Transcatheter or Surgical Aortic Valve Replacement in Patients With Severe Aortic Stenosis and Small Aortic Annulus: A Randomized Clinical Trial.

BACKGROUND: The optimal treatment in patients with severe aortic stenosis and small aortic annulus (SAA) remains to be determined. This study aimed to compare the hemodynamic and clinical outcomes between transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR) in patients with a SAA. METHODS: This prospective multicenter international randomized trial was performed in 15 university hospitals. Participants were 151 patients with severe aortic stenosis and SAA (mean diameter <23 mm) randomized (1:1) to TAVR (n=77) versus SAVR (n=74). The primary outcome was impaired valve hemodynamics (ie, severe prosthesis patient mismatch or moderate-severe aortic regurgitation) at 60 days as evaluated by Doppler echocardiography and analyzed in a central echocardiography core laboratory. Clinical events were secondary outcomes. RESULTS: The mean age of the participants was 75.5±5.1 years, with 140 (93%) women, a median Society of Thoracic Surgeons predicted risk of mortality of 2.50% (interquartile range, 1.67%-3.28%), and a median annulus diameter of 21.1 mm (interquartile range, 20.4-22.0 mm). There were no differences between groups in the rate of severe prosthesis patient mismatch (TAVR, 4 [5.6%]; SAVR, 7 [10.3%]; P=0.30) and moderate-severe aortic regurgitation (none in both groups). No differences were found between groups in mortality rate (TAVR, 1 [1.3%]; SAVR, 1 [1.4%]; P=1.00) and stroke (TAVR, 0; SAVR, 2 [2.7%]; P=0.24) at 30 days. After a median follow-up of 2 (interquartile range, 1-4) years, there were no differences between groups in mortality rate (TAVR, 7 [9.1%]; SAVR, 6 [8.1%]; P=0.89), stroke (TAVR, 3 [3.9%]; SAVR, 3 [4.1%]; P=0.95), and cardiac hospitalization (TAVR, 15 [19.5%]; SAVR, 15 [20.3%]; P=0.80). CONCLUSIONS: In patients with severe aortic stenosis and SAA (women in the majority), there was no evidence of superiority of contemporary TAVR versus SAVR in valve hemodynamic results. After a median follow-up of 2 years, there were no differences in clinical outcomes between groups. These findings suggest that the 2 therapies represent a valid alternative for treating patients with severe aortic stenosis and SAA, and treatment selection should likely be individualized according to baseline characteristics, additional anatomical risk factors, and patient preference. However, the results of this study should be interpreted with caution because of the limited sample size leading to an underpowered study, and need to be confirmed in future larger studies. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03383445.

Superior vena cava tear during transvenous lead extraction: Medical management in hemodynamically stable patients.

INTRODUCTION: Superior vena cava (SVC) tear is the most lethal complication during transvenous lead extraction (TLE) with a mortality rate as high as 50%. Treatment involves aggressive attempts to maintain cardiac output and immediate sternotomy to localize and repair the vascular tear. Occlusion balloons have been developed to provisionally occlude the lacerated SVC and to provide hemodynamic stability allowing time for surgery. In case of mediastinal hematoma without hemodynamic instability, the strategy remains unclear. METHODS AND RESULTS: We describe two cases of SVC tear during TLE. The first case was a 60-year-old man who presented with a right ventricular single-chamber defibrillator lead fracture and innominate vein stenosis. The RV lead was removed using a laser sheath causing a mediastinal hematoma with no active bleeding during surgical exploration few hours later. The second case was a 28-year-old man that presented with a right atrial (RA) lead fracture and RV lead insulation failure in a dual-chamber defibrillator (ICD). CONCLUSION: Both the RA and RV leads were removed with mechanical sheaths, and a mediastinal hematoma was medically managed.

Impact of COVID-19 Pandemic on Young Children With Feeding and Eating Problems and Disorders and Their Families.

