The impact of transcatheter aortic valve implantation (TAVI) on mitral regurgitation - a single center study.

BACKGROUND: The coexistence of mitral regurgitation (MR) and severe aortic stenosis (AS) has been associated with worse outcomes in patients undergoing transcatheter aortic valve implantation (TAVI). Herein, the aim was to assess the etiology and degree of MR in an unselected TAVI population and investigate the impact of MR reduction at mid-term follow-up. METHODS: Patients subjected to TAVI as a treatment for severe AS in a single center were retrospectively analyzed. The primary endpoint was the MR reduction after TAVI. The secondary endpoint was all-cause mortality and heart failure hospitalization at a 3-year follow-up. RESULTS: Patients undergoing TAVI (n = 283) in the years 2017-2019 were screened for the presence of hemodynamically significant MR. Sixty-nine subjects (24.4%) with severe (16, 23.2%) and moderate (53, 76.8%) MR were included. The primary MR was predominant (39 subjects, 56.5%). The median age of the patients was 82 years. MR improved in 25 patients (36.2%, p < 0.001). Baseline severe MR was more prone to reduce (8 subjects, 50%) than moderate (17 subjects, 32.1%, p = 0.04). The primary MR improved in 14 patients (35.9%), while secondary in 11 patients (36.7%, p = 1). Patients showing MR reduction had lower mortality (8 vs. 29.55%, p = 0.047) and were less frequently hospitalized (20 vs. 45.45%, p = 0.03) at 3-year follow-up. CONCLUSIONS: Hemodynamically significant MR improves after TAVI regardless of its etiology. Moreover, MR reduction after TAVI is associated with better clinical outcomes.

Endovascular carotid revascularization under open-chest extracorporeal circulation combined with cardiac surgery in unstable patients at increased risk of carotid-related stroke: SIMultaneous urgent cardiac surgery and MicroNet-covered stent carotid revascularization in extreme-risk patients-SIMGUARD Study.

BACKGROUND: In patients at urgent need for cardiac surgery coexisting with increased-stroke-risk carotid stenosis, any staged intervention increases the risk of complications from the primarily unaddressed pathology. In this challenging cohort, we assessed safety and feasibility of endovascular carotid revascularization under open-chest extracorporeal circulation (ECC) combined with cardiac surgery (hybrid-room true simultaneous treatment). METHODS: Per-protocol (PP), after general anesthesia induction, chest-opening and ECC stand-by installation, carotid stenting (CAS) was performed (femoral/radial or direct carotid access) with ad-hoc/on-hand switch to ECC cardiac surgery. RESULTS: Over 78 months, 60 patients (70.7±6.9years, 85% male, all American Society of Anesthesiology grade IV) were enrolled. All were at increased carotid-related stroke risk (ipsilateral recent stroke/transient ischemick attack, asymptomatic cerebral infarct, increased-risk lesion morphology, bilateral severe stenosis). Majority of study procedures involved CAS+coronary bypass surgery or CAS+valve replacement±coronary bypass. 45 (75%) patients were PP- and 15 (25%) not-PP (NPP-) managed (context therapy). CAS was 100% neuroprotected (transient flow reversal-64.4%, filters-35.6%) and employed micronet-covered plaque-sequestrating stents with routine post-dilatation optimization/embedding. 4 deaths (6.7%) and 7 strokes (11.7%) occurred by 30-days. Despite CAS+surgery performed on aspirin and unfractionated heparin-only (delayed clopidogrel-loading), no thrombosis occurred in the stented arteries, and 30-days stent patency was 100%. NPP-management significantly increased the risk of death/ipsilateral stroke (OR 38.5; P<0.001) and death/any stroke (OR 12.3; P=0.002) by 30-days. CONCLUSIONS: In cardiac unstable patients at increased carotid-related stroke risk who require urgent cardiac surgery, simultaneous cardiac surgery and CAS with micronet-covered stent lesion sequestration is feasible and safe and shows efficacy in minimizing stroke risk. Larger-scale, multicentric evaluation is warranted. (SIMGUARD NCT04973579).

Patients with aortic valve disease and coronary artery disease can benefit from a hybrid approach combining aortic valve replacement through right minithoracotomy and percutaneous coronary intervention.

