Risk Score for Prediction of Dialysis After Transcatheter Aortic Valve Replacement.

BACKGROUND: Dialysis is a rare but serious complication after transcatheter aortic valve replacement. We analyzed the large multicenter TRITAVI (transfusion requirements in transcatheter aortic valve implantation) registry in order to develop and validate a clinical score assessing this risk. METHODS AND RESULTS: A total of 10 071 consecutive patients were enrolled in 19 European centers. Patients were randomly assigned (2:1) to a derivation and validation cohort. Two scores were developed, 1 including only preprocedural variables (TRITAVIpre) and 1 also including procedural variables (TRITAVIpost). In the 6714 patients of the derivation cohort (age 82±6 years, 48% men), preprocedural factors independently associated with dialysis and included in the TRITAVIpre score were male sex, diabetes, prior coronary artery bypass graft, anemia, nonfemoral access, and creatinine clearance <30 mL/min per m2. Additional independent predictors among procedural features were volume of contrast, need for transfusion, and major vascular complications. Both scores showed a good discrimination power for identifying risk for dialysis with C-statistic 0.78 for TRITAVIpre and C-statistic 0.88 for TRITAVIpost score. Need for dialysis increased from the lowest to the highest of 3 risk score groups (from 0.3% to 3.9% for TRITAVIpre score and from 0.1% to 6.2% for TRITAVIpost score). Analysis of the 3357 patients of the validation cohort (age 82±7 years, 48% men) confirmed the good discrimination power of both scores (C-statistic 0.80 for TRITAVIpre and 0.81 for TRITAVIpost score). Need for dialysis was associated with a significant increase in 1-year mortality (from 6.9% to 54.4%; P=0.0001). CONCLUSIONS: A simple preprocedural clinical score can help predict the risk of dialysis after transcatheter aortic valve replacement.

[Single-center retrospective observational study on predictors of residual mitral regurgitation 1 year after MitraClip® implantation]. / Studio osservazionale retrospettivo monocentrico sui predittori di insufficienza mitralica residua a 1 anno dall'impianto di MitraClip®.

BACKGROUND: The extent of residual mitral regurgitation (MR) (1+ vs ≥2+) has a notable impact on the outcome of MitraClip (MC) repair of significant functional MR. In this retrospective single-center study, we evaluated the predictors of MI ≥2+ at 1 year in one of our case series. METHODS: Overall, 58 patients with moderate severe functional MR underwent MC implantation; of these, 48 patients had instrumental clinical follow-up for 1 year. RESULTS: At 1 year, 10 patients died (mortality 17.2%). In the remaining 48 patients, the incidence of rehospitalization was 8.3%, and the incidence of MR grade 1+ and ≥2+ was 54.1% (n = 26) and 45.9% (n = 22), respectively. In patients with MR ≥2+, clinical and instrumental outcomes were worse than in patients with MR 1+. The height of the posterior leaflet and the extent of immediate postprocedural MR were independent predictors of MR ≥2+. CONCLUSIONS: Percutaneous repair with MC of moderate/severe functional MR has favorable 1-year outcomes in terms of mortality and rehospitalizations. The best results are achieved in patients with residual MR 1+. Echocardiographic parameters are independent predictors of residual MR ≥2+.

Dipeptidyl Amino-Peptidase 3 (DPP3) as an Early Marker of Severity in a Patient Population with Cardiogenic Shock.

Dipeptidyl amino-peptidase 3 (DPP3) is an aminopeptidase that is released into circulation upon cell death. DPP3 is involved in the degradation of angiotensins, enkephalines, and endomorphines. It has been shown that circulating DPP3 (cDPP3) plasma concentration increases in cardiogenic shock (CS) patients and correlates with high mortality risk. Cardiogenic shock is a life-threatening syndrome associated with organ hypoperfusion. One of the common causes of CS is acute myocardial infarction (AMI). This study aimed to investigate if cDPP3 levels are associated with CS severity and the need for ventilation in patients suffering from CS. Fifteen patients with CS were included in this study. Six patients were invasively ventilated. The values of cDPP3 were higher in ventilated patients than in non-ventilated patients at admission, 3 h, and 24 h after admission in the intensive care unit. Patients with pulmonary hypertension at admission also showed high cDPP3 values at all time points. Furthermore, high cDPP3 levels were associated with reduced stroke volume. Our results suggest that cDPP3 could predict CS progression and guide therapy escalation.

