Impact of vascular complications after transcatheter aortic valve implantation. VASC-OBSERVANT II sub-study.

BACKGROUND: Trans-femoral (TF) access is the commonest approach for transcatheter aortic valve implantation (TAVI). However this vascular approach is associated with vascular complications (VC) which in turn have prognostic implications. The aim of this study is to evaluate the clinical impact of access site VC in patients undergoing TAVI with newer generation transcatheter prostheses enrolled in the national observational prospective multicenter study OBSERVANT II. METHODS: Vascular events were defined according to the Valve Academic Research Consortium (VARC)-2 criteria. The population enrolled in OBSERVANT II was divided into 3 groups: patients without VC (No-VC), patients with minor VC or percutaneous closure device failure (Minor-VC) and patients with major VC (Major-VC). The primary endpoint was 1-year major adverse cardiac and cerebrovascular event (MACCE), a composite endpoint of all-cause mortality, stroke, myocardial infarction and coronary revascularization. A multivariate Cox regression model was used for risk estimation of MACCE between the three analyzed groups. RESULTS: 2.504 patients were included in this analysis: 2.167 patients in No-VC group; 249 patients in the Minor-VC and 88 patients in the Major-VC. At 1-year Minor-VC group had a freedom from MACCE comparable to the No-VC group, while Major-VC patients had significantly worse outcome (Log-rank test: p = 0.003). These results were driven by higher 1-year mortality in the Major-VC (p < 0.0001). Major-VC was an independent predictor of MACCE in adjusted analysis (hazard ratio 1.89, 95% confidence interval 1.18-3.03, p = 0.008). CONCLUSIONS: Despite a low incidence of major VC with current TF-TAVI devices, our data confirm that major VC is still associated with a significantly worse clinical outcome.

Intracardiac echocardiography for guidance of transcatheter left atrial appendage occlusion: An expert consensus document.

Transcatheter left atrial appendage occlusion (LAAO) is an increasingly used alternative to oral anticoagulation in selected patients with atrial fibrillation. Intraprocedural imaging is a crucial for a successful intervention, with transesophageal echocardiography (TEE) as the current gold standard. Since some important limitations may affect TEE use, intracardiac echocardiography (ICE) is increasingly used as an alternative to TEE for guiding LAAO. The lack of a standardized imaging protocol has slowed the adoption of ICE into clinical practice. On the basis of current research and expert consensus, this paper provides a protocol for ICE support of left atrial appendage occlusion.

Factors influencing the choice between transcatheter and surgical treatment of severe aortic stenosis in patients younger than 80 years: Results from the OBSERVANT study.

OBJECTIVES: We aimed to analyze the baseline features and clinical outcomes of patients younger than 80 years undergoing transfemoral transcatheter aortic valve implantation (TAVI) or surgical aortic valve replacement (SAVR) enrolled in the OBservational Study of Effectiveness of SAVR-TAVR procedures for severe Aortic steNosis Treatment (OBSERVANT) real-world study, focusing on variables guiding Heart Team decision toward TAVI. BACKGROUND: Patients treated with TAVI, independently of surgical risk score, are mostly older than 80 years. METHODS: OBSERVANT is a multicenter, observational, prospective cohort study that enrolled patients with symptomatic severe aortic stenosis (AS) who underwent SAVR or TAVI from December 2010 to June 2012 in 93 Italian participating hospitals. For this analysis, baseline characteristics, therapeutic approach and outcomes up to 5 years of follow-up of 4,801 patients under 80 years of age were collected. Patients were stratified by age classes (<65, 65-74, and 75-79 years). RESULTS: Patients <80 years of age with severe symptomatic AS undergoing TAVI (n = 483) had significantly higher Logistic EuroSCORE (10.84% vs. 5.22%, p < .001) and prevalence of comorbidities compared to subjects undergoing SAVR (n = 4,318). The decision to perform TAVI over SAVR was driven by anatomical factors, mainly previous cardiac surgery (odds ratio [OR] 24.73, confidence interval [CI] 12.71-48.10, p < .001) and the presence of porcelain aorta (OR 17.44, CI 6.67-45.55, p < .001), and clinical factors, mainly moderate-severe frailty score (OR 5.49, CI 3.33-9.07, p < .001), oxygen dependency (OR 7.42, CI 2.75-20.04, p < .001) and need for dialytic treatment (OR 5.24, CI 1.54-17.80, p < .008). Among patients undergoing TAVI, those under 65 years had the highest baseline risk profile (despite a low Logistic EuroSCORE) and the highest 5-year mortality compared to those 65-74 and 75-79-year-old (65.22% vs. 48.54% vs. 55.24%, log-rank p = .061). CONCLUSION: Among patients under 80 years of age with symptomatic severe AS, only 10% underwent TAVI. These patients were at higher baseline risk compared to those undergoing SAVR. The decision to perform TAVI was driven by the presence of both anatomical and clinical factors beyond surgical risk scores. Patients under 65 years of age, despite the low Logistic EuroSCORE, had the highest preoperative risk profile and carried the worse outcome.