Introduction: Minimally invasive and hybrid procedures for patients with aortic valve pathology and coronary artery disease are innovative solutions. Aim: To report the results of hybrid aortic valve replacement through right anterior minithoracotomy (RT-AVR)/percutaneous coronary intervention (PCI) and conventional aortic valve replacement (AVR)/coronary artery bypass grafting (CABG) surgery for patients with aortic valve and coronary artery disease. Material and methods: Analysis of prospectively gathered data of 187 patients - 86 hybrid and 101 conventional procedures. For 21 patients, RT-AVR was followed by PCI during the same session, and for 65 patients RT-AVR was performed within 90 days of PCI. Results: Hospital mortality in the AVR/CABG and RT-AVR/PCI groups was 3.0% and 1.2%, respectively (p = 0.237). Complications occurred in 18.6% of patients in the RT-AVR/PCI group and 33.7% in the AVR/CABG group (p = 0.020). Two-stage RT-AVR/PCI was performed due to ACS (100%); one-stage was due to the intention to perform a minimally invasive procedure instead of AVR/CABG (71.4%) or due to replacing CABG with PCI because of a lack of vascular grafts for CABG (19.1%). In 38.5% of patients from the two-stage subgroup, antiplatelet therapy was stopped before RT-AVR, 32.3% of patients from the two-stage subgroup were on single, and 29.2% on dual antiplatelet therapy until RT-AVR, which had no influence on postoperative blood requirements or postoperative myocardial infarction (p = 0.410 and p = 0.077, respectively). Conclusions: The hybrid procedure presented in our series showed similar mortality and morbidity results and may be an alternative to conventional AVR and CABG through full sternotomy in selected patients.

Computed tomography guided tailored approach to transfemoral access in patients undergoing transcatheter aortic valve implantation.

BACKGROUND: Transfemoral approach (TFA) is the most common access route for transcatheter aortic valve implantation (TAVI). Percutaneous femoral access (PA) is preferred over the surgical approach (SA), however, may be associated with a higher risk of access site complications. Thus, we aimed to assess outcomes of computed tomography-guided tailored approach to percutaneous and surgical TFA in patients undergoing TAVI. METHODS: We evaluated data of 158 patients, who underwent TAVI via femoral route between January 2017 and December 2018. In the PA group, vascular closure was performed with the use of two percutaneous suture devices and an additional mechanical seal device. We compared complications rate and outcomes. RESULTS: Of the 158 patients (92%; mean age 79.6 years, 60.8% female), in 92 (61%) patients PA was performed and in 66 (39%) patients SA was used. Median (interquartile range) radiation exposure as well as contrast volume dose was higher in the PA group compared to the SA group 614.0 (410.0; 1104.0) mGy vs. 405 (240.5; 658.0) mGy (p < 0.001) and 150.0 (120.0; 180.7) mL vs. 130.0 (100.0; 160.0) mL (p = 0.04), respectively. Bleeding complications were similar in the PA group 11 (12.2%) compared to 5 (8.62%) in the SA group (p = 0.48). Median length of hospital stay was also similar in the PA and the SA group 6.00 (5.00; 8.00) days vs. 6.00 (4.00; 8.00) days, respectively (p = 0.31). CONCLUSIONS: Computed tomography-guided PA in TAVI may provide comparable procedural outcomes compared to the SA, despite a higher radiation dose and the use of contrast dye, while being less invasive.

Inpatient Cardiac Rehabilitation after Transcatheter Aortic Valve Replacement Is Associated with Improved Clinical Performance and Quality of Life.

Cardiac rehabilitation (CR) provides multifactorial support and intervention for cardiac patients and improves quality of life (QoL). We aimed to assess clinical performance and QoL changes in patients undergoing transcatheter aortic valve replacement (TAVR) scheduled directly to inpatient CR (CR group) and those who were discharged home (DH group). The following patient-related outcomes were recorded: 5 m walk time (5MWT), 6 min walk test (6MWT), handgrip strength (HGS) with dynamometer, Katz index of Independence of Activities in Daily Living (KI of ADL), Hospital Anxiety and Depression Scores (HADS) Score. Quality of life was evaluated with Kansas City Cardiomyopathy Questionnaire (KCCQ). Baseline data, 30-day and 6- and 12-month data were assessed. The CR group consisted of 52 patients and 53 were in the discharged home (DH group). When we compared outcomes between the groups, the 5MWT, 6MWT, HGS KI of ADL, and KCCQ were significantly better in the CR group at 30 days (p = 0.03, p = 0.01, p = 0.02, p = 0.048, respectively), and no difference was found in HADS scores. At 6 months, the effect of CR was sustained for 6MWT, HGS, KI of ADL, and KCCQ (p = 0.001, p = 0.001, p = 0.03, p = 0.003, respectively) but not for 5MWT. Interestingly, at 12 months, the CR group had better performance only in 6MWT and HGS compared with the DH group (p = 0.04, p = 0.03, respectively). We showed that inpatient CR is strongly associated with better clinical performance and QoL in patients undergoing TAVR. All patients may benefit from CR after TAVR. The most important aspect of inpatient CR after TAVR from the patient's perspective may be better performance in daily activities; however, performance was attenuated after 1 year.