OBJECTIVES: The incidence of feeding and eating problems and disorders (FEPD) in children increased during the coronavirus disease 2019 (COVID-19) pandemic. The aim of this study was to assess the impact of the COVID-19 pandemic on young children with FEPD and their parents. METHODS: Cross-sectional survey: parents of children with FEPD (0-11 years) in the Netherlands completed an online questionnaire (January-April 2021). This questionnaire included 4 demographic questions (including criteria of pediatric feeding disorder [PFD] and/or avoidant/restrictive food intake disorder [ARFID]) and 11 questions related to experienced impact of the COVID-19 pandemic. Parental responses regarding children with FEPD (including PFD and ARFID) were compared with those of healthy controls (HCs). RESULTS: In total, 240 children (median age, 5.5 years; interquartile range [IQR], 3.5-7.9 years; 53.3% female) were included; 129 children with FEPD and 111 HC. Most children with FEPD fulfilled criteria for PFD (n = 119; 92.2%) and/or ARFID (n = 117; 90.7%). Parents of children with FEPD reported more stress (of their child [ P = 0.014] and parental stress [ P = 0.014]), worse eating by the child ( P < 0.001), more negative relations within the family ( P = 0.006), and less support from the environment ( P = 0.001) compared with parents of HC during the COVID-19 pandemic than before. CONCLUSIONS: It seems that the COVID-19 pandemic had great impact on young children with FEPD and their parents because parents of children with FEPD reported significantly more perceived stress within both the child and parents, more difficult eating behavior of the child, more negative behavior between family members, and less support from the environment as compared with HC.

Macroscopic and microscopic features of surgically explanted transcatheter aortic valve prostheses.

OBJECTIVES: With the extended indications of transcatheter aortic valve (TAV) replacement (TAVR) to lower-risk patients, there is an increasing number of patients requiring surgical explantation of failed TAV. We sought to describe macroscopic and microscopic features of surgically explanted percutaneous aortic valve prostheses. METHODS: Preoperative and surgical characteristic of patients undergoing surgical explantation of TAV were retrospectively analyzed from 2007 to 2020. Surgical and pathologic features of these valves, and outcomes of the surgical valve replacement were described. RESULTS: Out of 1764 patients who underwent a TAVR procedure, 21 were operated for TAV failure. Isolated or combined indications for surgery included: significant paravalvular leak (n = 15), delayed prosthesis migration (n = 5), significant increase of trans-TAV gradients (n = 6), and endocarditis (n = 3). Mean time elapsed between TAVR and explantations was 674.9 ± 803.9 days. Macroscopic lesions found on explanted percutaneous valves were severe adhesions to the aorta (n = 10), calcifications (n = 7), leaflet thrombosis (n = 4), and vegetations (n = 3). Except for patients with endocarditis, one or more pathological lesions were found in 15 patients. Pathology analyses on these valves showed fibro-calcific degenerations (n = 12), pannus formation (n = 9), and chronic inflammation (n = 3). One patient (4.8%) died after surgical explantation, and 13 (61.9%) had concomitant procedures. The survival rate at 1 year was 94.4%. CONCLUSIONS: Microscopic findings of fibro-calcific leaflet degeneration, and pannus formation in addition to macroscopic calcification and thrombosis present early, (within a mean of 2 years) after TAVR. Further investigation with a higher number of patients and echocardiographic follow-up is warranted.

Aortic Stenosis and Small Aortic Annulus.

The presence of a small aortic annulus poses a considerable challenge in the management of patients with severe aortic stenosis, especially in elderly women, where it is a very frequent finding. The optimal approach for treating these patients remains controversial, and several surgical strategies such as aortic root enlargement, supra-annular stented prosthetic valves, stentless bioprosthesis, and sutureless bioprostheses have been proposed to improve valve hemodynamics and clinical outcomes. More recently, transcatheter aortic valve replacement has emerged as a valid alternative for the treatment of aortic stenosis and excellent valve hemodynamic results have been observed among patients with a small aortic annulus. The purpose of this review is to provide an overview of the current definition, prevalence, and clinical impact of small aortic annulus in patients with aortic stenosis, and evaluate the different therapeutic strategies currently available to improve valve hemodynamics and outcomes in this population.

