Complete percutaneous angio-guided approach using preclosing for venoarterial extracorporeal membrane oxygenation implantation and explantation in patients with refractory cardiogenic shock or cardiac arrest.

BACKGROUND: The approach for veno-arterial extracorporeal membrane oxygenation implantation (VA-ECMO) in patients with cardiogenic shock can be either surgical or percutaneous. Complete angio-guided percutaneous implantation and explantation could decrease vascular complications. We sought to describe the initial results of complete percutaneous angio-guided ECMO implantation and explantation using preclosing. METHODS: All consecutive patients who underwent peripheral femoro-femoral VA-ECMO percutaneous implantation for refractory cardiogenic shock or cardiac arrest were enrolled in a prospective registry (03/2018-12/2020). Percutaneous preclosing using two closing devices (Perclose ProGlide, Abbott) inserted before cannulation was used in both femoral artery and vein. Explantation was performed using a crossover technique under angiographic guidance. The occurrence of vascular complication was recorded. RESULTS: Among the 56 patients who underwent percutaneous VA-ECMO implantation for cardiogenic shock or refractory cardiac arrest, 41 underwent preclosing. Femoral vessel cannulation was successful in all patients and total cannulation time was 20 (10-40) min. Weaning from ECMO was possible in 22/41 patients (54%) and 12 (29%) patients were alive at day 30. Significant vascular complications occurred in 2/41 patients. Percutaneous decannulation was performed in 20 patients with 19/20 technical success rate. All femoral arteries and veins were properly closed using the pre-closing devices without bleeding on the angiographic control except for one patient in whom surgical closure of the artery was required. No patient required transfusion for access related significant bleeding and no other vascular complication occurred. Furthermore, no groin infection was observed after full percutaneous implantation and removal of ECMO. CONCLUSION: Emergent complete percutaneous angio-guided VA-ECMO implantation and explantation using pre-closing technique can be an attractive strategy in patients referred for refractory cardiogenic shock.

Computed tomography for transcatheter tricuspid valve development.

BACKGROUND: Patients with severe symptomatic tricuspid regurgitation (TR) are often deemed ineligible for surgical valve repair due to comorbidities. In this setting, transcatheter tricuspid valve replacement (TTVR) is undergoing development, but delivery technique and prosthesis design have yet to be optimized. We sought to assess the challenges of TTVR and the determinants of venous route using computed tomography (CT) analysis. METHODS AND RESULTS: A total of 195 end-diastolic cardiac CT performed prior to surgical correction of a severe TR (n = 38), transcatheter aortic valve replacement (n = 89), or left atrial appendage closure (n = 68) were analyzed. Patients with TR (n = 68; 19 primary and 49 secondary) were compared with patients without (n = 127). Continuous variables with normal and non-normal distributions were compared using Student t test or Mann-Whitney test respectively. The angle from the tricuspid annulus (TA) to the inferior vena cava was tighter (mean = 101 ± 18°) with a broader range of value (44° to 164°) than to the superior vena cava (mean = 143 ± 9°). Patients with TR had rounder TA (eccentricity index of 0.88 ± 0.08, p < 0.001), with a larger area (p < 0.0001), and septolateral (45.3 ± 8.0 mm, p < 0.0001) and anteroposterior (44.4 ± 7.4 mm, p < 0.0001) diameters than patients without. The distances from the TA to the coronary sinus, the right ventricular outflow tract, and the moderator band were respectively 11.4 ± 3.8 mm, 17.2 ± 3.4 mm, and 31.0 ± 6.7 mm, without differences between groups. CONCLUSION: The transjugular access for TTVR is straighter and more reproducible than the transfemoral access. Prosthesis development may be challenged by the close position of the coronary sinus, the presence of a moderator band, and the large TA size of patients with severe TR. KEY POINTS: • The tricuspid annulus is larger in patients with severe tricuspid regurgitation, confirming existing data. • The coronary sinus ostium is close to the tricuspid annulus, requiring a prosthesis with a short atrial length. • The transjugular venous route may be the preferred access to the tricuspid annulus, straighter with less inter-individual variations than the transfemoral route.