Twelve-month outcomes of transapical transcatheter aortic valve implantation in patients with severe aortic valve stenosis.

INTRODUCTION: Transapical access (TA) transcatheter aortic valve implantation (TAVI) (TA-TAVI) represents one of the possible routes in patients with severe aortic stenosis (AS) who are not suitable for transfemoral access. AIM: To assess early- and mid-term clinical outcomes after TA-TAVI. MATERIAL AND METHODS: Patients with severe symptomatic AS undergoing TA-TAVI from November 2008 to December 2019 were enrolled. Clinical and procedural characteristics as well as clinical outcomes including all-cause mortality during 12-month follow-up were assessed. RESULTS: Sixty-one consecutive patients underwent TA-TAVI for native AS. Patients were elderly with median age of 80.0 (76.0-84.0) years; 55.7% were males. Median baseline EuroSCORE I and STS scores were 18.2% (11.6-27.7) and 4.8% (3.3-8.2), respectively. The procedural success rate was 96.7%. In-hospital, 30-day and 12-month mortality rates were 9.8%; 18.0% and 24.6%, respectively. The main periprocedural and in-hospital complications were bleeding complications (14.8%). The following factors were associated with 12-month mortality: previous cerebrovascular event (CVE), glomerular filtration rate (GFR), aortic valve area (AVA), right ventricular systolic pressure (RVSP) and serum level of N-terminal prohormone of brain natriuretic peptide (NT-proBNP) (RR for CVE 3.17, 95% confidence interval (CI): 1.15-8.76: p = 0.026; RR for AVA per 0.1 cm2 1.28, 95% CI: 1.03-1.55: p = 0.024; RR for GFR per 1 ml/min 0.96: 95% CI: 0.94-0.99: p = 0.007; RR for NT-proBNP per 1000 pg/ml 1.07: 95% CI: 1.01-1.17: p = 0.033; RR for RVSP per 1 mm Hg 1.07: 95% CI 1.02-1.16: p = 0.011). CONCLUSIONS: Transapical TAVI in high-risk patients provides good hemodynamic results with acceptable outcomes.

Early experience with the Thopaz+ chest drainage system - is this a new era in the management of post-cardiotomy bleeding?

INTRODUCTION: Monitoring postoperative drainage is a key aspect of patient assessment in the early postoperative period. Accurate assessment of drainage allows rapid diagnosis of postoperative bleeding, preventing excessive hemoglobin drop and cardiac tamponade. However, traditional methods of mediastinal drainage appear to be inaccurate and measurement can often be subjective, delaying the procedure. AIM: To demonstrate our initial experience with a digital chest drainage system that can be used to closely monitor postoperative drainage. MATERIAL AND METHODS: The Thopaz+ system allows manual regulation of negative pressure in the chest. The digital system analyzes the current and long-term values of the drainage, which facilitates therapeutic decisions. The advantage of the system is its mobility, without the need for built-in vacuums in the hospital wall. This allows early rehabilitation of the patient, which is crucial in the perioperative period. The Thopaz system has been used in 42 consecutive patients in all types of cardiac surgery procedures with good key results. RESULTS: We did not observe any complications with the system and the learning curve of the staff was very fast, both for the physicians and the operating room nurses, intensive care nurses and postoperative nurses. CONCLUSIONS: The first experiences with the Topaz+ system were very positive. The system brings a lot of safety and comfort to the cardiac surgical care we provide. These conclusions are consistent with data published in randomized trials.

Direct left ventricular wire pacing during transcatheter aortic valve implantation.