Comprehensive geriatric assessment in patients undergoing transcatheter aortic valve implantation - results from the CGA-TAVI multicentre registry.

BACKGROUND: In older patients with aortic stenosis (AS) undergoing TAVI, the potential role of prior CGA is not well established. To explore the value of comprehensive geriatric assessment (CGA) for predicting mortality and/or hospitalisation within the first 3 months after transcatheter aortic valve implantation (TAVI). METHODS: An international, multi-centre, prospective registry (CGA-TAVI) was established to gather data on CGA results and medium-term outcomes in geriatric patients undergoing TAVI. Logistic regression was used to evaluate the predictive value of a multidimensional prognostic index (MPI); a short physical performance battery (SPPB); and the Silver Code, which was based on administrative data, for predicting death and/or hospitalisation in the first 3 months after TAVI (primary endpoint). RESULTS: A total of 71 TAVI patients (mean age 85.4 years; mean log EuroSCORE I 22.5%) were enrolled. Device success according to VARC criteria was 100%. After adjustment for selected baseline characteristics, a higher (poorer) MPI score (OR: 3.34; 95% CI: 1.39-8.02; p = 0.0068) and a lower (poorer) SPPB score (OR: 1.15; 95% CI: 1.01-1.54; p = 0.0380) were found to be associated with an increased likelihood of the primary endpoint. The Silver Code did not show any predictive ability in this population. CONCLUSIONS: Several aspects of the CGA have shown promise for being of use to physicians when predicting TAVI outcomes. While the MPI may be useful in clinical practice, the SPPB may be of particular value, being simple and quick to perform. Validation of these findings in a larger sample is warranted. TRIAL REGISTRATION: The trial was registered in ClinicalTrials.gov on November 7, 2013 ( NCT01991444 ).

Transcatheter aortic valve implantation compared with surgical aortic valve replacement in patients with anaemia.

OBJECTIVES: We compared the outcome of anaemic patients undergoing transcatheter (TAVI) and surgical aortic valve replacement (SAVR) for severe aortic valve stenosis. METHODS: Anaemic patients (haemoglobin <13.0 g/dL in men and <12.0 g/dL in women) undergoing TAVI and SAVR from the OBSERVANT study were the subjects of this analysis. RESULTS: Preoperative anaemia was an independent predictor of 3-year mortality after either TAVI (HR 1.37, 95% CI 1.12-1.68) and SAVR (HR 1.63, 95% CI 1.37-1.99). Propensity score matching resulted in 302 pairs with similar characteristics. Patients undergoing SAVR had similar 30-d mortality (3.6% versus 3.3%, p = .81) and stroke (1.3% versus 2.0%, p = .53) compared with TAVI. The rates of pacemaker implantation (18.6% versus 3.0%, p < .001), major vascular damage (5.7% versus 0.4%, p < .001) and mild-to-severe paravalvular regurgitation (47.4% versus 9.3%, p < .001) were higher after TAVI, whereas acute kidney injury (50.7% versus 27.9%, p < .001) and blood transfusion (70.0% versus 38.6%, p < .001) were more frequent after SAVR. At 3-year, survival was 74.0% after SAVR and 66.3% after TAVI, respectively (p = .065), and freedom from MACCE was 67.6% after SAVR and 58.7% after TAVI, respectively (p = .049). CONCLUSIONS: These results suggest that TAVI is not superior to SAVR in patients with anaemia.