Perioperative Outcomes of Adjunctive Hypnotherapy Compared with Conscious Sedation Alone for Patients Undergoing Transfemoral Transcatheter Aortic Valve Implantation.

Transcatheter aortic valve implantation (TAVI) using a transfemoral approach under local anesthesia with conscious sedation (LACS) is becoming an increasingly common TAVI strategy. However, patients who are awake during the TAVI procedure can experience stress, anxiety, and pain, even when LACS is used. Clinical hypnotherapy is an anxiolytic intervention that can be beneficial for patients undergoing invasive surgery. This study aimed to assess the perioperative outcomes of adjunctive hypnotherapy undergoing transfemoral TAVI with LACS.Consecutive patients (n = 143) with symptomatic severe aortic stenosis who underwent transfemoral TAVI with LACS only (n = 107) or with LACS and hypnotherapy (n = 36) between January 2015 and April 2016 were retrospectively included in the study. The clinical outcomes were compared between the two groups. The LACS with hypnotherapy group had a significantly shorter length of stay in the intensive care unit (ICU; LACS only versus LACS with hypnotherapy: 4.0 (4.0-5.5) days versus 3.0 (3.0-5.0) days, P < 0.01). Moreover, the use of anesthetics (propofol and remifentanil) and norepinephrine was significantly lower in the LACS with hypnotherapy group (e.g., for propofol, LACS only versus LACS with hypnotherapy: 96.4 ± 104.7 mg versus 15.0 ± 31.8 mg, P < 0.001). The multiple regression analysis showed that being male, hypnotherapy, and the composite complication score were independently associated with the length of stay in the ICU.The adjunctive hypnotherapy on LACS among transfemoral TAVI patients may facilitate perioperative management. However, a prospective randomized study is necessary to confirm the efficacy of hypnotherapy among TAVI patients.

Outcomes and safety of same-day discharge after percutaneous coronary intervention: A 10-year single-center study.

AIMS: Same-day discharge (SDD) after percutaneous coronary intervention (PCI) was safe and cost-effective in randomized and observational studies but faces limited acceptance due to concerns about early adverse events. Our aim was to evaluate early outcomes after SDD PCI in a high-volume urban PCI center over 10 years. METHODS AND RESULTS: From 2007 to 2016, 1,635 unselected patients had PCI at our ambulatory cardiac care unit, mainly for stable ischemic heart disease (SIHD). Among them, 1,073 (65.6%), most of whom underwent ad hoc PCI, were discharged on the same day and 562 (34.4%) were admitted, for adverse events during PCI (n = 60) or within the next 4-6 hr (n = 52) or chiefly due to physician preference (n = 450). In the SDD group, radial access was used in 98.5% of patients; 36% and 15% of patients had two- and three-vessel disease, respectively; and two-vessel PCI was performed in 11% of patients. No MACCEs (death, myocardial infarction, stroke, urgent repeat PCI/CABG, and major vascular complications) occurred within 24 hr post-discharge. Two patients were readmitted on the next day for chest pain but did not require repeat PCI. CONCLUSION: SDD after successful PCI without complications within the next 4-6 hr is safe and feasible in most patients with SIHD. Among 1,035 SDD patients treated over 10 years, only two required readmission, and none experienced major cardiac adverse events such as death or stent thrombosis. SDD is safe for the patient and cost-effective for the healthcare system and should be implemented more widely.

Intra-coronary morphine versus placebo in the treatment of acute ST-segment elevation myocardial infarction: the MIAMI randomized controlled trial.