BACKGROUND: Rapid ventricular pacing is used during balloon aortic valvuloplasty, balloon­expandable transcatheter aortic valve implantation (TAVI), and for postdilatation. Right ventricular (RV) lead pacing has been regarded as a gold standard. Direct left ventricular (LV) wire pacing has recently been considered safe and effective in TAVI interventions. AIMS: This study aimed to analyze procedural outcomes of direct LV pacing compared with RV stimulation in unselected patients undergoing TAVI. METHODS: Direct LV wire pacing was provided via available preshaped guidewires and used only when no predictors of atrioventricular block were present. The primary study objective was the assessment of the efficacy of direct LV wire pacing. The secondary objectives included the evaluation of procedure duration and safety in comparison with the conventional method. A combined endpoint (major adverse cardiovascular event) was defined as the occurrence of death, stroke, venous puncture-related complications, and cardiac tamponade. RESULTS: In 2017 and 2018, 143 patients underwent transfemoral TAVI. Of these, 114 (79.7%) had self­ ­expandable valves implanted. Direct LV wire pacing was the dominant method of pacing (82 patients [57.3%]), and its efficacy reached 97.6%. The median (interquartile range) procedure time was shorter in the direct LV wire pacing group (80 [70-90] min vs 85 [70-95] min; P = 0.02). Major adverse cardiovascular events were more frequent in the RV lead pacing group (11.5% vs 4.9%), but no statistical significance was achieved (P = 0.13). CONCLUSIONS: Direct LV wire pacing during TAVI is a simple, reproducible, and safe technique, which provides reliable, sustained stimulation with a low complication rate and potential reduction of procedural time.

Applications of low-cost 3D printing in left atrial appendage closure using epicardial approaches - initial clinical experience.

INTRODUCTION: Left atrial appendage occlusion procedure (LAAO) became an alternative method for stroke prevention in atrial fibrillation (AF) patients with contraindication or intolerance for oral anticoagulation therapy. However, LAA anatomy is complex with several different types of LAA morphology. Therefore matching the correct size of a delivery device to LAA morphology is difficult. In such circumstances, the 3D-printed model of LAA closure may be useful for preoperative planning which increases the efficacy of LAAO procedure. MATERIAL AND METHODS: We report as a first 2 cases of LAA occlusion procedure using 2 different systems: thoracoscopic AtriClip and the LARIAT device in which a 3D printed LAA model was used in preoperative planning. RESULTS: In the first patient, preoperative measurements of 3D LAA model were performed using a dedicated selection guide for AtriClip device were comparable with the intraoperative examination. Left atrial appendage was closed epicardial using 40 mm size AtriClip. In second patients, LAA closure was performed completely percutaneously using LARIAT device. For better visualization of LAA shape on fluoroscopy and TEE examination, intraoperatively sterilized 3D LAA model was used during the procedure. In both cases, intraoperative TEE examination confirmed complete LAA closure with no leak. CONCLUSIONS: Left atrial appendage 3D model is a useful tool in preoperative planning of a left atrial appendage occlusion using epicardial approaches with thoracoscopic or percutaneous access using LARIAT device. The quality of low-cost 3D printed LAA model is sufficient in planning minimally invasive procedure.

Efficacy and Safety of the HeartMate Percutaneous Heart Pump During High-Risk Percutaneous Coronary Intervention (from the SHIELD I Trial).

This study aimed to evaluate the use of the HeartMate percutaneous heart pump, a catheter-based axial flow pump designed to provide partial left ventricular support, in patients who underwent high-risk percutaneous coronary intervention (PCI). Patients who are hemodynamically unstable, or at risk of being hemodynamically unstable, while undergoing PCI may require mechanical circulatory support. Fifty high-risk patients were enrolled in a prospective, nonrandomized, multicenter, open-label trial. Primary end points were freedom from hemodynamic compromise during PCI and a composite measure of major adverse events. Patients were followed for 30 days. No patient met the primary performance end point. Six safety end points in 5 patients occurred, including 1 access site complication requiring intervention, 1 cerebrovascular accident, 2 major bleeding complications, and 2 cases of new or worsening aortic insufficiency. No cardiac deaths, myocardial infarctions, or surgical interventions occurred. In conclusion, initial results of the HeartMate percutaneous heart pump for mechanical circulatory support during high-risk PCI are encouraging. Hemodynamic stability was achieved in all patients with a low incidence of adverse events.

Impact of post-dilatation on the reduction of paravalvular leak and mortality after transcatheter aortic valve implantation.

