Chiara Fraccaro - Academia.edu (original) (raw)

Papers by Chiara Fraccaro

Research paper thumbnail of Using wearable devices to monitor physical activity in patients undergoing aortic valve replacement: the CAPABILITY study protocol (Preprint)

BACKGROUND In the last decades, several tools have been developed to measure physical function ob... more BACKGROUND In the last decades, several tools have been developed to measure physical function objectively; however, their use has not been well established in clinical practice. OBJECTIVE The present study aims to describe the preoperative physical function and to assess and compare 6-month postoperative changes in the physical function of patients undergoing AS treatment with either surgical aortic valve replacement (SAVR) or transcatheter aortic valve replacement (TAVR) and to evaluate the feasibility of wearable devices in assessing physical function in such patients. METHODS Prospective observational study. The enrolment will be performed 1-month before TAVR/SAVR. Patients will be provided with the wearable device at baseline (activity tracker vívoactive® 3 devices by Garmin©). They will be trained in the use of the device, and they will be requested to wear it on the wrist of their preferred hand until 12-month after TAVR/SAVR. After baseline assessment, they will undergo four...

Research paper thumbnail of TCT-635 Unmasking Myocardial Bridge Related Ischemia by Intracoronary Functional Evaluation

Journal of the American College of Cardiology, 2018

eight patients (mean age 62AE13 years, 55% female, 39% ST-segment elevation) were included. Media... more eight patients (mean age 62AE13 years, 55% female, 39% ST-segment elevation) were included. Median worst diameter stenosis was 35% by angiography, and 5 patients (13%) had normal angiograms. Plaque disruption and coronary thrombus were observed in 9 patients (24%) and 7 patients (18%), respectively. Ischemic-type late gadolinium-enhancement was present in 7 of 31 patients (23%) undergoing CMR, and was more common in patients with versus without plaque disruption (50% vs. 13%, p¼0.053) and coronary thrombus (67% vs. 12%, p¼0.014). Whereas IRA showed significantly more plaque rupture, thrombus, eroded plaque, and thin-cap fibroatheroma, as well as less calcified plaque than the non-IRA, there were no differences in minimum lumen area and percentage stenosis on OCT. The immediate interpretation of the OCT resulted in modification of the initial treatment strategy in 6 of 38 patients (16%).

Research paper thumbnail of IFT09. Clinical Impact of Significant Carotid Stenosis in Patients Undergoing Transcatheter Aortic Valve Implantation

Journal of Vascular Surgery, 2019

Research paper thumbnail of 1-Year Clinical Outcomes in Women After Transcatheter Aortic Valve Replacement: Results From the First WIN-TAVI Registry

JACC. Cardiovascular interventions, Jan 8, 2018

This study sought to examine the safety and performance of contemporary transcatheter aortic valv... more This study sought to examine the safety and performance of contemporary transcatheter aortic valve replacement (TAVR) in an exclusive all-women TAVR population, and to further investigate the potential impact of female sex-specific characteristics on composite 1-year clinical outcomes. Women comprise ≥50% patients undergoing TAVR. Several data have shown the noninferiority of TAVR compared with surgical aortic valve replacement for symptomatic significant aortic stenosis, but no study so far has been specifically powered to detect differences by sex. The WIN-TAVI (Women's INternational Transcatheter Aortic Valve Implantation) registry is a multinational, prospective, observational registry of women undergoing TAVR for significant aortic stenosis, across 18 sites in Europe and 1 site in the United States, between January 2013 and December 2015. The primary Valve Academic Research Consortium (VARC)-2 efficacy endpoint was a composite of mortality, stroke, myocardial infarction, ho...

Research paper thumbnail of Long-term outcomes and prosthesis performance after transcatheter aortic valve replacement: results of self-expandable and balloon-expandable transcatheter heart valves

Annals of cardiothoracic surgery, 2017

Data on transcatheter aortic valve replacement (TAVR) long-term clinical outcomes and hemodynamic... more Data on transcatheter aortic valve replacement (TAVR) long-term clinical outcomes and hemodynamic performance of the self-expandable CoreValve (CV) and the balloon-expandable Edwards SAPIEN XT (ES) (Edwards Lifesciences, Irvine, California, USA) transcatheter heart valves (THV) are limited. Therefore, this study aimed to compare long-term clinical outcome data and hemodynamic performance of TAVR with either CV or ES. We reviewed prospectively collected data of 171 patients treated with TAVR for severe aortic stenosis (AS) at our center between June 2007 and December 2010, with last follow-up contact in 2016. Out of 171 patients treated with TAVR at our Institution, 87 received a CV and 84 an ES THV. Mean age was 81 [78-85] years, and mean Society of Thoracic Surgeons (STS) score was 7.5% (4.5-13.9%). Hemodynamic success by Valve Academic Research Consortium (VARC) definition was 97.1%. Mean trans-prosthetic gradient remained low and stable during follow-up in both groups (at 5-year ...

Research paper thumbnail of Transcatheter aortic valve implantation at institutions without cardiovascular surgery departments: many questions still linger before a paradigm shift

Journal of thoracic disease, 2016

Research paper thumbnail of Survival After Varying Revascularization Strategies in Patients With ST-Segment Elevation Myocardial Infarction and Multivessel Coronary Artery Disease