Outcome After General Anesthesia Versus Monitored Anesthesia Care in Transfemoral Transcatheter Aortic Valve Replacement.

OBJECTIVE: To evaluate outcomes of monitored anesthesia care (MAC) compared with general anesthesia (GA) in patients undergoing transfemoral transcatheter aortic valve replacement (TAVR). DESIGN: Secondary analysis from the observational and prospective OBSERVANT (OBservational Study of Effectiveness of avR-taVi procedures for severe Aortic steNosis Treatment) study. SETTING: Multicenter study, including Italian hospitals performing TAVR interventions. PARTICIPANTS: One thousand four hundred ninety-four patients with severe and symptomatic aortic stenosis. INTERVENTIONS: Transfemoral TAVR under general or local anesthesia. MEASUREMENTS AND MAIN RESULTS: A propensity score procedure was applied, and 310 pairs were matched with similar baseline characteristics (EuroSCORE II: local anesthesia 6.6±5.9% v general anesthesia 7.0±7.7%, p = 0.430). MAC was associated with similar 30-day mortality compared with GA (3.9% v 4.8%, p = 0.564). TAVR was performed under MAC without any increased risk of other adverse events. The risk of paravalvular regurgitation≥mild was similar between the study groups (MAC 49.5% v general anesthesia 57.0%, p = 0.858). Two patients receiving on MAC had severe paravalvular regurgitation, whereas this complication was not observed after GA. Permanent pacemaker implantation was 19.1% in the MAC group v 14.8% in the GA group (p = 0.168). Mean intensive care unit stay was 3.5 days for the GA group v 2.9 days for the MAC group (p = 0.086). A similar 3-year survival rate was observed (MAC 69.4% v GA 69.9%, p = 0.966). CONCLUSIONS: Transfemoral TAVR can be performed under MAC with similar immediate and late outcomes as compared with GA. A possible risk of severe paravalvular regurgitation and pacemaker implantation with TAVR under MAC requires further investigation.

Management of patients with patent foramen ovale and cryptogenic stroke: a collaborative, multidisciplinary, position paper.

OBJECTIVES: To organize a common approach on the management of patent foramen ovale (PFO) and cryptogenic stroke that may be shared by different specialists. BACKGROUND: The management of PFO related to cryptogenic stroke is controversial, despite an increase in interventional closure procedures. METHODS: A consensus statement was developed by approaching Italian national cardiological, neurological, and hematological scientific societies. Task force members were identified by the president and/or the boards of each relevant scientific society or working group, as appropriate. Drafts were outlined by specific task force working groups. To obtain a widespread consensus, these drafts were merged and distributed to the scientific societies for local evaluation and revision by as many experts as possible. The ensuing final draft, merging all the revisions, was reviewed by the task force and finally approved by scientific societies. RESULTS: Definitions of transient ischemic attack and both symptomatic and asymptomatic cryptogenic strokes were specified. A diagnostic workout was identified for patients with candidate event(s) and patient foramen ovale to define the probable pathogenesis of clinical events and to describe individual PFO characteristics. Further recommendations were provided regarding medical and interventional therapy considering individual risk factors of recurrence. Finally, follow-up evaluation was appraised. CONCLUSIONS: Available data provided the basis for a shared approach to management of cryptogenic ischemic cerebral events and PFO among different Italian scientific societies. Wider international initiatives on the topic are awaited.

Management of patients with patent foramen ovale and cryptogenic stroke: a collaborative, multidisciplinary, position paper: executive summary.