BACKGROUND: Post-implantation paravalvular leak (PVL) remains a significant complication of transcatheter aortic valve implantation (TAVI). More importantly, its occurrence may impact long-term mortality. AIM: We sought to evaluate the effects of balloon post-dilatation (PD) on the reduction of PVL and mortality in patients undergoing TAVI. METHODS: A total of 101 consecutive patients undergoing TAVI were enrolled. Angiography, echocardiography, and the aortic regurgitation index (ARI) were used to assess the severity of PVL before and after balloon PD. Patients were divided into two groups based whether or not PD after TAVI was performed. Reduction of PVL, change of ARI, and clinical outcomes were assessed. RESULTS: Balloon post-dilatation was performed in 23 (22.8%) patients. In 95.6%, PVL reduction was successful (no or mild PVL). PD increased the ARI from 23.4% (22.4-24.0) to 27.1% (26.1-28.3); p < 0.001. Thirty-day mortality rate was 14.1% in the PD (-) group vs. 0.0% in the PD (+) group; p = 0.07. One-year mortality (21.8% vs. 4.3%, p = 0.97) and procedural stroke rate (7.7% vs. 8.7%, p = 0.99) were not different between the groups. CONCLUSIONS: Balloon post-dilatation may be a safe and effective technique to reduce moderate to severe PVL after TAVI.

Incidence of Postoperative Delirium and Its Impact on Outcomes After Transcatheter Aortic Valve Implantation.

There are limited data on the occurrence of postoperative delirium after transcatheter aortic valve implantation (TAVI). We sought to investigate the incidence of delirium after TAVI and its impact on clinical outcomes. A total of 148 consecutive patients who underwent TAVI were enrolled. Of these patients, 141 patients survived hospital stay. The incidence of delirium was assessed in these patients for the first 4 days after the index procedure. The patients were divided into 2 groups based on the presence of delirium. Baseline characteristics, procedural and long-term outcomes, and frailty and quality-of-life indexes were compared among the groups. Of the 141 patients analyzed, 29 patients developed delirium. The transapical access was more common in patients with delirium (51.7% vs 8.9%, p <0.001). A greater median contrast volume load in the delirium group was noted (75 vs 100 ml, p = 0.001). Significantly more patients with delirium were considered as frail before TAVI. Thirty-day and 12-month all-cause mortality rates were higher in the delirium group (0.0% vs 17.2%, p <0.001; and 3.6% vs 37.9%, p <0.001, respectively). Differences in mortality were significant even after adjustment for baseline characteristics. The quality of life at 12 months, assessed by the 3-level version of the EuroQol 5-dimensional questionnaire, was similar in both groups. Despite a relatively minimally invasive character of TAVI as compared with surgery, some patients experience delirium after TAVI. Importantly, the occurrence of delirium after TAVI may help to identify patients with worse short- and long-term outcomes.

Prognostic value of tricuspid regurgitation velocity and probability of pulmonary hypertension in patients undergoing transcatheter aortic valve implantation.

Pulmonary hypertension (PH) is associated with adverse clinical outcomes after transcatheter aortic valve implantation (TAVI). We sought to investigate the effects of tricuspid regurgitant velocity (TRV) and echocardiographic probability of PH on clinical outcomes of patients undergoing TAVI. A total of 148 consecutive patients undergoing TAVI were included and stratified as having "low" (TRV ≤2.8 m/s), "intermediate" (TRV 2.9-3.4 m/s), and "high" (TRV >3.4 m/s) probability of PH. Only the patients from the "high" probability group were considered as patients with PH. All-cause mortality, complications rate and quality of life (QoL) were assessed according to VARC-2 recommendations. Of 148 patients, 65 (43.9%) were considered as patients with PH. These presented with higher NYHA class at baseline (p = 0.027) and had more frequently a history of previous stroke/transient ischemic attack (p = 0.019). A difference in all-cause mortality was noted at 12 months [PH (-) vs. PH (+): 9.6 vs. 21.5%; p = 0.043]; however, it was no longer significant after adjustment for age and gender (OR 2.39, 95% CI 0.91-6.24; p = 0.08). Unadjusted and adjusted rates of all-cause death at maximal follow-up of 13.3 (6.0-31.1) months were higher in patients with PH. However, the presence of PH was not identified as an independent predictor of all-cause mortality at follow-up. No difference in other complications rates and QoL were noted. The presence of TRV >3.4 m/s indicating "high" probability of PH may predict impaired clinical outcomes after TAVI. No impact of PH on QoL outcomes was confirmed.