JACC: Cardiovascular Interventions, 2016

OBJECTIVES The authors conducted a systematic pairwise and network meta-analysis to assess optima... more OBJECTIVES The authors conducted a systematic pairwise and network meta-analysis to assess optimal treatment strategies in patients with ST-segment elevation myocardial infarction (STEMI) and multivessel coronary artery disease (MV-CAD) undergoing primary percutaneous coronary intervention (PCI). BACKGROUND Patients with STEMI and MV-CAD have a worse prognosis than those with single-vessel CAD. The optimal revascularization strategy for these patients is uncertain. METHODS Studies of revascularization strategies for MV-CAD in STEMI patients undergoing primary PCI published between 2001 and 2015 were identified using an electronic search. Pairwise and network meta-analyses were performed for 3 PCI strategies in prospective and retrospective studies: 1) infarct-related artery (IRA)-only PCI; 2) single procedure MV-PCI; and 3) staged MV-PCI. Information on study design, inclusion and exclusion criteria, and clinical outcomes was extracted. The outcomes of interest were short-term and long-term mortality. RESULTS Thirty-two studies (13 prospective and 19 retrospective) with 54,148 patients (IRA-only PCI [n ¼ 42,112], single procedure MV-PCI [n ¼ 8,138], and staged MV-PCI [n ¼ 3,898]) were included in the analysis. Pairwise metaanalyses showed that staged MV-PCI was associated with lower short-term and long-term mortality compared with both IRA-only PCI and single stage MV-PCI, whereas IRA-only PCI was associated with lower mortality compared with single stage MV-PCI. Staged MV-PCI was also associated consistently with improved survival in network analyses. CONCLUSIONS The present systematic review and meta-analysis supports the hypothesis that in patients with MV-CAD presenting with STEMI undergoing primary PCI, a staged multivessel revascularization strategy may improve early and late survival.

Research paper thumbnail of Acute and 30-Day Outcomes in Women After TAVR: Results From the WIN-TAVI (Women's INternational Transcatheter Aortic Valve Implantation) Real-World Registry

JACC. Cardiovascular interventions, Aug 8, 2016

The study sought to examine the safety and performance of transcatheter aortic valve replacement ... more The study sought to examine the safety and performance of transcatheter aortic valve replacement (TAVR) using an all-female registry and to further explore the potential impact of female sex-specific characteristics on clinical outcomes after TAVR. Although women comprise 50% of patients with symptomatic severe aortic stenosis undergoing TAVR, the optimal treatment strategy remains undetermined. The WIN-TAVI (Women's INternational Transcatheter Aortic Valve Implantation) registry is a multinational, prospective, observational registry of women undergoing TAVR for aortic stenosis, conducted without any external funding. The primary endpoint was the Valve Academic Research Consortium (VARC)-2 early safety endpoint at 30 days (composite of mortality, stroke, major vascular complication, life-threatening bleeding, stage 2 or 3 acute kidney injury, coronary artery obstruction, or repeat procedure for valve-related dysfunction). Between January 2013 and December 2015, 1,019 women were...

Research paper thumbnail of Early and Midterm Outcome of Propensity-Matched Intermediate-Risk Patients Aged ≥80 Years With Aortic Stenosis Undergoing Surgical or Transcatheter Aortic Valve Replacement (from the Italian Multicenter OBSERVANT Study)

The American Journal of Cardiology, 2016

Research paper thumbnail of Optimal duration of dual antiplatelet therapy after second-generation drug-eluting stent implantation in patients with diabetes: The SECURITY (Second-Generation Drug-Eluting Stent Implantation Followed By Six- Versus Twelve-Month Dual Antiplatelet Therapy)-diabetes substudy

International Journal of Cardiology, 2016

Optimal duration of dual antiplatelet therapy after secondgeneration drug-eluting stent implantat... more Optimal duration of dual antiplatelet therapy after secondgeneration drug-eluting stent implantation in patients with diabetes: The SECURITY (Second-Generation Drug-Eluting Stent Implantation Followed By Six-Versus Twelve-Month Dual Antiplatelet Therapy)-diabetes substudy,

Research paper thumbnail of Intermediate Clinical and Hemodynamic Outcomes After Transcatheter Aortic Valve Implantation

The Annals of Thoracic Surgery, 2016

Background. Concerns still exist regarding long-term results and freedom from valve-related adver... more Background. Concerns still exist regarding long-term results and freedom from valve-related adverse events in transcatheter aortic valve implantation (TAVI). The aim of this single-center retrospective study was to assess intermediate-term (up to 5-year) clinical and hemodynamic outcomes in patients undergoing TAVI. Methods. From 2007 through 2013, 338 consecutive patients underwent TAVI at our institution. Preoperative variables were defined according to the European System for Cardiac Operative Risk Evaluation (EuroSCORE) definitions, and outcomes were reported according to the Valve Academic Research Consortium (VARC)-2 definitions. Multivariate logistic regression analysis was performed to identify independent predictors of mortality at follow-up. Results. transfemoral (TF) and transapical (TA) TAVI were performed in 233 (69%) and 105 (31%) patients, respectively. All-cause 30-day mortality was 4.4%, with no differences between TA and TF procedures. Thirtyday cardiovascular death, stroke, and myocardial infarction were not different between groups. The acute kidney

Research paper thumbnail of Development and Validation of a Distal Embolization Risk Score During Primary Angioplasty in ST-Elevation Myocardial Infarction

The American Journal of Cardiology, 2015

This study aims to develop and validate a new angiographic risk score to predict the risk of dist... more This study aims to develop and validate a new angiographic risk score to predict the risk of distal embolization (DE) during primary percutaneous coronary intervention (p-PCI) for ST-elevation myocardial infarction. Study included data from 1,200 patients who underwent p-PCI. The cohort was randomly split into a derivation cohort (n = 814) and a validation cohort (n = 386). Logistic regression was used to examine the relation between risk factors and the occurrence of DE. To each covariate in the model was assigned an integer score based on the regression coefficients. Variables included in the risk score, according to multivariable analysis, were occlusion pattern of infarct-related artery, Thrombolysis In Myocardial Infarction Thrombus Score 2 to 4, reference vessel diameter ≥3.5 mm, and lesion length >20 mm. To each variable was assigned a 0- to +2-point score according to the strength of the statistical association. Rates of DE in low-, intermediate-, and high-risk groups were 5.6%, 15.8%, and 40% in the derivation cohort (p for trend <0.0001; C-statistic 0.70) and 7.5%, 12.1%, and 37.9% in the validation cohort (p for trend <0.0001; C-statistic 0.62), respectively. In conclusion, the individual risk of DE in patients who underwent p-PCI can be predicted using a simple 4-variables model based on angiographic features.

