Chronic thromboembolic pulmonary hypertension risk score evaluation and validation (CTEPH SOLUTION): proposal of a study protocol aimed to realize a validated risk score for early diagnosis.

BACKGROUND: Chronic thromboembolic pulmonary hypertension (CTEPH) is the most serious long-term complication of acute pulmonary embolism (PE) though it is the only potentially reversible form of pulmonary hypertension (PH). Its incidence is mainly limited to the first 2 years following the embolic event, however it is often underdiagnosed or misdiagnosed. METHODS: This is a multicenter observational cross-sectional and prospective study. Patients with a prior diagnosis of PE will be enrolled and undergo baseline evaluation for prevalent PH detection through a clinical examination and an echocardiogram as first screening exam. All cases of intermediate-high echocardiographic probability of PH will be confirmed by right heart catheterization and then identified as CTEPH through appropriate imaging and functional examinations in order to exclude other causes of PH. A CTEPH Risk Score will be created using retrospective data from this prevalent cohort of patients and will be then validated on an incident cohort of patients with acute PE. RESULTS: One thousand retrospective and 218 prospective patients are expected to be enrolled and the study is expected to be completed by the end of 2021. Up to now 841 patients (620 retrospective and 221 prospective) have been enrolled. CONCLUSIONS: This study is the first large prospective study for the prediction of CTEPH development in patients with PE. It aims to create a comprehensive scoring tool that includes echocardiographic data which may allow early detection of CTEPH and the application of targeted follow-up screening programs in patients with PE.

Incidence of Long-Term Structural Valve Dysfunction and Bioprosthetic Valve Failure After Transcatheter Aortic Valve Replacement.

Background Long-term data on durability of currently available transcatheter heart valves are sparse. We sought to assess the incidence of long-term (8-year) structural valve dysfunction and bioprosthetic valve failure in a cohort of patients with transcatheter aortic valve replacement ( TAVR ) who reached at least 5-year follow-up. Methods and Results Consecutive patients with at least 5-year follow-up available undergoing TAVR from June 4, 2007 to March 30, 2012 were included. Structural valve dysfunction and bioprosthetic valve failure were defined according to newly standardized European Association of Percutaneous Cardiovascular Interventions/ European Society of Cardiology/European Association for Cardio-Thoracic Surgery criteria and reported as cumulative incidence function to account for the competing risk of death. A total of 288 consecutive patients with a mean age of 80.7±5.3 years and with a mean Society of Thoracic Surgery mortality score of 8.1±5.1% were analyzed. Survival rate at 8 years was 29.8%. Mean pressure gradients decreased from 53.3±15.9 mm Hg (pre- TAVR ) to 10.5±4.5 mm Hg (in-hospital post- TAVR ) ( P<0.001). There was a small, not significant, increase in the transaortic gradient throughout follow-up. Bioprosthetic valve failure was observed in a total of 11 patients (8-year cumulative incidence function: 4.51%; 95% confidence interval , 1.95%-8.76%). Severe and moderate structural valve dysfunctions were reported in 7 patients (8-year cumulative incidence function: 2.39%; 95% confidence interval, 0.77%-5.71%) and 13 patients (8-year cumulative incidence function: 5.87%; 95% confidence interval , 3.06%-9.96%), respectively. Aortic valve reintervention (redo TAVR ) was successfully performed in 2 patients (0.7%) presenting with symptomatic severe restenosis and intraprosthetic regurgitation subsequent to endocarditis. Conclusions In an aged population of patients with symptomatic severe aortic stenosis treated with first-generation bioprostheses, TAVR was associated with a survival rate of 30% but low rates of bioprosthetic valve failure and structural valve dysfunction at 8 years.

Optimized Screening of Coronary Artery Disease With Invasive Coronary Angiography and Ad Hoc Percutaneous Coronary Intervention During Transcatheter Aortic Valve Replacement.