Timing and evolution of advanced conduction disturbances in patients with right bundle branch block undergoing transcatheter aortic valve replacement.

AIMS: This study sought to determine the timing and evolution over time of advanced conduction disturbances (CDs) in patients with baseline right bundle branch block (RBBB) undergoing transcatheter aortic valve replacement (TAVR). METHODS AND RESULTS: One hundred and ten consecutive patients with pre-existing RBBB were included (out of 1341, 8.2%). All arrhythmias during the hospitalization period were recorded. Follow-up was performed at 30 days, 1 year, and yearly thereafter. Conduction recovery and ventricular pacing percentage (VPP) was evaluated at 30 days in those patients with permanent pacemaker implantation (PPMI). Sixty-one (55.5%) patients suffered advanced CDs [97% complete or high-degree atrioventricular block (CHB/HAVB)], and the vast majority (98%) occurred within the first 3 days post-procedure (intraprocedural: 85%). Fifty-two (47.3%) patients had PPMI (vs. 11.0% in non-RBBB patients, P < 0.001). Ventricular pacing percentage at 1 month was higher in patients with persistent-intraprocedural CHB/HAVB compared to those with transient-intraprocedural or post-procedural CHB/HAVB [99 (interquartile range, IQR 97-100)% vs. 72 (IQR 30-99)%, P = 0.02]. Complete recovery (VPP < 1%) was observed in only one patient (2%) with CHB/HAVB. After hospital discharge, no symptomatic bradyarrhythmias or sudden death occurred within 30 days. Patients with pre-existing RBBB exhibited a higher risk of PPMI at 4-year follow-up (26% vs. 8% in non-RBBB patients, P < 0.001). CONCLUSION: In patients with pre-existing RBBB, the vast majority of advanced CDs occurred within the 3 days following TAVR, and most did not recover at 1-month, particularly those with intra-procedural persistent CHB/HAVB. These results should help to determine the hospitalization length and timing of PPMI in RBBB patients undergoing TAVR.

Clinical and Technical Characteristics of Coronary Angiography and Percutaneous Coronary Interventions Performed before and after Transcatheter Aortic Valve Replacement with a Balloon-Expandable Valve.

OBJECTIVES: To report on the feasibility and technical differences between coronary procedures performed before and after TAVR with the balloon-expandable Edwards-SAPIEN or the SAPIEN XT valves. BACKGROUND: Coronary artery disease (CAD) and aortic stenosis often coexist. Transcatheter aortic valve replacement (TAVR) is emerging as a treatment for younger and lower surgical risk patients who might not present with clinically evident CAD before TAVR. The demand for performing post-TAVR coronary angiograms (CAs) and percutaneous coronary interventions (PCIs) will thus increase, posing new technical challenges. METHODS: Over 1000 TAVRs were performed at the Quebec Heart and Lung Institute, of which 616 with the abovementioned valves. Of these, 28 patients had an analyzable pre- and post-TAVR CAs and 13 patients had pre- and post-TAVR PCIs performed. Procedural characteristics were gathered from all coronary procedures and subsequently compared amongst the same type of procedure performed at these two distinct time periods. RESULTS: Neither CAs-nor PCIs-performed after valve implantation revealed significant differences regarding arterial access site, catheter diameter, number of diagnostic or guiding catheters used, procedural duration, fluoroscopy time, or achievement of selective coronary injection. Lesion location and classification, as well as the preference of using a drug-eluting stent, remained unchanged. During post-TAVR CA, the amount of contrast delivered and the radiation dose area product were significantly lower compared with pre-TAVR CA values. CONCLUSIONS: Performance of CA and PCI after TAVR with a balloon-expandable valve appears unaffected by its presence.

A new cognitive behavior therapy for adolescents with avoidant/restrictive food intake disorder in a day treatment setting: A clinical case series.