OBJECTIVES: To organize a common approach on the management of patent foramen ovale (PFO) and cryptogenic stroke that may be shared by different specialists. BACKGROUND: The management of PFO related to cryptogenic stroke is controversial, despite an increase in interventional closure procedures. METHODS: A consensus statement was developed by approaching Italian national cardiological, neurological, and hematological scientific societies. Task force members were identified by the president and/or the boards of each relevant scientific society or working group, as appropriate. Drafts were outlined by specific task force working groups. To obtain a widespread consensus, these drafts were merged and distributed to the scientific societies for local evaluation and revision by as many experts as possible. The ensuing final draft, merging all the revisions, was reviewed by the task force and finally approved by scientific societies. RESULTS: Definitions of transient ischemic attack and both symptomatic and asymptomatic cryptogenic strokes were specified. A diagnostic workout was identified for patients with candidate event(s) and patient foramen ovale to define the probable pathogenesis of clinical events and to describe individual PFO characteristics. Further recommendations were provided regarding medical and interventional therapy considering individual risk factors of recurrence. Finally, follow-up evaluation was appraised. CONCLUSIONS: Available data provided the basis for a shared approach to management of cryptogenic ischemic cerebral events and PFO among different Italian scientific societies. Wider international initiatives on the topic are awaited.

Transcatheter aortic valve implantation: 3-year outcomes of self-expanding CoreValve prosthesis.

AIMS: The paucity of evidences about the long-term durability of currently available transcatheter prostheses is one of the main issues of transcatheter aortic valve implantation (TAVI). We sought to assess 3-year clinical and echocardiographic outcomes of patients undergoing TAVI with the third generation CoreValve prosthesis (Medtronic Incorporation, MN, USA). METHODS AND RESULTS: From the Italian CoreValve registry, 181 who underwent TAVI from June 2007 to August 2008 and eligible for 3-year follow-up were analysed. All outcomes were defined according to the Valve Academic Research Consortium. All-cause mortality at 1, 2, and 3 years was 23.6, 30.3, and 34.8%, respectively. Cardiovascular death at 1, 2, and 3 years was 11.2, 12.1, and 13.5%, respectively. The actuarial survival free from a composite of death, major stroke, myocardial infarction, and life-threatening bleeding was 69.6% at 1 year, 63.5% at 2 years, and 59.7% at 3 years. Patients with renal insufficiency had a higher mortality at 3-year follow-up (49.0 vs. 29.2%, P = 0.007); moreover, patients experiencing post-procedural major or life-threatening bleeding had a higher rate of mortality already seen at 30 days (21.6 vs. 2.8%; P < 0.001) and this result was sustained at 3-year follow-up (62.2 vs. 27.7%; P < 0.001). Mean pressure gradients decreased from 52.2 ± 18.1 mmHg (pre-TAVI) to 10.3 ± 3.1 mmHg (1-year post-TAVI) (P < 0.001); aortic valve area increased from 0.6 ± 0.2 cm(2) (pre-TAVI) to 1.8 ± 0.4 cm(2) (1-year post-TAVI); these results remained stable over the 3 years of follow-up. Paravalvular leak was observed in the majority of patients. There were no cases of progression to moderate or severe regurgitation. No cases of structural valve deterioration were observed. CONCLUSION: This multicentre study demonstrates that TAVI with the 18-Fr CoreValve ReValving System is associated with sustained clinical and functional cardiovascular benefits in high-risk patients with symptomatic aortic stenosis up to 3-year follow-up. Non-cardiac causes accounted for the majority of deaths at follow-up.

Residual shunt after patent foramen ovale closure: preliminary results from Italian patent foramen ovale survey.

BACKGROUND: Percutaneous patent foramen ovale (PFO) closure is accepted as treatment for cryptogenic ischemic stroke/transient ischemic attack in young subjects. However, a thorough evaluation of residual right-to-left shunt (rRLS) after PFO closure is needed. Our aims were to analyze the characteristics related to PFO diagnosis and closure, focusing on rRLS and clinical recurrences until 24-month follow-up. Data were extrapolated from the 12-month Italian PFO Survey. METHODS: In all, 1035 patients were included. PFO diagnosis and right-to-left shunt (RLS) were assessed by contrast-enhanced transesophageal and/or transthoracic echocardiography and/or transcranial Doppler. RESULTS: PFO diagnosis with RLS data were available in 894 of 1035 (86.4%) patients. rRLS was investigated in 49.6% (6 months), 27.1% (12 months), and 3.5% (24 months), and observed in 19.5% (6 months) and 18.2% (12 months) of subjects. Large permanent rRLS was observed in less than 3% of RLS-positive patients after 1 year. Eleven of 14 and 3 of 14 neurological recurrences were observed in 10 of 444 (2.25%) and 2 of 243 (0.8%) patients within the 6- and 12-month follow-up, respectively. Among these, no large rRLS was reported. There were no neurological events at 2-year follow-up. Forty of 444 subjects had non-neurological complications, mostly cardiac arrhythmias within the sixth month. CONCLUSIONS: PFO closure is a safe procedure. rRLS is not uncommon but large rRLS is rare. Clinical complications, mostly related to cardiac arrhythmias, are not unusual. Evaluation of the data of the whole survey is underway.