BACKGROUND: We sought to describe an optimized approach to coronary artery disease (CAD) screening and management in patients undergoing transcatheter aortic valve replacement (TAVR). METHODS AND RESULTS: When invasive coronary angiography showed CAD, the treatment strategy and completeness of revascularization was determined based on coronary anatomy. TAVR was performed in the same setting if percutaneous coronary intervention (PCI) was uncomplicated; otherwise TAVR was postponed. A total of 604 patients undergoing CAD screening at the time of TAVR procedure were prospectively included in this study. Severe CAD was found in 136 patients (22.5%). Among patients with severe CAD, 53 patients (8.8%) underwent uncomplicated PCI. After PCI, TAVR was postponed in 2 patients (0.3%). In 83 patients (13.8%), coronary angiography showed severe CAD that was left untreated. After TAVR, all-cause and cardiovascular 30-day mortality rates were 2.4% and 1.4%, respectively. Disabling stroke, myocardial infarction, and life-threatening bleeding occurred in 0.5%, 0.8%, and 4.0% of patients, respectively. Acute kidney injury II or III rate was 3.3%. At 2 years, all-cause mortality rate was 14.1%. Disabling stroke and myocardial infarction occurred in 2.5% and 1.8% of patients, respectively. Patients undergoing TAVR and PCI in the same session had similar rate of the composite of death, disabling stroke, and myocardial infarction when compared with patients without CAD, and patients with severe CAD left untreated (TAVR+PCI: 10.4%; severe CAD left untreated: 15.4%; no-CAD: 14.8%; P=0.765). CONCLUSIONS: In patients undergoing TAVR, screening of CAD with invasive coronary angiography and ad hoc PCI during TAVR is feasible and was not associated with increased periprocedural risks. PCI followed by TAVR in the same session had similar outcomes than TAVR in which PCI was not performed.

Four-year durability of clinical and haemodynamic outcomes of transcatheter aortic valve implantation with the self-expanding CoreValve.

AIMS: Long-term data on the durability of currently available transcatheter heart valves are limited. We sought to assess four-year clinical and echocardiographic outcomes in patients undergoing transcatheter aortic valve implantation (TAVI) with the CoreValve prosthesis. METHODS AND RESULTS: Between June 2007 and February 2014, 450 consecutive patients with symptomatic severe aortic stenosis underwent TAVI in our institution. For the purposes of this study, we included only those patients undergoing successful TAVI with the CoreValve prosthesis who had a minimum follow-up of four years (n=125). Survival rates at one, two, three and four years were 83.2, 76.8, 73.6 and 66.3%, respectively. Aortic regurgitation was a common finding after the procedure, especially due to paravalvular regurgitation (PVR), which was observed in the majority of patients (71.5%), mostly mild (52.0%). Progression from mild acute PVR to moderate PVR at four-year follow-up was reported in three patients. No cases of severe PVR were observed. Prosthetic valve failure was reported in four patients (3.2%). CONCLUSIONS: Our study demonstrates that favourable outcomes after successful TAVI are associated with sustained clinical and functional cardiovascular benefits up to four-year follow-up. Signs of moderate prosthetic valve failure are present only in a small percentage of patients.

Acute Kidney Injury With the RenalGuard System in Patients Undergoing Transcatheter Aortic Valve Replacement: The PROTECT-TAVI Trial (PROphylactic effecT of furosEmide-induCed diuresis with matched isotonic intravenous hydraTion in Transcatheter Aortic Valve Implantation).

OBJECTIVES: The purpose of this study was to investigate the effect of the RenalGuard System (PLC Medical Systems, Milford, Massachusetts) on prevention of acute kidney injury (AKI) in patients undergoing transcatheter aortic valve replacement (TAVR). BACKGROUND: TAVR is associated with varying degrees of post-procedural AKI. The RenalGuard System is a dedicated device designed for contrast-induced AKI prevention. Whether this device is also effective in patients with severe aortic stenosis undergoing TAVR is unexplored. METHODS: The present is an investigator-driven, single-center, prospective, open-label, registry-based randomized study that used the TAVR institutional registry of the Ferrarotto Hospital in Catania, Italy, as the platform for randomization, data collection, and follow-up assessment. A total of 112 consecutive patients undergoing TAVR were randomly assigned to hydration with normal saline solution controlled by the RenalGuard system and furosemide (RenalGuard group) or normal saline solution (control group). The primary endpoint was the incidence of Valve Academic Research Consortium-defined AKI in the first 72 h after the procedure. RESULTS: The AKI rate was lower in the RenalGuard group than in the control group (n = 3 [5.4%] vs. n =14 [25.0%], respectively, p = 0.014). The majority of patients (5.4% vs. 23.2%) developed a mild AKI (stage 1); severe damage (stage 3) occurred only in 1 patient in the control group (0.0% vs. 1.8%). No case of in-hospital renal failure requiring dialysis was reported. No significant differences in terms of mortality, cerebrovascular events, bleeding, and hospitalization for heart failure were noted in both groups at 30 days. CONCLUSIONS: Furosemide-induced diuresis with matched isotonic intravenous hydration using the RenalGuard system is an effective therapeutic tool to reduce the occurrence of AKI in patients undergoing TAVR.