OBJECTIVE: Avoidant/restrictive food intake disorder (ARFID) is a new diagnosis in the DSM-5 Feeding and Eating Disorders section, for which very limited treatment research has been carried out, yet. A new, 4-week exposure based cognitive behavioral therapy (CBT) day treatment, which integrated the inhibitory learning principles, was developed for adolescents with ARFID, and tested in the current study. METHOD: A nonconcurrent multiple baseline design was used in a clinical case series of eleven 10- to 18-year-old patients. After baseline, the 4-week CBT followed. Measurements of DSM-5 ARFID diagnosis, food neophobia and related measures such as body weight and length, were taken at baseline (t1), at the end of the 4-week intensive day treatment (t2) and 3 months after treatment (follow-up, t3). A food selectivity test, a 1-week food diary, and behavioral measures on food intake were also taken at baseline and at 3-month follow-up. Furthermore, continuous measurements of believability of dysfunctional cognitions, anxiety, and food acceptance were taken throughout the 4-weeks day treatment. RESULTS: At follow-up, 10 out of 11 patients were in remission and had a healthy body weight and an average, age-adequate nutritional intake. For most patients, food neophobia scores decreased to a nonclinical range. The belief in dysfunctional cognitions and anxiety levels decreased during treatment. DISCUSSION: This new exposure-based CBT for adolescents with ARFID seems promising. These results may be very useful for clinical practice and stimulate further development of effective CBT interventions in the area of ARFID.

Significant mitral regurgitation in patients undergoing TAVR: Mechanisms and imaging variables associated with improvement.

BACKGROUND: Significant mitral regurgitation (MR) is associated with poorer outcomes in patients undergoing transcatheter aortic valve replacement (TAVR). Factors associated with MR improvement have not been studied thoroughly. METHODS: Retrospective analysis of consecutive patients treated with TAVR with more than mild MR at baseline. MR evolution was assessed at 1-3 and 6-12 months after intervention. MR severity and mechanisms were assessed by echocardiography. Mitral annulus calcification (MAC) was quantified using preoperative cardiac CT. RESULTS: From 674 consecutive TAVR recipients, 78 with more than mild MR had a 6-12 months follow-up. Following TAVR, MR improved in 34 patients (43%), remained stable in 38 (49%) and worsened in 6 (8%). Patients with MR improvement had greater tenting area (141 ± 56 vs. 99 ± 40 mm2 , P < 0.01), tenting height (7.2 ± 1.9 vs. 5.6 ± 1.9 mm, P < 0.01) and lower ejection fraction (43 ± 16 vs. 52 ± 14%, P = 0.01). MAC was frequent (87.7% of patients) and a trend in greater MAC was observed in patients without MR improvement (3560 ± 5587 vs. 2053 ± 2800, P = 0.16). In multivariable analysis, tenting area (OR per 10 mm2 increase: 1.012, 95% CI, 1.001-1.024 P = 0.039) and annulus calcifications associated with leaflet restriction (OR = 0.108, 95% CI, 0.012-0.956, P = 0.045) were independently associated with MR outcome after TAVR. CONCLUSION: Larger mitral valve tenting area was associated with more improvement of MR after TAVR whereas extensive MAC associated with leaflet restriction was associated with less improvement. This may help in the clinical decision-making process of TAVR candidates with concomitant MR.

Predictors and Association With Clinical Outcomes of the Changes in Exercise Capacity After Transcatheter Aortic Valve Replacement.