Vitamin D and cardiovascular disease risk. A literature overview.

BACKGROUND: Atherosclerosis and cerebro and cardiovascular disease associated represent the major cause of morbidity and mortality worldwide. Recently, vitamin D deficiency has been considered a new potential risk factor of these conditions. METHODS AND RESULTS: In this reviw we briefly describe the biological role of vitamin D, analyze the pathophysiological associations between cardiovascular disease and vitamin D, summarize and synthesize the evidence from literature about the association between vitamin D and cardiovascular disease. RESULTS: Vit D is an essential vitamin for bone metabolism and homeostasis. The maintenance of optimal blood levels contributes to the correct homeostasis by influencing different metabolic processes, including those underlying cardiovascular diseases. However, the evidence does not support vitamin D routine administration for the prevention and treatment of cardiovascular disease and intake to achieve specific cardiovascular effects. Evidence shows that maintaining optimal levels of vitamin D, ensures cardiovascular protection.

Clinical and Hemodynamic Outcomes of Rapid-Deployment Aortic Bioprostheses.

Aim of this retrospective, multicenter study was to evaluate early and mid-term clinical and hemodynamic results of patients who underwent surgical aortic valve replacement (SAVR) with Intuity rapid-deployment bioprostheses (RDB) (Edwards Lifesciences, Irvine, CA). We analyzed data from the Italian Registry of Intuity Valve (INTU-ITA registry) that is a national, real-world and independent from the industry registry. Preoperative variables were defined according to EuroSCORE and postoperative outcomes according to Valve Academic Research Consortium (VARC). Survival distribution was evaluated using the Kaplan-Meier approach. A Cox-Proportional Hazard Model was employed to assess the effect of the covariates on patients' survival. The registry included 1687 patients from 23 centers (June 2012-September 2019). Aortic cross clamp time for isolated SAVR was 55 minutes (IQR: 45-70 minute). Postoperative pace-maker rate was 6.3%. At discharge transaortic peak and mean gradients were: 18 mm Hg (IQR: 14-23 mm Hg) and 10 mmHg (IQR: 8-13 mm Hg), respectively. Indexed effective orifice area was 1.10 cm2/m2 (IQR: 0.91-1.31 cm2/m2) and the incidence of severe patient-prosthesis mismatch was 0.6%. Hemodynamic data for all valve sizes remained stable during follow-up. Thirty-day overall mortality was 1.8% (30 patients), and at follow-up it was 5.3% (89 patients). Kaplan-Meier overall survival was 95.5% (94.3-96.7%); 90.7% (88.3-93.1%); 86.4% (82.6-90.4%) at 1, 3, and 5 years, respectively. Serum creatinine (HR: 1.36; 95%CI: 1.04-1.81; p = 0.0397) and cross-clamp time (HR: 1.01; 95%CI: 1.002-1.017; p = 0.0077) were identified as independent predictors of mortality. According to our data from the INTU-ITA registry, SAVR with RDB provides good early clinical and hemodynamic results that are confirmed at follow-up.

Proximal versus distal protection: dissecting clinical trials.

Carotid artery stenting (CAS) is a valid alternative to conventional carotid endarterectomy for treatment of carotid artery stenosis. Distal embolization of atherosclerotic debris causing cerebrovascular accidents during CAS has been the most significant concern limiting widespread application of CAS technology. A variety of embolic protection devices (EPDs) with different mechanism of action, have been designed to minimize the risk of major embolization causing stroke and their use is recommended by current guidelines. Two general types of EPDs are available: proximal protection devices (PPDs) and distal protection devices (DPDs). However, there is no convincing clinical evidence of the clinical superiority of one device over another. This review will examine the different types of available devices and also innovative devices and techniques, including strengths and weaknesses of each, and present the available evidence and rationale for their routine use during CAS.

Mini-thoracotomy in redo mitral valve surgery: safety and efficacy of a standardized procedure.