Impact of Chronic Coronary Artery Disease and Revascularization Strategy in Patients with Severe Aortic Stenosis Who Underwent Transcatheter Aortic Valve Implantation.

The prognostic impact of coronary artery disease (CAD) after transcatheter aortic valve implantation (TAVI) is controversial. The aim of this study is to investigate the impact of CAD and different revascularization strategies on clinical outcomes in patients who underwent TAVI with third generation devices. Patients enrolled in the national observational Observational Study of Effectiveness of SAVR-TAVI Procedures for Severe Aortic Stenosis Treatment II study were stratified according to the presence of CAD (CAD+, n = 1,130) versus no CAD (CAD-, n = 1,505), and compared using a propensity matched analysis. CAD+ group was further stratified according to the revascularization strategy: no revascularization (n = 331), revascularization performed >90 days before index-TAVI (n = 417) and coronary revascularization performed <90 days before index-TAVI or during TAVI (n = 382). In-hospital, 30-day and 1-year clinical outcomes were estimated. The mean age of the overall population was 81.8 years; 54.9% of patients were female. Propensity score matching yielded 813 pairs and their 30-day all-cause mortality was comparable (p = 0.480). Major periprocedural adverse events were also similar between the groups. At 1-year follow-up, the rate of major adverse cardiac and cerebrovascular events (MACCEs) and all-cause mortality were similar between the groups (p = 0.732 and p = 0.633, respectively). Conversely, patients with CAD experienced more often myocardial infarction and need for percutaneous coronary intervention at 1 year (p = 0.007 and p = 0.001, respectively). Neither CAD nor revascularization strategy were independent predictors of 1-year MACCE. About 40% of patients presenting with severe AS and who underwent TAVI had concomitant CAD. The presence of CAD had no impact on all-cause mortality and MACCE 1-year after TAVR. However, CAD carries a higher risk for acute myocardial infarction and need of percutaneous coronary intervention during follow-up.

Incidence and predictors of early and late mortality after transcatheter aortic valve implantation in 663 patients with severe aortic stenosis.

BACKGROUND: There is a lack of information on the incidence and predictors of early mortality at 30 days and late mortality between 30 days and 1 year after transcatheter aortic valve implantation (TAVI) with the self-expanding CoreValve Revalving prosthesis. METHODS AND RESULTS: A total of 663 consecutive patients (mean age 81.0 ± 7.3 years) underwent TAVI with the third generation 18-Fr CoreValve device in 14 centers. Procedural success and intraprocedural mortality were 98% and 0.9%, respectively. The cumulative incidences of mortality were 5.4% at 30 days, 12.2% at 6 months, and 15.0% at 1 year. The incidence density of mortality was 12.3 per 100 person-year of observation. Clinical and hemodynamic benefits observed acutely after TAVI were sustained at 1 year. Paravalvular leakages were trace to mild in the majority of cases. Conversion to open heart surgery (odds ratio [OR] 38.68), cardiac tamponade (OR 10.97), major access site complications (OR 8.47), left ventricular ejection fraction <40% (OR 3.51), prior balloon valvuloplasty (OR 2.87), and diabetes mellitus (OR 2.66) were independent predictors of mortality at 30 days, whereas prior stroke (hazard ratio [HR] 5.47), postprocedural paravalvular leak ≥ 2+ (HR 3.79), prior acute pulmonary edema (HR 2.70), and chronic kidney disease (HR 2.53) were independent predictors of mortality between 30 days and 1 year. CONCLUSIONS: Benefit of TAVI with the CoreValve Revalving System is maintained over time up to 1 year, with acceptable mortality rates at various time points. Although procedural complications are strongly associated with early mortality at 30 days, comorbidities and postprocedural paravalvular aortic regurgitation ≥ 2+ mainly impact late outcomes between 30 days and 1 year.