BACKGROUND: At present, there are no objective data specifically examining the clinical impact of variations in exercise capacity post-transcatheter aortic valve replacement (TAVR). We describe the changes in exercise capacity between baseline and 6 months post-TAVR, and ascertain factors associated with and clinical implications of a lack of improvement in exercise capacity post-TAVR. METHODS: A total of 305 patients (mean age, 79±9 years; 44% men; Society of Thoracic Surgeons predicted risk mortality score, 6.7±4.2%) undergoing TAVR completed both baseline and follow-up exercise capacity assessments at 6 months post-TAVR. Exercise capacity was evaluated by the 6-minute walk test (6MWT). Clinical outcomes were compared between patients displaying greater than (n=152; improving group) versus less than (n=153; nonimproving group) the median percentage change in distance walked between baseline and 6-month follow-up examinations. The primary outcome measure was clinical event rates, measured from the 6-month post-TAVR period onward. Further dichotomization according to baseline 6MWT distance (less than versus more than median walking distance, or slow walker versus fast walker) was also assessed. RESULTS: The mean overall distances walked pre- and post-TAVR (6 months post-TAVR) were 204±119 and 263±116 m, respectively (Δ6MWT=60±106 m), with 219 (72%) patients demonstrating an increase in their walking distance (median percentage increase of the entire population was 20% [interquartile range, 0%-80%]). Factors independently correlated with reduced exercise capacity improvement included a range of baseline clinical characteristics (older age, female sex, chronic obstructive pulmonary disease; P<0.05 for all), periprocedural major or life-threatening bleeding (P=0.009) and new-onset anemia at 6 months post-TAVR (P=0.009). Failure to improve the 6MWT distance by at least 20% was independently associated with all-cause mortality (P=0.002) and cardiovascular death or rehospitalization for cardiovascular causes (P=0.001). Baseline slow walkers who were able to improve the 6MWT distance presented with significantly better outcomes than nonimprovers (P=0.01 for all-cause mortality; P=0.001 for cardiovascular end point). CONCLUSIONS: Approximately one-third of patients undergoing TAVR did not improve their exercise capacity postprocedure. The lack of functional improvement post-TAVR was predicted by a mix of baseline and periprocedural factors translating into poorer clinical outcomes. These results suggest that systematically implementing exercise capacity assessment pre- and post-TAVR may help to improve patient risk stratification.

Infective endocarditis following transcatheter edge-to-edge mitral valve repair: A systematic review.

OBJECTIVES: To assess the clinical characteristics, management, and outcomes of patients diagnosed with infective endocarditis (IE) after edge-to-edge mitral valve repair with the MitraClip device. BACKGROUND: Transcatheter edge-to-edge mitral valve repair has emerged as an alternative to surgery in high-risk patients. However, few data exist on IE following transcatheter mitral procedures. METHODS: Four electronic databases (PubMed, Google Scholar, Embase, and Cochrane Library) were searched for original published studies on IE after edge-to-edge transcatheter mitral valve repair from 2003 to 2017. RESULTS: A total of 10 publications describing 12 patients with definitive IE (median age 76 years, 55% men) were found. The mean logistic EuroSCORE/EuroSCORE II were 41% and 45%, respectively. The IE episode occurred early (within 12 months post-procedure) in nine patients (75%; within the first month in five patients). Staphylococcus aureus was the most frequent (60%) causal microorganism, and severe mitral regurgitation was present in all cases but one. Surgical mitral valve replacement (SMVR) was performed in most (67%) patients, and the mortality associated with the IE episode was high (42%). CONCLUSIONS: IE following transcatheter edge-to-edge mitral valve repair is a rare but life-threatening complication, usually necessitating SMVR despite the high-risk profile of the patients. These results highlight the importance of adequate preventive measures and a prompt diagnosis and treatment of this serious complication.

Determination of the Clean Air Delivery Rate (CADR) of Photocatalytic Oxidation (PCO) Purifiers for Indoor Air Pollutants Using a Closed-Loop Reactor. Part I: Theoretical Considerations.