Research paper thumbnail of Long-term results of the amplatzer cribriform occluder for patent foramen ovale with associated atrial septal aneurysm: impact on occlusion rate and left atrial functional remodelling

American journal of cardiovascular disease, 2012

Treatment of patients with concomitant patent foramen ovale (PFO) and atrial septal aneurysm (ASA... more Treatment of patients with concomitant patent foramen ovale (PFO) and atrial septal aneurysm (ASA) poses a number of challenges; while some authors have suggested the off-label use of the Amplatzer Cribriform Occluder in such anatomy, the long-term outcomes of this strategy is unknown. Our study aimed to assess the long-term impact on closure rate, left atrial functional remodelling, and clinical outcomes of off-label implantation of Amplatzer ASD Cribriform Occluder in patients with PFO and ASA. We prospectively enrolled 160 consecutive patients with previous stroke (mean age 36 ± 9.5 years, 109 females), significant PFO and ASA. All patients were treated with Amplatzer Cribriform Occluder to ensure the most complete possible coverage of the ASA. Residual shunt and LA passive and active emptying, LA conduit function, and LA ejection fraction were computed before and after 6 months from the procedure and then yearly. All patients underwent successful transcatheter closure (mean rati...

Research paper thumbnail of Prospective analysis of 30-day safety and performance of transfemoral transcatheter aortic valve implantation with Edwards SAPIEN XT versus SAPIEN prostheses

Archives of Cardiovascular Diseases, 2012

Background.-A new generation of balloon-expandable valves (e.g. Edwards SAPIEN XT) enables the us... more Background.-A new generation of balloon-expandable valves (e.g. Edwards SAPIEN XT) enables the use of a decreased sheath size using the NovaFlex TM delivery system for transfemoral transcatheter aortic valve implantation (TAVI). However, there are few data analysing the efficacy and safety of this new prosthesis.

Research paper thumbnail of Comparison of Balloon-Expandable Versus Self-Expandable Valves for Transcatheter Aortic Valve Implantation in Patients With Low-Gradient Severe Aortic Stenosis and Preserved Left Ventricular Ejection Fraction

The American Journal of Cardiology, 2015

A relevant proportion of patients, classified as severe aortic stenosis on the basis of valve are... more A relevant proportion of patients, classified as severe aortic stenosis on the basis of valve area £1 cm 2 , have a mean transvalvular gradient £40 mm Hg, despite a preserved left ventricular ejection fraction (LGSAS). We assessed the clinical and hemodynamic impact of transcatheter aortic valve implantation in patients with symptomatic LGSAS at high risk for surgery or inoperable, according to the type of percutaneous valve implanted. Ninetyfive patients received an Edwards SAPIEN valve (Edwards Lifesciences, Irvine, California) and 51 received a Medtronic CoreValve (Medtronic, Inc., Minneapolis, Minnesota). The hemodynamic performance of the 2 valves was similar in term of final transvalvular gradients (10 mm Hg, p [ 0.069). Early mortality rate was 7% and was not different between the 2 valves (p [ 0.73). During follow-up, cardiovascular mortality rate was similar between groups, and valve type was not a predictor of outcome (p [ 0.72). Estimated survival by KaplaneMeier at 2 years was 70%. At multivariate analysis, lifethreatening or major bleeding, postprocedural aortic insufficiency, and acute kidney injury were the major predictors of an adverse outcome. In patients with LGSAS treated by transcatheter aortic valve implantation, the use of balloon-expandable versus selfexpandable valves resulted in similar hemodynamic, early, and long-term clinical outcomes.

Research paper thumbnail of Acute Coronary Syndrome With Clear Coronary Artery

JACC: Cardiovascular Interventions, 2010

A 67-year-old obese woman with a history of hypertension and dyslipidemia was admitted at our ins... more A 67-year-old obese woman with a history of hypertension and dyslipidemia was admitted at our institution because of non-ST-segment elevation myocardial infarction. Electrocardiography at admission showed flat T waves in inferiorlateral leads. Two-dimensional transthoracic echocardi-ography revealed infero-lateral wall hypokinesia. Troponin I peaked at 18 g/l. Coronary angiography showed patent coronary arteries without significant stenoses and with Thrombolysis In Myocardial Infarction (TIMI) flow grade 3. Indeed, an intermediate tubular lesion with smooth

Research paper thumbnail of Expanding the Eligibility for Transcatheter Aortic Valve Implantation

JACC: Cardiovascular Interventions, 2009

Objectives Our aim was to assess the safety and feasibility of the retrograde trans-subclavian ap... more Objectives Our aim was to assess the safety and feasibility of the retrograde trans-subclavian approach to transcatheter aortic valve implantation (TAVI) in selected high-risk patients with aortic stenosis (AS) and severe peripheral vasculopathy. Background TAVI is an emerging therapeutic option to treat inoperable/high-risk patients affected by symptomatic AS. However, these patients are also often affected by severe iliac-femoral arteriopathy, rendering the transfemoral approach unemployable for percutaneous revalving procedure. Methods From among those patients in our department between May 2007 and December 2008, who were refused surgical aortic valve replacement because of high surgical risk and were ineligible for transfemoral percutaneous aortic valve replacement, we scheduled 3 for TAVI by the subclavian approach. Procedures were performed by a combined team of cardiologists, cardiac surgeons, and anesthetists in the catheterization laboratory. The III generation CoreValve Revalving System (Core-Valve Inc., Irvine, California) with an 18-F delivery system was introduced in all cases by the left subclavian artery. Results Prosthetic valves were successfully implanted in all 3 cases, leading to a fall in transvalvular gradient without significant paravalvular regurgitation. No intraprocedural or periprocedural complications occurred. Two patients developed an atrioventricular block requiring the implantation of a permanent pacemaker. All patients were discharged in asymptomatic status, with good prosthesis performance. No adverse events occurred within the 3-month follow-up. Conclusions TAVI by subclavian retrograde approach seems safe and feasible in inoperable/high-risk patients with AS and peripheral vasculopathy, who are neither eligible for surgical valve replacement nor transfemoral percutaneous aortic valve implantation. Further studies are needed to evaluate the longterm efficacy of this new therapy.