[Italian Society of Interventional Cardiology (SICI-GISE) Position paper: Transcatheter left atrial appendage occlusion in patients with non-valvular atrial fibrillation]. / Documento di posizione della Società Italiana di Cardiologia Interventistica (SICI-GISE): Chiusura percutanea dell'auricola sinistra in pazienti affetti da fibrillazione atriale non valvolare.

Atrial fibrillation (AF) is the most common arrhythmia worldwide. Thromboembolism from the left atrial appendage (LAA) is the most feared complication in patients with AF. The cornerstone for the management of AF is oral anticoagulation to reduce the incidence of cardioembolic stroke. There is, however, a significant proportion of patients who cannot undergo long-term oral anticoagulation. Transcatheter LAA occlusion is an evolving technology with proven benefits in terms of AF-related stroke prevention, representing a valid alternative to anticoagulation for high-risk patients with contraindications for long-term oral anticoagulation. This has resulted in the development of a plethora of transcatheter devices to achieve endocardial occlusion or epicardial exclusion of the LAA.A panel of expert Italian cardiologists gathered under the aegis of the Italian Society of Interventional Cardiology (SICI-GISE) with the aim of reviewing the most relevant aspects of LAA occlusion, underlying anatomy and pathophysiology, summarizing current clinical knowledge, and discussing the practicalities of available devices and imaging techniques. Finally, the position paper highlights the importance of an adequate environment and of an appropriate organization in order to optimize all steps of the procedure.

Real-World Multiple Comparison of Transcatheter Aortic Valves: Insights From the Multicenter OBSERVANT II Study.

BACKGROUND: Head-to-head comparisons of devices for transcatheter aortic valve implantation (TAVI) are mostly limited to 2-arm studies so far. The aim of this study was to compare simultaneously outcomes of the most used, second- and third-generation transcatheter aortic valves in a real-world population. METHODS: A total of 2728 patients undergoing TAVI with different second- and third-generation devices, and enrolled in the multicenter, prospective OBSERVANT II study (Observational Study of Effectiveness of TAVI With New Generation Devices for Severe Aortic Stenosis Treatment) from December 2016 to September 2018 were compared according to the transcatheter aortic valve received. Outcomes were adjudicated through a linkage with administrative databases, and adjusted using inverse propensity of treatment weighting. The primary end point was the composite of all-cause death, stroke and rehospitalization for heart failure at 1-year. Rates were reported consecutively for Evolut R, Evolut PRO, SAPIEN 3, ACURATE neo, and Portico groups. RESULTS: The primary end point did not differ among groups (23.9% versus 24.7% versus 21.5% versus 23.7% versus 27.4%, respectively, P=0.56). Permanent pacemaker implantation was significantly lower for patients receiving SAPIEN 3 (19.9% versus 19.3% versus 12.5% versus 14.7% versus 22.1%, respectively, P<0.01) at 1 year. The SAPIEN 3 had lower rates of paravalvular regurgitation (moderate-to-severe grade 10.1% versus 5.0% versus 2.1% versus 13.1% versus 10.8%, respectively, P<0.01) but higher transprosthetic gradients (median mean gradients 7.0 versus 6.0 versus 10.0 versus 7.0 versus 8.0 mm Hg, respectively, P<0.01) after TAVI. CONCLUSIONS: Data from real-world practice showed low and comparable rates of complications after TAVI considering all the available devices. Patients receiving SAPIEN 3 valve had lower rates of paravalvular regurgitation and permanent pacemaker implantation, but higher transprosthetic gradients.

One-Year Outcomes and Trends over Two Eras of Transcatheter Aortic Valve Implantation in Real-World Practice.