This study demonstrated that a laboratory-scale recirculation closed-loop reactor can be an efficient technique for the determination of the Clean Air Delivery Rate (CADR) of PhotoCatalytic Oxidation (PCO) air purification devices. The recirculation closed-loop reactor was modeled by associating equations related to two ideal reactors: one is a perfectly mixed reservoir and the other is a plug flow system corresponding to the PCO device itself. Based on the assumption that the ratio between the residence time in the PCO device and the residence time in the reservoir τP/τR tends to 0, the model highlights that a lab closed-loop reactor can be a suitable technique for the determination of the efficiency of PCO devices. Moreover, if the single-pass removal efficiency is lower than 5% of the treated flow rate, the decrease in the pollutant concentration over time can be characterized by a first-order decay model in which the time constant is proportional to the CADR. The limits of the model are examined and reported in terms of operating conditions (experiment duration, ratio of residence times, and flow rate ranges).

Determination of the Clean Air Delivery Rate (CADR) of Photocatalytic Oxidation (PCO) Purifiers for Indoor Air Pollutants Using a Closed-Loop Reactor. Part II: Experimental Results.

The performances of a laboratory PhotoCatalytic Oxidation (PCO) device were determined using a recirculation closed-loop pilot reactor. The closed-loop system was modeled by associating equations related to two ideal reactors: a perfectly mixed reservoir with a volume of VR = 0.42 m³ and a plug flow system corresponding to the PCO device with a volume of VP = 5.6 × 10-3 m³. The PCO device was composed of a pleated photocatalytic filter (1100 cm²) and two 18-W UVA fluorescent tubes. The Clean Air Delivery Rate (CADR) of the apparatus was measured under different operating conditions. The influence of three operating parameters was investigated: (i) light irradiance I from 0.10 to 2.0 mW·cm-2; (ii) air velocity v from 0.2 to 1.9 m·s-1; and (iii) initial toluene concentration C0 (200, 600, 1000 and 4700 ppbv). The results showed that the conditions needed to apply a first-order decay model to the experimental data (described in Part I) were fulfilled. The CADR values, ranging from 0.35 to 3.95 m³·h-1, were mainly dependent on the light irradiance intensity. A square root influence of the light irradiance was observed. Although the CADR of the PCO device inserted in the closed-loop reactor did not theoretically depend on the flow rate (see Part I), the experimental results did not enable the confirmation of this prediction. The initial concentration was also a parameter influencing the CADR, as well as the toluene degradation rate. The maximum degradation rate rmax ranged from 342 to 4894 ppbv/h. Finally, this study evidenced that a recirculation closed-loop pilot could be used to develop a reliable standard test method to assess the effectiveness of PCO devices.

Arrhythmia burden in elderly patients with severe aortic stenosis as determined by continuous electrocardiographic recording: toward a better understanding of arrhythmic events after transcatheter aortic valve replacement.

BACKGROUND: This study sought to evaluate the prevalence of previously undiagnosed arrhythmias in candidates for transcatheter aortic valve replacement (TAVR) and to determine the impact on therapy changes and arrhythmic events after the procedure. METHODS AND RESULTS: A total of 435 candidates for TAVR underwent 24-hour continuous ECG monitoring the day before the procedure. Newly diagnosed arrhythmias were observed in 70 patients (16.1%) before TAVR: paroxysmal atrial fibrillation (AF)/atrial tachycardia (AT) in 28, advanced atrioventricular block or severe bradycardia in 24, nonsustained ventricular tachycardia in 26, and intermittent left bundle-branch block in 3 patients. All arrhythmic events but one were asymptomatic and led to a therapy change in 43% of patients. In patients without known AF/AT, the occurrence of AF/AT during 24-hour ECG recording was associated with a higher rate of 30-day cerebrovascular events (7.1% versus 0.4%; P=0.030). Among the 53 patients with new-onset AF/AT after TAVR, 30.2% had newly diagnosed paroxysmal AF/AT before the procedure. In patients who needed permanent pacemaker implantation after the procedure (n=35), 31.4% had newly diagnosed advanced atrioventricular block or severe bradycardia before TAVR. New-onset persistent left bundle-branch block after TAVR occurred in 37 patients, 8.1% of whom had intermittent left bundle-branch block before the procedure. CONCLUSIONS: Newly diagnosed arrhythmias were observed in approximately a fifth of TAVR candidates, led to a higher rate of cerebrovascular events, and accounted for a third of arrhythmic events after the procedure. This high arrhythmia burden highlights the importance of an early diagnosis of arrhythmic events in such patients to implement the appropriate therapeutic measures earlier.