Research paper thumbnail of Time-Dependent Detrimental Effects of Distal Embolization on Myocardium and Microvasculature During Primary Percutaneous Coronary Intervention

JACC: Cardiovascular Interventions, 2012

Objectives The authors sought to investigate the impact of distal embolization (DE) on myocardial... more Objectives The authors sought to investigate the impact of distal embolization (DE) on myocardial damage and microvascular reperfusion, according to time-to-treatment, using contrast-enhanced cardiac magnetic resonance (CE-CMR). Background DE, occurring during primary percutaneous coronary intervention (p-PCI), appears to increase myocardial necrosis and to worsen microvascular perfusion, as shown by surrogate markers. However, data regarding the behavior of DE on jeopardized myocardium, and in particular on necrosis extent and distribution, are still lacking. Methods In 288 patients who underwent p-PCI within 6 h from symptom onset, the authors prospectively assessed the impact of DE on infarct size and microvascular damage, using CE-CMR. The impact of DE was assessed according to time-to-treatment: for group 1, Ͻ3 h; for group 2, Ն3 and Յ6 h. Results DE occurred in 41 (14.3%) patients. Baseline clinical characteristics were not different between the 2 groups. At CE-CMR, patients with DE showed larger infarct size (p ϭ 0.038) and more often transmural necrosis compared with patients without DE (p ϭ 0.008) when time-to-treatment was Ͻ3 h, but no impact was proven after this time (p ϭ NS). Patients with DE showed more often microvascular obstruction, as evaluated at first-pass enhancement, than patients without DE (100% vs. 66.5%, p ϭ 0.001) up to 6 h from symptom onset. Conclusions These findings suggest that the detrimental impact of DE occurring during p-PCI on myocardial damage is largely influenced by ischemic time, increasing the extent of necrosis in patients presenting within the first hours after symptom onset, and having limited or no impact after this time window.

Research paper thumbnail of Transfemoral Aortic Valve Replacement With the Edwards SAPIEN and Edwards SAPIEN XT Prosthesis Using Exclusively Local Anesthesia and Fluoroscopic Guidance

JACC: Cardiovascular Interventions, 2012

Objectives The authors report the feasibility and 30-day outcomes of transfemoral aortic valve re... more Objectives The authors report the feasibility and 30-day outcomes of transfemoral aortic valve replacement (TAVR), using the Edwards SAPIEN (Edwards Lifesciences, Irvine, California) and Edwards SAPIEN XT (Edwards Lifesciences) prosthesis, implanted using exclusively local anesthesia and fluoroscopic guidance. Background Transfemoral TAVR is often managed with general anesthesia. However, a simplified percutaneous approach using local anesthesia has become more popular because it offers multiple advantages in an elderly and fragile population. Methods Between May 2006 and January 2011, the authors prospectively evaluated 151 consecutive patients (logistic EuroSCORE: 22.8 Ϯ 11.8%) who underwent TAVR (SAPIEN: n ϭ 78, SAPIEN XT: n ϭ 73) using only local anesthesia and fluoroscopic guidance. The primary endpoint was a combination of all-cause mortality, major stroke, life-threatening bleeding, stage 3 acute kidney injury (AKI), periprocedural myocardial infarction (MI), major vascular complication, and repeat procedure for valve-related dysfunction at 30 days. Results Transarterial femoral approach was surgical in all SAPIEN procedures and percutaneous in 97.3% of SAPIEN XT, using the ProStar vascular closure device, and was well tolerated in all cases. Conversion to general anesthesia was required in 3.3% (SAPIEN cases) and was related to complications. Vasopressors were required in 5.5%. Procedural success was 95.4%. The combined-safety endpoint was reached in 15.9%, including overall mortality (6.6%), major stroke (2.0%), life-threatening bleeding (7.9%), stage 3 AKI (0.7%), periprocedural MI (1.3%), major vascular complication (7.9%), and repeat procedure for valve-related dysfunction (2.0%) at 30 days. A permanent pacemaker was required in 5.3%. Conclusions This single-center, prospective registry demonstrated the feasibility and safety of a simplified transfemoral TAVR performed using only local anesthesia and fluoroscopic guidance in high surgical risk patients with severe aortic stenosis.

Research paper thumbnail of Transcatheter aortic valve implantation and bleeding: Focus on Valve Academic Research Consortium-2 classification

International Journal of Cardiology, 2013

Peri-procedural bleeding complications are feared adverse events in patients undergoing transcath... more Peri-procedural bleeding complications are feared adverse events in patients undergoing transcatheter aortic valve implantation (TAVI). Little is known about the implications of peri-procedural bleeding on clinical outcome. In a prospective single-center registry of consecutive patients undergoing TAVI, we investigated incidence, predictors and clinical consequences of life-threatening and major bleeding as defined by the Valve Academic Research Consortium. Among 389 consecutive patients undergoing TAVI by a transfemoral (79.2 %), transapical (19.6 %) or trans-subclavian (1.3 %) approach between July 2007 and October 2011, life-threatening or major peri-procedural bleeding events occurred in 64 (16.4 %) and 125 patients (32.1 %), respectively. Patients with peri-procedural bleeding events had a higher logistic EuroSCORE, more advanced renal disease, and were more symptomatic as assessed by New York Heart Association functional class at baseline as compared to patients with no bleeding. Lifethreatening bleeding was associated with a higher all-cause (17.2 vs 5.6 vs 3.0 %, p \ 0.001) and cardiovascular mortality (10.9 vs 5.6 vs 2.5 %, p = 0.02) at 30 days compared to patients with major bleeding or no bleeding. Multivariate analysis identified transapical access (OR 2.6, 95 % CI 1.4-4.8; p = 0.002), glomerular filtration rate \30 ml/min (OR 2.3, 95 % CI 1.1-4.7, p = 0.031), and diabetes (OR 1.8, 95 % CI 1.001-3.2, p = 0.049) as independent predictors of life-threatening, peri-procedural bleeding. Life-threatening bleeding complications in patients undergoing TAVI are associated with increased mortality. Renal impairment, diabetes, and transapical approach were identified as independent risk factors for life-threatening bleeding events.