BACKGROUND: Re-operative mitral valve surgery is sometimes burdened by a greater technical difficulty and a higher complications rate than the first operation. Minimally invasive cardiac surgery has become routine, and it could significantly reduce the surgical risk in redo surgery. The objective of our retrospective observational study is to assess the results of cardiac reoperations in patients with mitral valve disease approached trough a 5-7 cm right mini-thoracotomy. METHODS: From February 2017 to December 2019, 65 patients underwent re-operative mitral valve surgery in our institution. Cardiopulmonary bypass (CPB) was started by cannulation of the femoral and jugular vein and femoral artery or alternatively right axillary artery. Patients enrolled had a mean age of 66.6±11.5 years. Patients were divided into three groups based on the procedure adopted: external aortic cross-clamp (EAC), EndoAortic balloon occlusion (EABO) and ventricular fibrillation (VF). Major complications were evaluated and compared with a propensity matched population of patients undergoing elective isolated mitral valve surgery via right minithoracotomy (MVS). RESULTS: The average time between last operation and reoperation was 7.1±3.4 years. Fourteen patients (21%) underwent mitral valve repair and 51 patients (78%) underwent mitral valve replacement; 9 patients (14%) received tricuspid valve surgery. There was no statistically significant difference in CPB time between the groups. Seven patients (11%) had a postoperative renal failure, 5 patients (8%) underwent surgical reopening for bleeding; incidence of post-operative stroke and pace-maker implantation was 3% for both. No deaths were registered during in-hospital stay and at 30-days echocardiographic control all patients respect the criterions of device success according with MVARC. Propensity matched patients of group redo had a longer CPB time (100.8±42.7 versus 72.8±16.7 min, P<0.001) and cross-clamp time (71.9±30.7 versus 59±10.7 min, P<0.001) respect to first operation mitral valve surgery patients. CONCLUSIONS: Minimally invasive mitral valve redo surgery is a safe procedure. Less invasive techniques in redo surgery could minimize morbidity and mortality without prolonging the duration of CPB.

Minimally Invasive vs Conventional Aortic Valve Replacement With Rapid-Deployment Bioprostheses.

BACKGROUND: The aim of this multicenter retrospective study was to compare early and midterm clinical and hemodynamic results of aortic valve replacement with rapid-deployment bioprostheses performed through conventional full-sternotomy vs mini-sternotomy. METHODS: Data from the Italian multicenter registry of aortic valve replacement with rapid-deployment bioprostheses (INTU-ITA registry) were analyzed. Patients were divided into 2 groups: full sternotomy (FS) and ministernotomy (MS). Primary endpoint was the comparison of early and midterm mortality. Secondary endpoints were: comparison of intraoperative variables, complications, and hemodynamic performance. A propensity score weighting approach was used for data analysis. RESULTS: A total of 1057 patients were analyzed: 435 (41.2%) and 622 (58.8%) in group FS and MS, respectively. Thirty-day mortality was 1.6% and 0.6% in FS and MS groups, respectively (P = .074). cardiopulmonary bypass time was 78.5 minutes and 83 minutes in FS and MS groups, respectively (P = .414). In the overall cohort, the incidence of intraoperative complications and of device success was 3.8% (40 patients) and 95.9% (1014 patients), respectively, with no significant differences between groups. Survival at 1, 3, and 5 years was 94.1%, 98.1%, 88.5% and 91.8%, 85.2%, and 84.8% in FS and MS groups, respectively (P = .412). The 2 groups showed similar postoperative gradients (median mean gradient, FS: 10.0 mm Hg, MS: 11.0 mm Hg; P = .170) and also similar incidence of patient-prosthesis mismatch (FS: 7%, MS: 6.4%, P = .647). CONCLUSIONS: According to our data, rapid-deployment bioprostheses allow the performance of minimally invasive aortic valve replacement with similar surgical times and similar clinical and hemodynamic outcomes to conventional surgery and should be considered the first choice in these procedures.

Anomalous coronary sinus: A predictor of challenging redo mitral surgery.

In the spectrum of congenital heart diseases, anomalies involving the venous coronary sinus have received relatively little attention, although they are often associated with major congenital defects, such as atrioventricular septal defects. In cases of mitral surgery in patients with these conditions, it is mandatory to keep the problem in mind and to respect the coronary sinus when approaching the left atrium and the mitral valve.