BACKGROUND: Experimental studies suggest that morphine may protect the myocardium against ischemia-reperfusion injury by activating salvage kinase pathways. The objective of this two-center, randomized, double-blind, controlled trial was to assess potential cardioprotective effects of intra-coronary morphine in patients with ST-segment elevation myocardial infarction (STEMI) referred for primary percutaneous intervention. METHODS: Ninety-one patients with STEMI were randomly assigned to intracoronary morphine (1 mg) or placebo at reperfusion of the culprit coronary artery. The primary endpoint was infarct size/left ventricular mass ratio assessed by magnetic resonance imaging on day 3-5. Secondary endpoints included the areas under the curve (AUC) for troponin T and creatine kinase over three days, left ventricular ejection fraction assessed by echocardiography on days 1 and 6, and clinical outcomes. RESULTS: Infarct size/left ventricular mass ratio was not significantly reduced by intracoronary morphine compared to placebo (27.2% ± 15.0% vs. 30.5% ± 10.6%, respectively, p = 0.28). Troponin T and creatine kinase AUCs were similar in the two groups. Morphine did not improve left ventricular ejection fraction on day 1 (49.7 ± 10.3% vs. 49.3 ± 9.3% with placebo, p = 0.84) or day 6 (48.5 ± 10.2% vs. 49.0 ± 8.5% with placebo, p = 0.86). The number of major adverse cardiac events, including stent thrombosis, during the one-year follow-up was similar in the two groups. CONCLUSIONS: Intracoronary morphine at reperfusion did not significantly reduce infarct size or improve left ventricular systolic function in patients with STEMI. Presence of comorbidities in some patients may contribute to explain these results. TRIAL REGISTRATION: ClinicalTrials.gov, NCT01186445 (date of registration: August 23, 2010).

Coronary Procedures After TAVI With the Self-Expanding Aortic Bioprosthesis Medtronic CoreValve™, Not an Easy Matter.

OBJECTIVES: To evaluate the feasibility of coronary procedures after transcatheter aortic valve implantation (TAVI) with the CoreValve™ device. BACKGROUND: Due to its design, CoreValve™ prosthesis may interfere with coronary procedures. Data on this issue are sparse. METHODS: Between 2007 and 2015, 550 patients underwent CoreValve™ TAVI in our hospital. Among them, 16 underwent coronary angiogram after TAVI and were included in our retrospective study. For each patient, we compared the characteristics of coronary angiograms performed before and after TAVI. RESULTS: Coronary angiogram was deemed successful in 9 patients. The mean number of different catheters used in attempts to cannulate the coronary arteries was 3.6 ± 1.4 and the rate of selective intubation was low. Fluoroscopy time (13.2 ± 5.8 vs. 7.2 ± 4.6 min, P = 0.003), dose area product (5,347 ± 4,919 vs. 3,433 ± 3,420 cGy/m2 , P = 0.004), and contrast volume (157.7 ± 69.6 vs. 108.3 ± 42.6 mL, P = 0.006) were more important in coronary angiograms performed after CoreValve™ implantation. Percutaneous coronary intervention was successfully performed in 6 out of 7 patients who required it. CONCLUSION: Coronary procedures after CoreValve™ TAVI are feasible, but challenging. This problem is currently rare but will be more common as the indications of TAVI are expanded to younger patients with longer life expectancies. Recommendations for post-TAVI coronary procedures are needed, particularly for centers unfamiliar with the management of post-TAVI patients.

Outcomes following pacemaker implantation after transcatheter aortic valve implantation with CoreValve(®) devices: Results from the FRANCE 2 Registry.

AIMS: Permanent pacemaker (PPM) implantation following high-degree atrioventricular block is frequently required after transcatheter aortic valve implantation (TAVI) using CoreValve(®) . Recent improvement of the delivery system (CoreValve Accutrak(®) ) aimed to ease delivery and reduce the PPM rate. Our study evaluated the incidences of PPM implantation following use of CoreValve(®) or CoreValve Accutrak(®) and the clinical outcome of these patients. METHODS AND RESULTS: A total of 883 patients (82 ± 7 years; 41.3% female) with severe symptomatic aortic stenosis and self-expanding bioprosthesis implantation were included between January 2010 and October 2011 in 29 centers from the FRANCE 2 Registry. Follow-up data were available in 833 patients. CoreValve(®) and CoreValve Accutrak(®) were used in 343 (41.2%) and 490 (58.8%) patients, respectively. During a mean follow-up of 242 ± 179 days, all-cause mortality was similar in patients with versus without PPM implantation (16.3 vs. 16.9%, P = 0.832).There was no significant difference in the PPM incidence in CoreValve(®) and CoreValve Accutrak(®) patients (30.4% vs. 27.5%, P = 0.846). CONCLUSION: PPM implantation remained frequent after TAVI using CoreValve Accutrak(®) . All-cause mortality was similar in patients with or without PPM implantation. The new device failed to show a significant decrease in PPM implantation incidence after TAVI. © 2015 Wiley Periodicals, Inc.