Early discharge after transfemoral transcatheter aortic valve implantation.

BACKGROUND: The aim of this study was to assess the feasibility and the safety of early discharge (within 72 h) after transfemoral transcatheter aortic valve implantation (TAVI) and to identify baseline features and/or peri-procedural variables, which may affect post-TAVI length-of-stay (LoS) duration. METHODS AND RESULTS: Patients discharged within 72 h of TAVI (early discharge group) were compared with consecutive patients discharged after 3 days (late discharge group). Propensity-matched cohorts of patients with a 2:1 ratio were created to better control confounding bias. Among 465 patients, 107 (23.0%) were discharged within 3 days of the procedure. Multivariable regression analysis of unmatched patients demonstrated that baseline New York Heart Association (NYHA) class IV (OR: 0.22, 95% CI 0.05 to 0.96; p=0.045) and any bleeding (OR: 0.31, 95% CI 0.74 to 0.92; p=0.031) were less likely to be associated with early discharge after TAVI. Conversely, the year of procedure (OR: 1.66, 95% CI 1.25 to 2.20; p<0.001) and the presence of a permanent pacemaker (PPM) before TAVI (OR: 2.80, 95% CI 1.36 to 5.75; p=0.005) were associated with a higher probability of early discharge. In matched populations, patients in the early discharge group reported lower incidence of in-hospital bleeding (7.9% vs 19.4%, p=0.014), major vascular complications (2.3% vs 9.1%, p=0.038) and PPM implantation (7.9% vs18.5%, p=0.021), whereas after discharge, at 30-day, no significant differences were reported between groups in terms of death (2.2% vs 1.7%, p=0.540), bleeding (0.0% vs 1.1%, p=0.444), PPM implantation (1.1% vs 0.0%, p=0.333) and re-hospitalisation (1.1% vs 1.1%, p=1.000). CONCLUSIONS: Early discharge (within 72 h) after transfemoral TAVI is feasible and does not seem to jeopardise the early safety of the procedure, when performed in a subset of patients selected by clinical judgement. Patients undergoing TAVI in unstable haemodynamic compensation and patients experiencing bleeding after the procedure demonstrated to be poorly suitable to this approach, whereas increasing experience in post-TAVI management was associated with a reduction of LoS.

Usefulness of contrast injection during balloon aortic valvuloplasty before transcatheter aortic valve replacement: a pilot study.

AIMS: To describe a technique of simultaneous aortography and balloon aortic valvuloplasty (BAV) before transcatheter aortic valve replacement (TAVR), and to show how this technique affected TAVR prosthesis selection and procedural outcomes. METHODS AND RESULTS: One hundred and eleven patients underwent simultaneous contrast injection during valvuloplasty pre-TAVR to confirm the indication for prosthesis size provided by non-invasive imaging studies. A successful injection was achieved in 95 patients (85.5%). No events occurred during simultaneous BAV and contrast injection. In 12 (10.8%) patients the prosthesis size implanted was different from the recommendations provided by the non-invasive imaging examinations. In nine of these cases (75.0%) it was decided to implant a larger prosthesis than that originally suggested, in the remaining three cases (25.0%) a smaller valve was implanted. Device success in this particular subset of patients was 100%. Overall device success was 92.8%. Post-procedural moderate paravalvular regurgitation was reported in 5.4% of patients. CONCLUSIONS: In patients with severe aortic valve stenosis, a technique of simultaneous aortography and balloon valvuloplasty as an adjunct to non-invasive imaging modalities for transcatheter prosthesis selection is feasible, and leads to a change in TAVR strategy in a modest number of patients. Larger studies are necessary to confirm these findings, and to assess whether this method is capable of enhancing the safety of the TAVR procedure.