Early and Mid-Term Results of Rapid Deployment Valves: The Intuity Italian Registry (INTU-ITA).

BACKGROUND: Rapid deployment bioprostheses (RDBs) have been recently introduced into clinical practice for the treatment of severe aortic valve stenosis. The aim of this retrospective multicenter study was to assess early and mid-term clinical and hemodynamic outcomes of patients undergoing RDB implantation. METHODS: Data from a national registry that included patients who underwent isolated or combined aortic valve replacement with RDB in Italy were analyzed. Definitions of the European System for Cardiac Operative Risk Evaluation were used for preoperative variables and updated definitions from the Valve Academic Research Consortium were used for postoperative outcomes assessment. Univariable and multivariable analyses were performed to identify independent predictors of mortality. Follow-up was performed with clinical and echocardiographic examinations at each study site and, if this was not possible, through telephonic interviews. The Kaplan-Meier method was used for survival analysis. RESULTS: A total of 902 patients (December 2012 through November 2017) from 20 national centers were included in the registry. Device success was 95.9%, and 30-day all-cause mortality was 2.8%. Postoperative pacemaker implantation was needed in 63 patients (6.9%). At discharge, peak and mean transaortic gradients were 19 ± 7 mm Hg and 11 ± 4 mm Hg, respectively. Mild and moderate aortic regurgitation were found in 71 patients (8.2%) and in 10 patients (1.2%), respectively. Median follow-up time was 357 days (interquartile range: 103 to 638 days). Survival at 4 years was 86% ± 1%. Preoperative conduction disturbances and history of previous myocardial infarction were independently associated with mortality. CONCLUSIONS: Aortic RDBs provide good early and mid-term clinical and hemodynamic outcomes. These devices may be considered as a reasonable alternative to conventional bioprostheses, especially in minimally invasive and combined operations.

Transapical aortic valve replacement is a safe option in patients with poor left ventricular ejection fraction: results from the Italian Transcatheter Balloon-Expandable Registry (ITER).

OBJECTIVES: The most commonly used accesses for transcatheter aortic valve implantation (TAVI) are the transfemoral (TF-TAVI) and the transapical (TA-TAVI) ones. There are concerns about TA-TAVI use in patients with reduced left ventricular ejection fraction (LVEF). The aim of this retrospective multicentre study was to compare the outcomes of TA-TAVI and TF-TAVI in patients with poor LVEF. METHODS: Patients with LVEF ≤35% were included in the analysis. Data were obtained from the Italian Transcatheter Balloon-Expandable Registry (ITER), which enrolled patients undergoing TAVI with the Sapien bioprosthesis in 33 national centres. Patients were divided into 2 groups according to the access: TA or TF. A multivariable logistic regression analysis was performed in order to evaluate whether the type of approach (TA and TF) has an impact on outcomes. RESULTS: Between 2007 and 2012, 1882 patients were enrolled in the Registry. LVEF ≤35% was found in 208 (11.1%) patients. TA-TAVI and TF-TAVI were performed in 69 (33.2%) and 139 (66.8%) patients, respectively. Overall 30-day mortality was 11.6% and 7.9% in TA and TF patients, respectively (P = 0.45). Overall Kaplan-Meier survival was significantly higher in the TF-TAVI group (log rank: P = 0.003). Age [odds ratio (OR) 1.066, P = 0.016], creatinine (OR: 2.301, P < 0.001), preoperative permanent pacemaker (OR: 4.662, P = 0.035) and TA approach (OR: 2.577, P = 0.006) were identified as independent predictors of overall mortality at follow-up. However, the TA approach resulted an independent variable of mortality only 3 years after TAVI. CONCLUSIONS: TAVI yields good results in patients with depressed LVEF. Age, preoperative creatinine and preoperative pacemaker are independently associated with mortality. The TA access is associated with mortality only after 3 years of follow-up, thus probably reflecting a worse general clinical status of these patients.

Early and Midterm Clinical and Hemodynamic Outcomes of Transcatheter Valve-in-Valve Implantation: Results From a Multicenter Experience.