BACKGROUND: Data reflecting the benefit of procedural improvements in real-world transcatheter aortic valve implantation (TAVI) practice are sparse. AIMS: To compare outcomes and trends of two TAVI eras from real Italian practice. METHODS: A total of 1811 and 2939 TAVI patients enrolled in the national, prospective OBSERVANT and OBSERVANT II studies in 2010-2012 and 2016-2018, respectively, were compared in a cohort study. Outcomes were adjusted using inverse propensity of treatment weighting and propensity score matching. RESULTS: The median age (83.0 (79.0-86.0) vs. 83.0 (79.0-86.0)) and EuroSCORE II (5.2 (3.2-7.7) vs. 5.1 (3.1-8.1)) of OBSERVANT and OBSERVANT II patients were similar. At 1 year, patients of the OBSERVANT II study had a significantly lower risk of all-cause death (10.6% vs. 16.3%, Hazard Ratio (HR) 0.63 (95% Confidence Interval (CI) 0.52-0.76)) and rehospitalization for heart failure (HF) (14.3% vs. 19.5%, Sub-distribution HR 0.71 (95%CI 0.60-0.84)), whereas rates of stroke (3.1% vs. 3.6%) and permanent pacemaker implantation (PPI) (16.6% vs. 18.0%) were comparable between study groups. CONCLUSIONS: Age and risk profile among patients undergoing TAVI in Italy remained substantially unchanged between the 2010-2012 and 2016-2018 time periods. After adjustment, patients undergoing TAVI in the most recent era had lower risk of all-cause death and rehospitalization for HF at 1 year, whereas rates of stroke and PPI did not differ significantly.

Left atrial appendage closure with Amplatzer cardiac plug in atrial fibrillation: initial European experience.

BACKGROUND: In most patients with atrial fibrillation (AF) and stroke, there is thrombotic embolization from the left atrial appendage (LAA). Percutaneous closure of the LAA is a novel alternative for the treatment of patients with AF at a high risk of stroke, in whom long-term anticoagulation therapy is not possible or not desired. This study details the initial experience with the Amplatzer Cardiac Plug (ACP) in humans. METHODS: Investigator-initiated retrospective preregistry data collection to evaluate procedural feasibility and safety up to 24 hr after implantation of the ACP, a nitinol device designed for percutaneous trans-septal implantation in LAA of patients with paroxysmal, permanent, or persistent AF. RESULTS: In 137 of 143 patients, LAA occlusion was attempted, and successfully performed in 132 (96%). There were serious complications in 10 (7.0%) patients (three patients with ischemic stroke; two patients experienced device embolization, both percutaneously recaptured; and five patients with clinically significant pericardial effusions). Minor complications were insignificant pericardial effusions in four, transient myocardial ischemia in two, and loss of the implant in the venous system in one patient. CONCLUSION: The implantation of the ACP device is a feasible method for percutaneous occlusion of the LAA.

The challenge of integrated echocardiographic approach in percutaneous closure of paravalvular leak.

Paravalvular leak after prosthetic mitral valve surgery may lead to symptomatic mitral regurgitation and hemolytic anemia requiring reoperation. Percutaneous closure of paravalvular leaks is a relatively recent technique still considered a challenging procedure burdened by possible complications, to be offered only to poor redo surgical candidate patients. Multimodality imaging is advocated to plan and guide the procedure, to minimize the risk of complications. We report on a case of dehisced prosthetic mitral valve in which transthoracic real time three-dimensional echocardiography was used to locate the dehiscence area and characterize mitral paraprosthesis leak, whereas intracardiac echocardiography was used to guide and monitor the percutaneous closure procedure.

[Transcatheter closure of ventricular septal defect: how and when?] / Chiusura percutanea di difetto interventricolare post-infartuale: come e quando?

Ventricular septal defect (VSD) is a rare but clinically severe complication of acute myocardial infarction. Although cardiac surgery is the gold standard to correct post-infarction VSD, transcatheter closure represents an effective therapeutic alternative in selected cases. However, the correct timing for VSD correction is a matter of debate. Herein, we report the case of a patient who underwent transcatheter closure of post-infarction VSD, focusing the discussion on the pros and cons of an early VSD correction.