Infective endocarditis after transcatheter aortic valve implantation: results from a large multicenter registry.

BACKGROUND: We aimed to determine the incidence, predictors, clinical characteristics, management, and outcomes of infective endocarditis (IE) after transcatheter aortic valve implantation (TAVI). METHODS AND RESULTS: This multicenter registry included 53 patients (mean age, 79±8 years; men, 57%) who suffered IE after TAVI of 7944 patients after a mean follow-up of 1.1±1.2 years (incidence, 0.67%, 0.50% within the first year after TAVI). Mean time from TAVI was 6 months (interquartile range, 1-14 months). Orotracheal intubation (hazard ratio, 3.87; 95% confidence interval, 1.55-9.64; P=0.004) and the self-expandable CoreValve system (hazard ratio, 3.12; 95% confidence interval, 1.37-7.14; P=0.007) were associated with IE (multivariate analysis including 3067 patients with individual data). The most frequent causal microorganisms were coagulase-negative staphylococci (24%), followed by Staphylococcus aureus (21%) and enterococci (21%). Vegetations were present in 77% of patients (transcatheter valve leaflets, 39%; stent frame, 17%; mitral valve, 21%). At least 1 complication of IE occurred in 87% of patients (heart failure in 68%). However, only 11% of patients underwent valve intervention (valve explantation and valve-in-valve procedure in 4 and 2 patients, respectively). The mortality rate in hospital was 47.2% and increased to 66% at the 1-year follow-up. IE complications such as heart failure (P=0.037) and septic shock (P=0.002) were associated with increased in-hospital mortality. CONCLUSIONS: The incidence of IE at 1 year after TAVI was 0.50%, and the risk increased with the use of orotracheal intubation and a self-expandable valve system. Staphylococci and enterococci were the most common agents. Although most patients presented at least 1 complication of IE, valve intervention was performed in a minority of patients, and nearly half of the patients died during the hospitalization period.

Transcatheter mitral valve implantation for inoperable severely calcified native mitral valve disease: A systematic review.

BACKGROUND: Transcatheter mitral valve implantation (TMVI) for severely calcified native mitral valve disease recently emerged as a treatment option in patients deemed inoperable by conventional techniques. Yet no systematic appraisal currently exists characterizing this novel treatment paradigm. METHODS: A systematic literature review summarizing the clinical, anatomical, peri- and post-procedural characteristics underscoring the technical feasibility of this procedure was performed. RESULTS: Nine publications describing 11 patients [mean age 68 ± 10 years, 82% female, 82% severe mitral stenosis (MS), 18% severe mitral regurgitation (MR)] were identified. Mean STS score, trans-mitral gradient and effective orifice area were 10.5 ± 4.6%, 12 ± 2.4 mm Hg and 0.93 ± 0.06 cm(2) respectively. All patients had severe, circumferential mitral annular calcification on imaging. Dedicated balloon-expanding transcatheter aortic valves were used in 10/11 cases, with 8/11 cases involving a true percutaneous approach with peri-procedural 3D trans-esophageal echocardiographic guidance; 3/11 cases involved an open left atrial approach. Following initial balloon inflation and valve deployment, procedural success rate was 73%, without residual paravalvular leaks (PVL). Successful immediate re-deployment of a 2nd valve was needed in 2 instances following significant PVL detection. Residual trans-valvular gradients ranged from 3 to 7 mm Hg, with no patient demonstrating >grade 2 MR. All patients survived the procedure, with 2 reported deaths on days 10- and 41 post-TMVI being non-cardiac-related. Mid-term clinical follow-up, reported in 8 patients, revealed 6 patients to be alive at 3-months with much improved functional status. CONCLUSIONS: TMVI for native severely calcified mitral valve disease appears technically feasible with acceptable initial acute and mid-term hemodynamic and clinical outcomes. The outcomes of an ongoing, dedicated global Sapien TMVI registry will shed further light on this evolving treatment paradigm.