Research paper thumbnail of Using wearable devices to monitor physical activity in patients undergoing aortic valve replacement: the CAPABILITY study protocol (Preprint)

BACKGROUND In the last decades, several tools have been developed to measure physical function ob... more BACKGROUND In the last decades, several tools have been developed to measure physical function objectively; however, their use has not been well established in clinical practice. OBJECTIVE The present study aims to describe the preoperative physical function and to assess and compare 6-month postoperative changes in the physical function of patients undergoing AS treatment with either surgical aortic valve replacement (SAVR) or transcatheter aortic valve replacement (TAVR) and to evaluate the feasibility of wearable devices in assessing physical function in such patients. METHODS Prospective observational study. The enrolment will be performed 1-month before TAVR/SAVR. Patients will be provided with the wearable device at baseline (activity tracker vívoactive® 3 devices by Garmin©). They will be trained in the use of the device, and they will be requested to wear it on the wrist of their preferred hand until 12-month after TAVR/SAVR. After baseline assessment, they will undergo four...

Research paper thumbnail of TCT-635 Unmasking Myocardial Bridge Related Ischemia by Intracoronary Functional Evaluation

Journal of the American College of Cardiology, 2018

eight patients (mean age 62AE13 years, 55% female, 39% ST-segment elevation) were included. Media... more eight patients (mean age 62AE13 years, 55% female, 39% ST-segment elevation) were included. Median worst diameter stenosis was 35% by angiography, and 5 patients (13%) had normal angiograms. Plaque disruption and coronary thrombus were observed in 9 patients (24%) and 7 patients (18%), respectively. Ischemic-type late gadolinium-enhancement was present in 7 of 31 patients (23%) undergoing CMR, and was more common in patients with versus without plaque disruption (50% vs. 13%, p¼0.053) and coronary thrombus (67% vs. 12%, p¼0.014). Whereas IRA showed significantly more plaque rupture, thrombus, eroded plaque, and thin-cap fibroatheroma, as well as less calcified plaque than the non-IRA, there were no differences in minimum lumen area and percentage stenosis on OCT. The immediate interpretation of the OCT resulted in modification of the initial treatment strategy in 6 of 38 patients (16%).

Research paper thumbnail of IFT09. Clinical Impact of Significant Carotid Stenosis in Patients Undergoing Transcatheter Aortic Valve Implantation

Journal of Vascular Surgery, 2019

Research paper thumbnail of 1-Year Clinical Outcomes in Women After Transcatheter Aortic Valve Replacement: Results From the First WIN-TAVI Registry

JACC. Cardiovascular interventions, Jan 8, 2018

This study sought to examine the safety and performance of contemporary transcatheter aortic valv... more This study sought to examine the safety and performance of contemporary transcatheter aortic valve replacement (TAVR) in an exclusive all-women TAVR population, and to further investigate the potential impact of female sex-specific characteristics on composite 1-year clinical outcomes. Women comprise ≥50% patients undergoing TAVR. Several data have shown the noninferiority of TAVR compared with surgical aortic valve replacement for symptomatic significant aortic stenosis, but no study so far has been specifically powered to detect differences by sex. The WIN-TAVI (Women's INternational Transcatheter Aortic Valve Implantation) registry is a multinational, prospective, observational registry of women undergoing TAVR for significant aortic stenosis, across 18 sites in Europe and 1 site in the United States, between January 2013 and December 2015. The primary Valve Academic Research Consortium (VARC)-2 efficacy endpoint was a composite of mortality, stroke, myocardial infarction, ho...

Research paper thumbnail of Long-term outcomes and prosthesis performance after transcatheter aortic valve replacement: results of self-expandable and balloon-expandable transcatheter heart valves

Annals of cardiothoracic surgery, 2017

Data on transcatheter aortic valve replacement (TAVR) long-term clinical outcomes and hemodynamic... more Data on transcatheter aortic valve replacement (TAVR) long-term clinical outcomes and hemodynamic performance of the self-expandable CoreValve (CV) and the balloon-expandable Edwards SAPIEN XT (ES) (Edwards Lifesciences, Irvine, California, USA) transcatheter heart valves (THV) are limited. Therefore, this study aimed to compare long-term clinical outcome data and hemodynamic performance of TAVR with either CV or ES. We reviewed prospectively collected data of 171 patients treated with TAVR for severe aortic stenosis (AS) at our center between June 2007 and December 2010, with last follow-up contact in 2016. Out of 171 patients treated with TAVR at our Institution, 87 received a CV and 84 an ES THV. Mean age was 81 [78-85] years, and mean Society of Thoracic Surgeons (STS) score was 7.5% (4.5-13.9%). Hemodynamic success by Valve Academic Research Consortium (VARC) definition was 97.1%. Mean trans-prosthetic gradient remained low and stable during follow-up in both groups (at 5-year ...

Research paper thumbnail of Transcatheter aortic valve implantation at institutions without cardiovascular surgery departments: many questions still linger before a paradigm shift

Journal of thoracic disease, 2016

Research paper thumbnail of Survival After Varying Revascularization Strategies in Patients With ST-Segment Elevation Myocardial Infarction and Multivessel Coronary Artery Disease