[First results from the OBSERVANT II study: clinical characteristics of patients with aortic stenosis undergoing transcatheter treatment with new generation devices]. / Primi risultati dello studio OBSERVANT II: caratteristiche cliniche dei pazienti con stenosi aortica sottoposti a procedure transcatetere con dispositivi di nuova generazione.

BACKGROUND: The OBSERVANT study evaluated the medium and long-term outcomes in patients undergoing transcatheter aortic valve implantation (TAVI) versus surgical aortic valve replacement obtaining comparative effectiveness results at least for the first-generation devices. The OBSERVANT II study enrolled a new series of TAVI procedures to evaluate whether the use of new-generation devices has modified outcome differences recorded in the OBSERVANT study. The aim of this paper is to describe the clinical characteristics of the OBSERVANT II population and compare them with those of the OBSERVANT population. METHODS: OBSERVANT II is a prospective multicenter observational study, which enrolled patients with severe aortic stenosis, who underwent a TAVI procedure in 30 Italian centers from December 2016 to September 2018. Clinical, anatomical and procedural information was recorded for each patient as well as procedure characteristics and any periprocedural outcomes. An administrative follow-up will allow to obtain information on medium and long-term outcomes. RESULTS: The enrolled population consists of 3001 patients with a mean age similar to that recorded in OBSERVANT (81.7 ± 6.3 vs 81.9 ± 6.2 years; p=0.336). OBSERVANT II patients show a lower prevalence of several morbid conditions than OBSERVANT patients (i.e. chronic obstructive pulmonary disease, coronary artery disease, peripheral arterial disease, etc.), though having very similar mean values of EuroSCORE II (7.2 ± 7.6% vs 7.4 ± 7.9%; p=0.558). According to three EuroSCORE II risk classes (≤3; 3-7; ≥7), the in-hospital mortality rates for patients enrolled in the two studies are 1.0% vs 2.0% (p≤0.000), 1.4% vs 4.1% (p<0.000) and 2.4% vs 7.7% (p<0.000), respectively. CONCLUSIONS: The first results of the OBSERVANT II study show that patients undergoing TAVI with new-generation devices are elderly, have a lower risk profile than patients enrolled in the OBSERVANT study but comparable mean values of EuroSCORE II. The in-hospital mortality rate for patients enrolled in the OBSERVANT II study is lower than that recorded in the OBSERVANT study across all the EuroSCORE II risk classes.

Early and late outcomes after transcatheter versus surgical aortic valve replacement in obese patients.

INTRODUCTION: Data on the early and late outcome following transcatheter aortic valve implantation (TAVI) and surgical aortic valve replacement (SAVR) in obese patients are limited. We investigated whether TAVI may be superior to SAVR in obese patients. MATERIAL AND METHODS: Obese patients (body mass index ≥ 30 kg/m2) who underwent either SAVR or TAVI were identified from the nationwide OBSERVANT registry, and their in-hospital and long-term outcomes were analysed. Propensity score matching was employed to identify two cohorts with similar baseline characteristics. RESULTS: The propensity score matching provided 142 pairs balanced in terms of baseline risk factors. In-hospital and 30-day mortality did not differ between SAVR and TAVI obese patients (4.6% vs. 3.3%, p = 0.56, and 5.2% vs. 3.2%, p = 0.41, respectively). Obese SAVR patients experienced a higher rate of renal failure (12.4% vs. 3.6%, p = 0.0105) and blood transfusion requirement (60.3% vs. 25.7%, p < 0.0001) in comparison with TAVI patients. A higher rate of permanent pacemaker implantation (14.4% vs. 3.6%, p = 0.0018), and major vascular injuries (7.4% vs. 0%, p = 0.0044) occurred in the TAVI group. Five-year survival was higher in the SAVR group compared to the TAVI patient cohort (p = 0.0046), with survival estimates at 1, 3 and 5 years of 88.0%, 80.3%, 71.8% for patients undergoing SAVR, and 85.2%, 69.0%, 52.8% for those subjected to TAVI procedures. CONCLUSIONS: In obese patients, both SAVR and TAVI are valid treatment options, although in the long term SAVR exhibited higher survival rates.