Embolic protection in patients undergoing transaortic transcatheter aortic valve replacement: initial experience with the TriGuard HDH embolic deflection device.

BACKGROUND: Stroke remains one of the most worrisome complications following transcatheter aortic valve replacement (TAVR). This pilot study evaluates the safety, feasibility, and exploratory efficacy of the TriGuard HDH embolic deflection device (Keystone Heart Ltd., Caesarea, Israel) in patients undergoing transaortic TAVR. METHODS: A total of 10 patients (median age: 81 years, STS score: 9.6 ± 5.6%) undergoing transaortic TAVR were included. All 30-day events were recorded and defined according to Valve Academic Research Consortium-2 criteria. Cerebral diffusion-weighted magnetic resonance imaging exams were planned preprocedure and within 10 days post-TAVR. The results of the magnetic resonances were analyzed in an independent core laboratory blinded to clinical data. Neurocognitive evaluation tests (Montreal Cognitive Assessment, Cogstate, Digit Symbol Substitution Test, Word Fluency Test, and Trailmaking tests) were performed at baseline, and within 10 and 30 days post-TAVR. RESULTS: The TriGuard HDH device was successfully deployed in all patients without complications. There was one procedural major vascular complication unrelated to the study device, and no clinically apparent stroke events were observed at 30-day follow-up. Cerebral diffusion weighted magnetic resonance imaging exams were performed in six patients at 7.5 ± 1.9 days post-TAVR showing the presence of new ischemic lesions in five patients (83.3%), which were single lesions in 60% of these individuals. Paired neurocognitive evaluation tests demonstrated no significant changes in neurocognitive parameters over time. CONCLUSIONS: This study shows the safety and feasibility of using the TriGuard HDH embolic protection device in transaortic TAVR. Further studies are warranted to determine the efficacy of embolic protection in this population.

Permanent pacemaker implantation after transcatheter aortic valve implantation: impact on late clinical outcomes and left ventricular function.

BACKGROUND: Very few data exist on the clinical impact of permanent pacemaker implantation (PPI) after transcatheter aortic valve implantation. The objective of this study was to assess the impact of PPI after transcatheter aortic valve implantation on late outcomes in a large cohort of patients. METHODS AND RESULTS: A total of 1556 consecutive patients without prior PPI undergoing transcatheter aortic valve implantation were included. Of them, 239 patients (15.4%) required a PPI within the first 30 days after transcatheter aortic valve implantation. At a mean follow-up of 22±17 months, no association was observed between the need for 30-day PPI and all-cause mortality (hazard ratio, 0.98; 95% confidence interval, 0.74-1.30; P=0.871), cardiovascular mortality (hazard ratio, 0.81; 95% confidence interval, 0.56-1.17; P=0.270), and all-cause mortality or rehospitalization for heart failure (hazard ratio, 1.00; 95% confidence interval, 0.77-1.30; P=0.980). A lower rate of unexpected (sudden or unknown) death was observed in patients with PPI (hazard ratio, 0.31; 95% confidence interval, 0.11-0.85; P=0.023). Patients with new PPI showed a poorer evolution of left ventricular ejection fraction over time (P=0.017), and new PPI was an independent predictor of left ventricular ejection fraction decrease at the 6- to 12-month follow-up (estimated coefficient, -2.26; 95% confidence interval, -4.07 to -0.44; P=0.013; R(2)=0.121). CONCLUSIONS: The need for PPI was a frequent complication of transcatheter aortic valve implantation, but it was not associated with any increase in overall or cardiovascular death or rehospitalization for heart failure after a mean follow-up of ≈2 years. Indeed, 30-day PPI was a protective factor for the occurrence of unexpected (sudden or unknown) death. However, new PPI did have a negative effect on left ventricular function over time.