Patients without prolonged QRS after TAVI with CoreValve device do not experience high-degree atrio-ventricular block.

OBJECTIVE: To identify clinical and electrical factors predicting delayed high-degree atrio-ventricular block (AVB) after transcatheter aortic valve implantation (TAVI). BACKGROUND: TAVI is a new technique for treating severe aortic valve stenosis in patients at high surgical risk but can be followed by high-grade AVB requiring permanent pacing (PP). METHODS AND RESULTS: The study included 79 patients (82 ± 17 years, Euroscore = 23% ± 10%) free of PP need before and immediately after TAVI procedure. Delayed high-degree AVB was defined by types 2 or 3 AVB diagnosed at least 24 hr after the index procedure. Permanent pacemaker implantation was performed for all these patients. We compared clinical and electrical variables before and after TAVI in patients with delayed AVB or not. TAVI was performed successfully in all patients. The 21 (26%) patients who exhibited delayed high-grade AVB had significantly deeper prosthesis implantation (12 ± 4 mm vs. 9 ± 5 mm, P = 0.03) and wider post-TAVI QRS duration (155 ± 17 msec vs. 131 ± 25 msec, P = 0.0004), with no difference in baseline QRS duration. Post-TAVI QRS duration was the only independent predictor of post-TAVI permanent for delayed high-degree AVB (P = 0.02). After a mean follow-up of 10 ± 8 months, all 21 patients with post-TAVI QRS ≤ 128 msec were free of high-grade AVB, whereas 21/55 (38%) patients with post-TAVI QRS >128 msec had PP (P = 0.0016). CONCLUSION: Delayed (>24 hr after the procedure) high-grade AVB necessitating PP is common after TAVI. QRS duration measured immediately after TAVI was the best independent predictor of PP in this population. Patients with QRS ≤ 128 msec immediately after TAVI had no risk of requiring PP.

Transcatheter aortic valve implantation when classical access routes are unavailable.

A 90-year-old woman with symptomatic degenerative aortic stenosis had a logistic Euroscore greater than 53.29%, indicating a high surgical risk. She was therefore advised to undergo transcatheter aortic valve implantation. Both iliac arteries showed subocclusive calcifications, and the left subclavian artery was narrow and calcified. The left common carotid (LCC) artery was chosen as the access route. After surgical exposure of the LCC artery, the Corevalve Revalving 29-mm bioprosthesis was implanted successfully. No access-site complications occurred. In our experience, a substantial proportion of elderly patients have vascular lesions precluding use of the femoral route. Brachiocephalic access routes may be valuable when no other options are available.

Left Ventricle Unloading Through Pulmonary Artery in Patients With Venoarterial Extracorporeal Membrane Oxygenation.

Venoarterial extracorporeal membrane oxygenation (VA-ECMO) initiation for patients with cardiogenic shock or cardiac arrest is an attractive strategy since it provides a quick restoration of organ perfusion. One major limitation of VA-ECMO is left ventricle (LV) distension which is associated with poor prognosis. To prevent or treat LV distension, LV decompression may be required. Current strategies for LV decompression have some contraindications, carry a high risk of complications and, for some of them concerns remain regarding their effectiveness. We here describe our experience in two adult patients treated with VA-ECMO in whom indirect LV unloading using pulmonary artery venting was performed for the prevention and the treatment of LV distension, respectively. The placement of the venting cannula in the pulmonary trunk was quick, easy and safe and was associated with the resolution of LV distension. These results suggest that pulmonary artery venting may be an attractive strategy for indirect LV decompression during VA-ECMO.

Timing of aortic valve replacement in high-gradient severe aortic stenosis: impact of left ventricular ejection fraction.

