.47-2.72) did not differ significantly among patients with or without ST. The logistic regression model did not show a significant association between gene variations and ST (OR=0.61; 95% CI: 0.24-1.60; P=0.32). CONCLUSIONS: A specific association between studied gene variations and ST has not been detected. The relatively high prevalence of at least 1 gene anomaly in such a rare subset of patients, and its consequences in term of secondary prevention therapy, suggests that screening for thrombophilia might be justifiable in cases of ST.


Subject(s)
Factor V/genetics , Methylenetetrahydrofolate Reductase (NADPH2)/genetics , Mutation, Missense , Polymorphism, Genetic , Prothrombin/genetics , Stents/adverse effects , Thrombophilia , Thrombosis , Aged , Amino Acid Substitution , Female , Humans , Male , Middle Aged , Prevalence , Thrombophilia/epidemiology , Thrombophilia/genetics , Thrombosis/epidemiology , Thrombosis/etiology , Thrombosis/genetics
20.
PLoS One ; 7(12): e53030, 2012.
Article in English | MEDLINE | ID: mdl-23285251

ABSTRACT

PTX3 is a long pentraxin of the innate immune system produced by different cell types (mononuclear phagocytes, dendritic cells, fibroblasts and endothelial cells) at the inflammatory site. It appears to have a cardiovascular protective function by acting on the immune-inflammatory balance in the cardiovascular system. PTX3 plasma concentration is an independent predictor of mortality in patients with acute myocardial infarction (AMI) but the influence of PTX3 genetic variants on PTX3 plasma concentration has been investigated very little and there is no information on the association between PTX3 variations and AMI. Subjects of European origin (3245, 1751 AMI survivors and 1494 controls) were genotyped for three common PTX3 polymorphisms (SNPs) (rs2305619, rs3816527, rs1840680). Genotype and allele frequencies of the three SNPs and the haplotype frequencies were compared for the two groups. None of the genotypes, alleles or haplotypes were significantly associated with the risk of AMI. However, analysis adjusted for age and sex indicated that the three PTX3 SNPs and the corresponding haplotypes were significantly associated with different PTX3 plasma levels. There was also a significant association between PTX3 plasma concentrations and the risk of all-cause mortality at three years in AMI patients (OR 1.10, 95% CI: 1.01-1.20, p = 0.02). Our study showed that PTX3 plasma levels are influenced by three PTX3 polymorphisms. Genetically determined high PTX3 levels do not influence the risk of AMI, suggesting that the PTX3 concentration itself is unlikely to be even a modest causal factor for AMI. Analysis also confirmed that PTX3 is a prognostic marker after AMI.


Subject(s)
C-Reactive Protein/analysis , C-Reactive Protein/genetics , Myocardial Infarction/blood , Myocardial Infarction/genetics , Serum Amyloid P-Component/analysis , Serum Amyloid P-Component/genetics , Aged , Biomarkers/analysis , Biomarkers/blood , Biomarkers/metabolism , Blood Chemical Analysis , Case-Control Studies , Female , Gene Frequency , Genetic Predisposition to Disease , Humans , Male , Middle Aged , Myocardial Infarction/diagnosis , Osmolar Concentration , Polymorphism, Single Nucleotide , Prognosis , Risk Factors
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