JACC: Cardiovascular Interventions, 2016

OBJECTIVES The authors conducted a systematic pairwise and network meta-analysis to assess optima... more OBJECTIVES The authors conducted a systematic pairwise and network meta-analysis to assess optimal treatment strategies in patients with ST-segment elevation myocardial infarction (STEMI) and multivessel coronary artery disease (MV-CAD) undergoing primary percutaneous coronary intervention (PCI). BACKGROUND Patients with STEMI and MV-CAD have a worse prognosis than those with single-vessel CAD. The optimal revascularization strategy for these patients is uncertain. METHODS Studies of revascularization strategies for MV-CAD in STEMI patients undergoing primary PCI published between 2001 and 2015 were identified using an electronic search. Pairwise and network meta-analyses were performed for 3 PCI strategies in prospective and retrospective studies: 1) infarct-related artery (IRA)-only PCI; 2) single procedure MV-PCI; and 3) staged MV-PCI. Information on study design, inclusion and exclusion criteria, and clinical outcomes was extracted. The outcomes of interest were short-term and long-term mortality. RESULTS Thirty-two studies (13 prospective and 19 retrospective) with 54,148 patients (IRA-only PCI [n ¼ 42,112], single procedure MV-PCI [n ¼ 8,138], and staged MV-PCI [n ¼ 3,898]) were included in the analysis. Pairwise metaanalyses showed that staged MV-PCI was associated with lower short-term and long-term mortality compared with both IRA-only PCI and single stage MV-PCI, whereas IRA-only PCI was associated with lower mortality compared with single stage MV-PCI. Staged MV-PCI was also associated consistently with improved survival in network analyses. CONCLUSIONS The present systematic review and meta-analysis supports the hypothesis that in patients with MV-CAD presenting with STEMI undergoing primary PCI, a staged multivessel revascularization strategy may improve early and late survival.

Research paper thumbnail of Acute and 30-Day Outcomes in Women After TAVR: Results From the WIN-TAVI (Women's INternational Transcatheter Aortic Valve Implantation) Real-World Registry

JACC. Cardiovascular interventions, Aug 8, 2016

The study sought to examine the safety and performance of transcatheter aortic valve replacement ... more The study sought to examine the safety and performance of transcatheter aortic valve replacement (TAVR) using an all-female registry and to further explore the potential impact of female sex-specific characteristics on clinical outcomes after TAVR. Although women comprise 50% of patients with symptomatic severe aortic stenosis undergoing TAVR, the optimal treatment strategy remains undetermined. The WIN-TAVI (Women's INternational Transcatheter Aortic Valve Implantation) registry is a multinational, prospective, observational registry of women undergoing TAVR for aortic stenosis, conducted without any external funding. The primary endpoint was the Valve Academic Research Consortium (VARC)-2 early safety endpoint at 30 days (composite of mortality, stroke, major vascular complication, life-threatening bleeding, stage 2 or 3 acute kidney injury, coronary artery obstruction, or repeat procedure for valve-related dysfunction). Between January 2013 and December 2015, 1,019 women were...

Research paper thumbnail of Early and Midterm Outcome of Propensity-Matched Intermediate-Risk Patients Aged ≥80 Years With Aortic Stenosis Undergoing Surgical or Transcatheter Aortic Valve Replacement (from the Italian Multicenter OBSERVANT Study)

The American Journal of Cardiology, 2016

Research paper thumbnail of Optimal duration of dual antiplatelet therapy after second-generation drug-eluting stent implantation in patients with diabetes: The SECURITY (Second-Generation Drug-Eluting Stent Implantation Followed By Six- Versus Twelve-Month Dual Antiplatelet Therapy)-diabetes substudy

International Journal of Cardiology, 2016

Optimal duration of dual antiplatelet therapy after secondgeneration drug-eluting stent implantat... more Optimal duration of dual antiplatelet therapy after secondgeneration drug-eluting stent implantation in patients with diabetes: The SECURITY (Second-Generation Drug-Eluting Stent Implantation Followed By Six-Versus Twelve-Month Dual Antiplatelet Therapy)-diabetes substudy,

Research paper thumbnail of Intermediate Clinical and Hemodynamic Outcomes After Transcatheter Aortic Valve Implantation

The Annals of Thoracic Surgery, 2016

Background. Concerns still exist regarding long-term results and freedom from valve-related adver... more Background. Concerns still exist regarding long-term results and freedom from valve-related adverse events in transcatheter aortic valve implantation (TAVI). The aim of this single-center retrospective study was to assess intermediate-term (up to 5-year) clinical and hemodynamic outcomes in patients undergoing TAVI. Methods. From 2007 through 2013, 338 consecutive patients underwent TAVI at our institution. Preoperative variables were defined according to the European System for Cardiac Operative Risk Evaluation (EuroSCORE) definitions, and outcomes were reported according to the Valve Academic Research Consortium (VARC)-2 definitions. Multivariate logistic regression analysis was performed to identify independent predictors of mortality at follow-up. Results. transfemoral (TF) and transapical (TA) TAVI were performed in 233 (69%) and 105 (31%) patients, respectively. All-cause 30-day mortality was 4.4%, with no differences between TA and TF procedures. Thirtyday cardiovascular death, stroke, and myocardial infarction were not different between groups. The acute kidney

Research paper thumbnail of Development and Validation of a Distal Embolization Risk Score During Primary Angioplasty in ST-Elevation Myocardial Infarction

The American Journal of Cardiology, 2015

This study aims to develop and validate a new angiographic risk score to predict the risk of dist... more This study aims to develop and validate a new angiographic risk score to predict the risk of distal embolization (DE) during primary percutaneous coronary intervention (p-PCI) for ST-elevation myocardial infarction. Study included data from 1,200 patients who underwent p-PCI. The cohort was randomly split into a derivation cohort (n = 814) and a validation cohort (n = 386). Logistic regression was used to examine the relation between risk factors and the occurrence of DE. To each covariate in the model was assigned an integer score based on the regression coefficients. Variables included in the risk score, according to multivariable analysis, were occlusion pattern of infarct-related artery, Thrombolysis In Myocardial Infarction Thrombus Score 2 to 4, reference vessel diameter ≥3.5 mm, and lesion length >20 mm. To each variable was assigned a 0- to +2-point score according to the strength of the statistical association. Rates of DE in low-, intermediate-, and high-risk groups were 5.6%, 15.8%, and 40% in the derivation cohort (p for trend <0.0001; C-statistic 0.70) and 7.5%, 12.1%, and 37.9% in the validation cohort (p for trend <0.0001; C-statistic 0.62), respectively. In conclusion, the individual risk of DE in patients who underwent p-PCI can be predicted using a simple 4-variables model based on angiographic features.