BACKGROUND: Transcatheter valve-in-valve (VIV) implantation is an alternative option in inoperable or high-risk patients with prosthetic valve dysfunction. Aim of this retrospective multicenter study was to evaluate early and midterm clinical and hemodynamic outcomes of patients undergoing aortic (VIV-A) and mitral VIV (VIV-M). METHODS: We analyzed data of 66 procedures performed in 65 patients who underwent VIV procedures in the VIV-A and VIV-M position at 5 Italian institutions from January 2008 to May 2015. VIV-A and VIV-M were 44 (68%) and 22 (32%), respectively; 1 patient underwent combined mitroaortic VIV. Study devices were both balloon-expandable and self-expandable. Outcomes were defined according to the updated Valve Academic Research Consortium definitions. RESULTS: Overall all-cause 30-day mortality was 6% (4 patients), and it was 4.5% and 9% in VIV-A and VIV-M, respectively (2 patients in each group). Mean follow-up was 14 ± 14 months. Kaplan-Meier survival of the entire cohort at 1, 2, 3, and 4 years was 84.4% ± 4.9%, 80.5% ± 6%, 74.3 ± 8.1%, and 62% ± 13.2%, respectively. Age (hazard ratio: 1.1; 95% confidence interval: 1.0 to 1.3; p = 0.035) and diabetes (hazard ratio: 7.2, 95% confidence interval: 2.1 to 23.7; p = 0.001) were identified as independent predictors of mortality. Degenerated surgical aortic prostheses with an internal diameter (ID) less than 20 mm had significantly higher gradients if compared to prostheses with ID 21 to 23 mm and greater than 23 mm. After VIV-A, a severe stenosis (mean gradient greater than 35 mm Hg) was detected in 3 (6.8%) cases, all with ID less than 20 mm. CONCLUSIONS: VIV provides good early and midterm results in high-risk or inoperable patients with mitral or aortic bioprosthesis dysfunction. Age and diabetes are independently associated with mortality. Size of bioprosthesis ID has a significant impact on postoperative gradients.

Combined venoarterial extracorporeal membrane oxygenation and transcatheter aortic valve implantation for the treatment of acute aortic prosthesis dysfunction in a high-risk patient.

We describe the case of a patient with acute bioprosthesis dysfunction in cardiogenic shock, in whom hemodynamic support was provided by venoarterial extracorporeal membrane oxygenation, and successfully treated by transcatheter aortic valve implantation.

Medium term outcomes of transapical aortic valve implantation: results from the Italian Registry of Trans-Apical Aortic Valve Implantation.

BACKGROUND: Transcatheter aortic valve implantation (TAVI) has been proposed as a therapeutic option for high-risk or inoperable patients with severe symptomatic aortic valve stenosis. The aim of this multicenter study was to assess early and medium term outcomes of transapical aortic valve implantation (TA-TAVI). METHODS: From April 2008 through June 2012, a total of 774 patients were enrolled in the Italian Registry of Trans-Apical Aortic Valve Implantation (I-TA). Twenty-one centers were included in the I-TA registry. Outcomes were also analyzed according to the impact of the learning curve (first 50% cases versus second 50% cases of each center) and of the procedural volume (high-volume versus low-volume centers). RESULTS: Mean age was 81.0±6.7 years, mean logistic European System for Cardiac Operative Risk Evaluation (EuroSCORE) I, EuroSCORE II, and The Society of Thoracic Surgeons risk score were 25.6%±16.3%, 9.4%±11.0%, and 10.6%±8.5%, respectively. Median follow-up was 12 months (range, 1 to 44). Thirty-day mortality was 9.9% (77 patients). Overall 1-, 2-, and 3-year survival was 81.7%±1.5%, 76.1%±1.9%, and 67.6%±3.2%, respectively. Thirty-day mortality of the first 50% patients of each center was higher when compared with the second half (p=0.04) but 3-year survival was not different (p=0.64). Conversely, 30-day mortality at low-volume centers versus high-volume centers was similar (p=0.22). At discharge, peak and mean transprosthetic gradients were 21.0±10.3 mm Hg and 10.2±4.1 mm Hg, respectively. These values remained stable 12 and 24 months after surgery. CONCLUSIONS: Transapical TAVI provides good results in terms of early and midterm clinical and hemodynamic outcomes. Thus it appears to be a safe and effective alternative treatment for patients who are inoperable or have high surgical risk.