BACKGROUND: Patients with high-gradient (HG) severe aortic stenosis (AS) and left ventricular (LV) dysfunction are at high risk of death. The optimal timing for aortic valve replacement (AVR) is not defined by guidelines. The objective was to define the optimal timing to perform isolated AVR in patients with HG-AS and severe LV dysfunction. METHODS: We retrospectively included 233 consecutive patients admitted for severe HG-AS (aortic valve area <1cm2 and mean gradient ≥40mmHg). Severe LV dysfunction was defined by LV ejection fraction ≤35% (LVEF). All-cause mortality while waiting for AVR and after the intervention (30 days) was compared in patients with (n = 28) and without (n = 205) LVEF ≤35%. RESULTS: Patients with HG-AS and severe LV dysfunction had a higher risk profile than those with LVEF >35%. AVR was performed in 93% (218/233) of patients, 41% by surgery (SAVR) and 53% by transcatheter (TAVR). TAVR was the preferred method to treat HG-AS patients with LVEF ≤35%. All-cause mortality while waiting for AVR was higher in patients with severe LV dysfunction (22% vs. 2.0%, p < 0.001) and occurred within a shorter time (12 [8-26] days vs. 63 [58-152] days, p = 0.010) compared to those with LVEF >35%. All death in HG-AS patients with a severe LV dysfunction occurred within the first month. Postoperative mortality was low (1.3%), irrespective of LVEF. CONCLUSIONS: AVR should be performed promptly after Heart Team decision in patients with HG severe AS and LVEF ≤35% because of a very high and premature risk of death while waiting for intervention.

Heart rate increment analysis is not effective for sleep-disordered breathing screening in patients with chronic heart failure.

Frequency domain analysis of heart rate variation has been suggested as an effective screening tool for sleep-disordered breathing (SDB) in the general population. The aim of this study was to assess this method in patients with chronic congestive heart failure (CHF). We included prospectively 84 patients with stable CHF, left ventricular ejection fraction (LVEF) <45% and sinus rhythm. The patients underwent polygraphy to measure the apnoea/hypopnoea index (AHI) and simultaneous Holter electrocardiogram monitoring to measure the power spectral density of the very low frequency component of the heart rate increment, expressed as the percentage of total power spectral density [% very low frequency increment (%VLFI)]. %VLFI could be determined in 54 patients (mean age, 52.8 +/- 12.3 years; LVEF, 33.5 +/- 9.8%). SDB defined as AHI > or =15 h(-1) was diagnosed in 57.4% of patients. Percent VLFI was not correlated with AHI (r = 0.12). Receiver-operating characteristic curves constructed using various AHI cut-offs (5-30 h(-1)) failed to identify a %VLFI cut-off associated with SDB. The 2.4% VLFI cut-off recommended for the general population of patients with suspected SDB had low specificity (35%) and low positive and negative predictive values (35% and 54%, respectively). Heart rate increment analysis has several limitations in CHF patients and cannot be recommended as an SDB screening tool in the CHF population.

Second Percutaneous Mitral Valve Implantation to Treat Acute Hemolysis Complicating Mitral Valve in Ring Implantation.

We report the case of acute hemolysis after percutaneous transmitral valve implantation in a failed mitral valve repair. Transthoracic echocardiography revealed a high velocity mild mitral regurgitation that could be responsible for the hemolysis. The implantation of a second 26-mm SAPIEN 3 valve (Edwards Lifesciences, Irvine, California) allowed complete regression of the hemolysis. (Level of Difficulty: Intermediate.).

Successful percutaneous treatment of an anomalous left circumflex coronary artery occlusion after tricuspid valve repair.

The risk of coronary artery injury during valve surgery is higher in case of anomalous coronary artery origin and trajectory. Unlike previous reports on coronary obstruction related to aortic or mitral surgery, we report the first case, to the best of our knowledge, of an anomalous left circumflex artery occlusion after tricuspid valve repair, and its successful percutaneous treatment.

Peridevice Leak After Left Atrial Appendage Closure: Incidence, Risk Factors, and Clinical Impact.