Research paper thumbnail of Long-term results of the amplatzer cribriform occluder for patent foramen ovale with associated atrial septal aneurysm: impact on occlusion rate and left atrial functional remodelling

American journal of cardiovascular disease, 2012

Treatment of patients with concomitant patent foramen ovale (PFO) and atrial septal aneurysm (ASA... more Treatment of patients with concomitant patent foramen ovale (PFO) and atrial septal aneurysm (ASA) poses a number of challenges; while some authors have suggested the off-label use of the Amplatzer Cribriform Occluder in such anatomy, the long-term outcomes of this strategy is unknown. Our study aimed to assess the long-term impact on closure rate, left atrial functional remodelling, and clinical outcomes of off-label implantation of Amplatzer ASD Cribriform Occluder in patients with PFO and ASA. We prospectively enrolled 160 consecutive patients with previous stroke (mean age 36 ± 9.5 years, 109 females), significant PFO and ASA. All patients were treated with Amplatzer Cribriform Occluder to ensure the most complete possible coverage of the ASA. Residual shunt and LA passive and active emptying, LA conduit function, and LA ejection fraction were computed before and after 6 months from the procedure and then yearly. All patients underwent successful transcatheter closure (mean rati...

Research paper thumbnail of Prospective analysis of 30-day safety and performance of transfemoral transcatheter aortic valve implantation with Edwards SAPIEN XT versus SAPIEN prostheses

Archives of Cardiovascular Diseases, 2012

Background.-A new generation of balloon-expandable valves (e.g. Edwards SAPIEN XT) enables the us... more Background.-A new generation of balloon-expandable valves (e.g. Edwards SAPIEN XT) enables the use of a decreased sheath size using the NovaFlex TM delivery system for transfemoral transcatheter aortic valve implantation (TAVI). However, there are few data analysing the efficacy and safety of this new prosthesis.

Research paper thumbnail of Comparison of Balloon-Expandable Versus Self-Expandable Valves for Transcatheter Aortic Valve Implantation in Patients With Low-Gradient Severe Aortic Stenosis and Preserved Left Ventricular Ejection Fraction

The American Journal of Cardiology, 2015

A relevant proportion of patients, classified as severe aortic stenosis on the basis of valve are... more A relevant proportion of patients, classified as severe aortic stenosis on the basis of valve area £1 cm 2 , have a mean transvalvular gradient £40 mm Hg, despite a preserved left ventricular ejection fraction (LGSAS). We assessed the clinical and hemodynamic impact of transcatheter aortic valve implantation in patients with symptomatic LGSAS at high risk for surgery or inoperable, according to the type of percutaneous valve implanted. Ninetyfive patients received an Edwards SAPIEN valve (Edwards Lifesciences, Irvine, California) and 51 received a Medtronic CoreValve (Medtronic, Inc., Minneapolis, Minnesota). The hemodynamic performance of the 2 valves was similar in term of final transvalvular gradients (10 mm Hg, p [ 0.069). Early mortality rate was 7% and was not different between the 2 valves (p [ 0.73). During follow-up, cardiovascular mortality rate was similar between groups, and valve type was not a predictor of outcome (p [ 0.72). Estimated survival by KaplaneMeier at 2 years was 70%. At multivariate analysis, lifethreatening or major bleeding, postprocedural aortic insufficiency, and acute kidney injury were the major predictors of an adverse outcome. In patients with LGSAS treated by transcatheter aortic valve implantation, the use of balloon-expandable versus selfexpandable valves resulted in similar hemodynamic, early, and long-term clinical outcomes.

Research paper thumbnail of Acute Coronary Syndrome With Clear Coronary Artery

JACC: Cardiovascular Interventions, 2010

A 67-year-old obese woman with a history of hypertension and dyslipidemia was admitted at our ins... more A 67-year-old obese woman with a history of hypertension and dyslipidemia was admitted at our institution because of non-ST-segment elevation myocardial infarction. Electrocardiography at admission showed flat T waves in inferiorlateral leads. Two-dimensional transthoracic echocardi-ography revealed infero-lateral wall hypokinesia. Troponin I peaked at 18 g/l. Coronary angiography showed patent coronary arteries without significant stenoses and with Thrombolysis In Myocardial Infarction (TIMI) flow grade 3. Indeed, an intermediate tubular lesion with smooth

Research paper thumbnail of Expanding the Eligibility for Transcatheter Aortic Valve Implantation

JACC: Cardiovascular Interventions, 2009

Objectives Our aim was to assess the safety and feasibility of the retrograde trans-subclavian ap... more Objectives Our aim was to assess the safety and feasibility of the retrograde trans-subclavian approach to transcatheter aortic valve implantation (TAVI) in selected high-risk patients with aortic stenosis (AS) and severe peripheral vasculopathy. Background TAVI is an emerging therapeutic option to treat inoperable/high-risk patients affected by symptomatic AS. However, these patients are also often affected by severe iliac-femoral arteriopathy, rendering the transfemoral approach unemployable for percutaneous revalving procedure. Methods From among those patients in our department between May 2007 and December 2008, who were refused surgical aortic valve replacement because of high surgical risk and were ineligible for transfemoral percutaneous aortic valve replacement, we scheduled 3 for TAVI by the subclavian approach. Procedures were performed by a combined team of cardiologists, cardiac surgeons, and anesthetists in the catheterization laboratory. The III generation CoreValve Revalving System (Core-Valve Inc., Irvine, California) with an 18-F delivery system was introduced in all cases by the left subclavian artery. Results Prosthetic valves were successfully implanted in all 3 cases, leading to a fall in transvalvular gradient without significant paravalvular regurgitation. No intraprocedural or periprocedural complications occurred. Two patients developed an atrioventricular block requiring the implantation of a permanent pacemaker. All patients were discharged in asymptomatic status, with good prosthesis performance. No adverse events occurred within the 3-month follow-up. Conclusions TAVI by subclavian retrograde approach seems safe and feasible in inoperable/high-risk patients with AS and peripheral vasculopathy, who are neither eligible for surgical valve replacement nor transfemoral percutaneous aortic valve implantation. Further studies are needed to evaluate the longterm efficacy of this new therapy.