Video-assisted minimally invasive mitral valve surgery: external aortic clamp versus endoclamp techniques.

OBJECTIVE: : Video-assisted minimally invasive mitral valve surgery can be performed through different approaches. The aim of the study was to report our early results and compare the external transthoracic aortic clamping with the endoaortic balloon occlusion techniques according to our experience. METHODS: : Between January 2000 and March 2010, 138 patients (103 women, aged 58.4 ± 10.2 years) underwent video-assisted mitral valve surgery through a right thoracotomy. Cardiopulmonary bypass was instituted by femoral arterial and bicaval cannulation with active venous drainage and normothermia; cardioplegic arrest achieved with intermittent blood cardioplegia. In group A (93 patients, 68 women, aged 58.8 ± 7.8 years, 72 MV replacement, 21 MV repair), aortic clamping was achieved using the external transthoracic aortic clamp. In group B (45 patients, 35 women, aged 58.1 ± 11.4 years, 33 MV replacement, 12 MV repair), aortic clamping was achieved with endoaortic balloon occlusion. RESULTS: : Intraoperative procedure-associated problems were experienced in one patient (0.7%) in group A (one conversion to sternotomy for pleural adhesions and bad exposure). At a mean follow-up of 36 ± 18 months, 135 patients (97.8%) were in New York Heart Association class I to II, with satisfactory echocardiographic follow-up. In group A, two patients had noncardiac-related deaths. No perioperative deaths were observed in both groups. There were four (2.8%) transient ischemic attacks and one (0.7%) peripheral ischemic event (group A) during the early postoperative period. Mitral valve repair patients had a 5-year freedom from reoperation of 100% in both groups. There was no significant difference between the two groups regarding preoperative variables, such as age, sex, New York Heart Association class, and left ventricular ejection fraction (P > 0.05). Postoperative levels of myocardial cytonecrosis enzymes (MB fraction, creatine kinase, and troponine I) as well as operative time, extracorporeal circulation, and aortic cross-clamping times or ventilation and intensive care unit times were not significantly different between the two groups (P > 0.05). More microembolic events were observed in group A than in group B (total 143.4 ± 30.6 per patient vs 78.9 ± 28.6 per patient) by means of continuous automated intraoperative transcranial Doppler evaluations (P < 0.05) applied to part of population. CONCLUSIONS: : Both techniques proved safe and comparable with low risk of morbidity and mortality. Patients undergoing endoclamp technique resulted to be less subject to embolism.

Heartmate II axial-flow left ventricular assist system: management, clinical review and personal experience.

OBJECTIVES: The excellent results with left ventricular assist devices (LVADs) have revolutionized the treatment options for end-stage heart failure. The use of pulsatile devices is associated with significant comorbidity and limited durability. The axial-flow HeartMate II LVAD represents the new generation of devices. The clinical use of this pump resulted in superior outcomes. We review the HeartMate II technology, management, clinical usage and our experience. METHODS: Between 3/2002 and 12/2008, 18 transplantable adult patients were supported on long-term HeartMate II LVAD at our institution (13 men, age 52 +/- 8.4 years, range: 31-64 years). Primary indications were: ischemic cardiomyopathy (CMP) (n = 13), idiopathic CMP (n = 5). All patients were in New York Heart Association (NYHA) Class IV heart failure. None of patients had prior open-heart surgery. Implantation via cannulation of the left ventricular apex and the ascending aorta was always elective. RESULTS: Mean support time was 217 +/- 212.3 days (range: 1-665 days). Early (30-day) mortality was 27.7% (five patients) with multiple organ failure and sepsis as main causes of death. Bleeding requiring reoperation occurred in six (33.3%) cases. Cerebral hemorrhage occurred in one patient. There were two driveline infections and no device failure. Twelve (66.6%) patients were successfully discharged home. Overall nine patients (50%) were transplanted and two patients are actually waiting for a suitable organ (n = 2 patients discharged home and n = 1 patient in hospital). At latest, follow-up survival rate after heart transplantation is 66.6% (six patients). CONCLUSION: Long-term HeartMate II LVAD provides good mid-term, long-term results. This new technology requires delicate management. Functional status and quality of life greatly improve in patients who survive the perioperative period.