BACKGROUND: Limited studies reported the rate and clinical impact of peridevice leaks (PDL) after percutaneous left atrial appendage closure (LAAC). METHODS: All consecutive patients with a nonvalvular atrial fibrillation admitted for LAAC between November 2011 and October 2016 were prospectively enrolled. The follow-up included clinical, transesophageal echocardiography, and/or cardiac computed tomography angiogram (CCTA). PDL was defined by the presence of contrast within the left atrial appendage on CCTA, and Major Adverse Cardiac Event (MACE) included stroke, device-related thrombosis, and cardiovascular death. RESULTS: Overall, 77 patients (mean CHA2DS2-VASc score = 4.4 ± 1.5 and mean HAS-BLED = 3.4 ± 1.1) were implanted using Amplatzer Cardiac Plug (n = 24), Amulet (n = 37), or Watchman devices (n = 16). Indications were stroke recurrence despite adequate oral anticoagulation (OAC, n = 6) or contraindication to long-term OAC (n = 71). From 3-month to 12-month CCTA follow-up, the PDL rate decreased from 68.5% to 56.7% (P = 0.02), without any difference between the various devices. Patients with PDL were more often in permanent atrial fibrillation, and had a larger landing zone diameter, a lower ratio of device compression, and a more frequent off-axis position of the device. A device compression ratio < 10% was the only parameter associated with PDL occurrence. During follow-up (median 236 days) the MACE rate was 9.1%, with no statistically significant difference between patients with vs without PDL (12% vs 4.3%, P = 0.3). CONCLUSIONS: The PDL rate detected by CCTA after LAAC was high, especially in cases with a low device compression ratio (< 10%), but decreased over time. The incidence of MACE was quantitatively greater with PDL, but the difference was not statistically significant. Larger studies are needed to determine the clinical importance of PDL.

Percutaneous Left Atrial Appendage Closure in Patients With Inferior Vena Cava Filters: A Case Series.

OBJECTIVES: Percutaneous procedures through femoral access in patients with inferior vena cava (IVC) filter may be at risk of complications. We evaluated the feasibility and safety of left atrial appendage (LAA) closure through femoral access in patients previously implanted with IVC filter. METHODS: From November 2011 to March 2018, a total of 5 patients with history of IVC filter implantation were referred to our center for percutaneous LAA closure, representing 3.6% of the 137 procedures performed during the study period. The IVC filter devices were placed from 2 to 26 months before the index procedure. RESULTS: LAA closure was successfully implanted in all cases using an Amulet device in 3 patients and a Watchman device in 2 patients. A femoral approach was performed in all patients using 12 or 14 Fr sheaths. Before crossing IVC filters, venographies did not detect any thrombus. All steps of IVC filter crossing were performed under fluoroscopic guidance. No immediate or late complications related to the procedure occurred after 10.1 ± 3.9 months of follow-up. CONCLUSION: LAA closure in patients with previously implanted IVC filter is safe as long as careful x-ray monitoring is observed.

Impact of QRS Duration on Decision of Early Removal of Pacing Catheter After Transcatheter Aortic Valve Replacement With CoreValve Device.

The purpose of this study was to determine the predictability of QRS duration (QRSd) for temporary pacing catheter removal in patients implanted with CoreValve. Permanent pacemaker implantation is a known complication after transcatheter aortic valve replacement (TAVI) with CoreValve. Although post-TAVI QRSd is highly predictive for advanced atrioventricular block (AVB), management of delayed AVB after TAVI remains unclear. We conducted a multicentric, prospective study of 156 consecutive patients who underwent TAVI with CoreValve between December 2010 and January 2013. Patients who had acute AVB after TAVI were excluded (n = 25). We classified the patients into 2 groups based on the post-TAVI QRSd. Patients with QRSd <120 ms were assigned to early pacing catheter removal group (n = 34), and patients with QRSd ≥120 ms were assigned to keep the pacing catheter with monitoring group (n = 97). No patient required permanent pacemaker implantation in the early pacing catheter removal group, whereas 38 patients with QRSd ≥120 ms had a delayed AVB (QRSd <120 ms vs ≥120 ms: 0% vs 39%, p = 0.0001). The intensive care unit stay length, 30-day mortality, and incidence of complications were lower in the early catheter removal group. Post-TAVI QRSd allows patient selection for early removal of pacing catheter in patients implanted with CoreValve.