Research paper thumbnail of Time-Dependent Detrimental Effects of Distal Embolization on Myocardium and Microvasculature During Primary Percutaneous Coronary Intervention

JACC: Cardiovascular Interventions, 2012

Objectives The authors sought to investigate the impact of distal embolization (DE) on myocardial... more Objectives The authors sought to investigate the impact of distal embolization (DE) on myocardial damage and microvascular reperfusion, according to time-to-treatment, using contrast-enhanced cardiac magnetic resonance (CE-CMR). Background DE, occurring during primary percutaneous coronary intervention (p-PCI), appears to increase myocardial necrosis and to worsen microvascular perfusion, as shown by surrogate markers. However, data regarding the behavior of DE on jeopardized myocardium, and in particular on necrosis extent and distribution, are still lacking. Methods In 288 patients who underwent p-PCI within 6 h from symptom onset, the authors prospectively assessed the impact of DE on infarct size and microvascular damage, using CE-CMR. The impact of DE was assessed according to time-to-treatment: for group 1, Ͻ3 h; for group 2, Ն3 and Յ6 h. Results DE occurred in 41 (14.3%) patients. Baseline clinical characteristics were not different between the 2 groups. At CE-CMR, patients with DE showed larger infarct size (p ϭ 0.038) and more often transmural necrosis compared with patients without DE (p ϭ 0.008) when time-to-treatment was Ͻ3 h, but no impact was proven after this time (p ϭ NS). Patients with DE showed more often microvascular obstruction, as evaluated at first-pass enhancement, than patients without DE (100% vs. 66.5%, p ϭ 0.001) up to 6 h from symptom onset. Conclusions These findings suggest that the detrimental impact of DE occurring during p-PCI on myocardial damage is largely influenced by ischemic time, increasing the extent of necrosis in patients presenting within the first hours after symptom onset, and having limited or no impact after this time window.

Research paper thumbnail of Transfemoral Aortic Valve Replacement With the Edwards SAPIEN and Edwards SAPIEN XT Prosthesis Using Exclusively Local Anesthesia and Fluoroscopic Guidance

JACC: Cardiovascular Interventions, 2012

Objectives The authors report the feasibility and 30-day outcomes of transfemoral aortic valve re... more Objectives The authors report the feasibility and 30-day outcomes of transfemoral aortic valve replacement (TAVR), using the Edwards SAPIEN (Edwards Lifesciences, Irvine, California) and Edwards SAPIEN XT (Edwards Lifesciences) prosthesis, implanted using exclusively local anesthesia and fluoroscopic guidance. Background Transfemoral TAVR is often managed with general anesthesia. However, a simplified percutaneous approach using local anesthesia has become more popular because it offers multiple advantages in an elderly and fragile population. Methods Between May 2006 and January 2011, the authors prospectively evaluated 151 consecutive patients (logistic EuroSCORE: 22.8 Ϯ 11.8%) who underwent TAVR (SAPIEN: n ϭ 78, SAPIEN XT: n ϭ 73) using only local anesthesia and fluoroscopic guidance. The primary endpoint was a combination of all-cause mortality, major stroke, life-threatening bleeding, stage 3 acute kidney injury (AKI), periprocedural myocardial infarction (MI), major vascular complication, and repeat procedure for valve-related dysfunction at 30 days. Results Transarterial femoral approach was surgical in all SAPIEN procedures and percutaneous in 97.3% of SAPIEN XT, using the ProStar vascular closure device, and was well tolerated in all cases. Conversion to general anesthesia was required in 3.3% (SAPIEN cases) and was related to complications. Vasopressors were required in 5.5%. Procedural success was 95.4%. The combined-safety endpoint was reached in 15.9%, including overall mortality (6.6%), major stroke (2.0%), life-threatening bleeding (7.9%), stage 3 AKI (0.7%), periprocedural MI (1.3%), major vascular complication (7.9%), and repeat procedure for valve-related dysfunction (2.0%) at 30 days. A permanent pacemaker was required in 5.3%. Conclusions This single-center, prospective registry demonstrated the feasibility and safety of a simplified transfemoral TAVR performed using only local anesthesia and fluoroscopic guidance in high surgical risk patients with severe aortic stenosis.

Research paper thumbnail of Transcatheter aortic valve implantation and bleeding: Focus on Valve Academic Research Consortium-2 classification

International Journal of Cardiology, 2013

Peri-procedural bleeding complications are feared adverse events in patients undergoing transcath... more Peri-procedural bleeding complications are feared adverse events in patients undergoing transcatheter aortic valve implantation (TAVI). Little is known about the implications of peri-procedural bleeding on clinical outcome. In a prospective single-center registry of consecutive patients undergoing TAVI, we investigated incidence, predictors and clinical consequences of life-threatening and major bleeding as defined by the Valve Academic Research Consortium. Among 389 consecutive patients undergoing TAVI by a transfemoral (79.2 %), transapical (19.6 %) or trans-subclavian (1.3 %) approach between July 2007 and October 2011, life-threatening or major peri-procedural bleeding events occurred in 64 (16.4 %) and 125 patients (32.1 %), respectively. Patients with peri-procedural bleeding events had a higher logistic EuroSCORE, more advanced renal disease, and were more symptomatic as assessed by New York Heart Association functional class at baseline as compared to patients with no bleeding. Lifethreatening bleeding was associated with a higher all-cause (17.2 vs 5.6 vs 3.0 %, p \ 0.001) and cardiovascular mortality (10.9 vs 5.6 vs 2.5 %, p = 0.02) at 30 days compared to patients with major bleeding or no bleeding. Multivariate analysis identified transapical access (OR 2.6, 95 % CI 1.4-4.8; p = 0.002), glomerular filtration rate \30 ml/min (OR 2.3, 95 % CI 1.1-4.7, p = 0.031), and diabetes (OR 1.8, 95 % CI 1.001-3.2, p = 0.049) as independent predictors of life-threatening, peri-procedural bleeding. Life-threatening bleeding complications in patients undergoing TAVI are associated with increased mortality. Renal impairment, diabetes, and transapical approach were identified as independent risk factors for life-threatening bleeding events.