Prognostic value of new onset atrial fibrillation after transcatheter aortic valve implantation: A FRANCE 2 registry substudy.

BACKGROUND: The development of new onset atrial fibrillation (NOAF) post-transcatheter aortic valve implantation (TAVI) is common and may be associated with an adverse prognosis. This study seeks to identify incidence, predictors, and impact of NOAF post-TAVI. METHODS: From the multicenter study of the French national transcatheter aortic valve implantation registry, FRANCE 2, a total of 1959 patients with sinus rhythm prior to TAVI were enrolled into this study. The incidence of post-TAVI NOAF, predictors of development of NOAF and impact on 30-day and 1-year-mortalities were assessed. RESULTS: Of the 1959 TAVI patients (mean-age: 82.6 ± 7.5 years, mean-logistic-EuroSCORE: 21.8 ± 14.3), 149 (7.6%) developed NOAF with the remaining 1810 (92.4%) control patients demonstrating no evidence of AF as defined by the Valve Academic Research Consortium (VARC). Advanced age and major and life-threatening bleeding were independent predictors of NOAF (95% CI: 0.93-0.99; p=0.006, 95% CI: 1.58-4.00; p<0.001, 95% CI: 1.09-3.75; p=0.025, respectively). A trend towards a higher incidence of major and life-threatening bleeding was observed in the patients undergoing TAVI via the transapical (TA)-approach compared with the transfemoral (TF)-approach. Both 30-day and cumulative 1-year-mortalities were significantly higher in patients with NOAF compared to patients without NOAF (3.0% vs. 7.4%; p=0.005, 9.1% vs. 20.8%; p<0.001, respectively). In addition, NOAF was an independent predictor of 30-day and 1-year-mortalities (HR: 2.16; 95% CI: 1.06-4.41; p=0.033, HR: 2.12; 95% CI: 1.42-3.15; p<0.001, respectively). CONCLUSION: Advanced age and major and life-threatening bleeding were independently associated with increased incidence of NOAF, which itself was an independent predictor of 30-day and 1-year-mortalities. With regards to the various transcatheter approaches, a trend towards a higher incidence of major and life-threatening bleeding was observed only with the TA-approach.

Effect of body mass index <20 kg/m(2) on events in patients who underwent transcatheter aortic valve replacement.

The Valve Academic Research Consortium-2 has defined body mass index (BMI) <20 as indicative of frailty, which may be one of the co-morbidities not captured by traditional risk factors after transcatheter aortic valve replacement (TAVR). This study aimed to assess the impact of low BMI on clinical outcomes after TAVR. A total of 777 consecutive patients scheduled for TAVR were classified into 3 groups as BMI <20 (n = 56), 20 to 24.9 (n = 322), and ≥25 (n = 399). Procedural complications and clinical outcomes were compared among the 3 groups. They were also analyzed according to propensity-matching model A (BMI <20 [n = 50] vs ≥20 [n = 50]), model B (BMI <20 [n = 50] vs 20 to 24.9 [n = 50]), and model C (BMI <20 [n = 47] vs ≥25 [n = 47]). The differences in baseline characteristics among the 3 groups were adequately adjusted in 3 matched models. Valve Academic Research Consortium-2-defined end points and other complications were similar among the 3 groups in each model. Kaplan-Meier curves indicated no significant differences in cumulative 30-day survival (BMI <20 [91.0%] vs 20 to 24.9 [86.3%], p = 0.33; BMI <20 [91.0%] vs ≥25 [91.4%], p = 0.91, respectively) and 1-year survival (BMI <20 [74.3%] vs 20 to 24.9 [71.8%], p = 0.71; BMI <20 [74.3%] vs ≥25 [77.0%], p = 0.71; respectively). These survival rates were also similar in each of the 3 matched models. In conclusion, BMI <20 was not associated with increased early or midterm mortality. BMI <20 alone may not constitute an additional co-morbidity factor in patients who underwent TAVR.