Extent of cardiac damage and hospitalization burden in patients undergoing transcatheter aortic valve replacement.

BACKGROUND: Cardiac damage has gained increasing attention as a valid prognostic marker of mortality after transcatheter aortic valve replacement (TAVR). However, studies investigating the possible association between cardiac damage and hospitalization burden in TAVR patients are lacking. AIMS: This study aimed to investigate the impact of baseline cardiac damage on the hospitalization burden before, during, and after TAVR in an all-comers population. METHODS: All consecutive patients who underwent TAVR between 2016 and 2020 were included. Electronic medical records of all patients were examined to validate cardiovascular (CV) and heart failure (HF) related hospitalizations from 6 months before to 1 year after TAVR. Baseline cardiac damage was defined according to the staging classification by Généreux et al. RESULTS: Among 1397 TAVR patients, 94 (6.7%) had stage 0, 368 (26.4%) stage 1, 736 (52.7%) stage 2, 115 (8.2%) stage 3, and 84 (6.0%) stage 4 cardiac damage. Patients with more advanced cardiac damage at baseline had more HF hospitalizations within 6 months before TAVR (p < 0.01) and with a longer length of stay (LoS) (p < 0.01). Regarding the index TAVR admission, there was no difference in procedure time (p = 0.26) or LoS (p = 0.18) between groups. Still, TAVR patients with more advanced baseline cardiac damage had a higher risk of CV and HF rehospitalization after TAVR (p < 0.05). CONCLUSIONS: Baseline cardiac damage in patients undergoing TAVR has an impact on the pre- and post-procedural cardiovascular hospitalization burden. However, the cardiac damage status does not affect the TAVR procedure time or index TAVR admission length of stay.

Impact of Mitral Regurgitation Etiology on Mitral Surgery After Transcatheter Edge-to-Edge Repair: From the CUTTING-EDGE Registry.

BACKGROUND: Although >150,000 mitral TEER procedures have been performed worldwide, the impact of MR etiology on MV surgery after TEER remains unknown. OBJECTIVES: The authors sought to compare outcomes of mitral valve (MV) surgery after failed transcatheter edge-to-edge repair (TEER) stratified by mitral regurgitation (MR) etiology. METHODS: Data from the CUTTING-EDGE registry were retrospectively analyzed. Surgeries were stratified by MR etiology: primary (PMR) and secondary (SMR). MVARC (Mitral Valve Academic Research Consortium) outcomes at 30 days and 1 year were evaluated. Median follow-up was 9.1 months (IQR: 1.1-25.8 months) after surgery. RESULTS: From July 2009 to July 2020, 330 patients underwent MV surgery after TEER, of which 47% had PMR and 53.0% had SMR. Mean age was 73.8 ± 10.1 years, median STS risk at initial TEER was 4.0% (IQR: 2.2%-7.3%). Compared with PMR, SMR had a higher EuroSCORE, more comorbidities, lower LVEF pre-TEER and presurgery (all P < 0.05). SMR patients had more aborted TEER (25.7% vs 16.3%; P = 0.043), more surgery for mitral stenosis after TEER (19.4% vs 9.0%; P = 0.008), and fewer MV repairs (4.0% vs 11.0%; P = 0.019). Thirty-day mortality was numerically higher in SMR (20.4% vs 12.7%; P = 0.072), with an observed-to-expected ratio of 3.6 (95% CI: 1.9-5.3) overall, 2.6 (95% CI: 1.2-4.0) in PMR, and 4.6 (95% CI: 2.6-6.6) in SMR. SMR had significantly higher 1-year mortality (38.3% vs 23.2%; P = 0.019). On Kaplan-Meier analysis, the actuarial estimates of cumulative survival were significantly lower in SMR at 1 and 3 years. CONCLUSIONS: The risk of MV surgery after TEER is nontrivial, with higher mortality after surgery, especially in SMR patients. These findings provide valuable data for further research to improve these outcomes.

Diabetes mellitus in transfemoral transcatheter aortic valve implantation: a propensity matched analysis.

BACKGROUND: Diabetes Mellitus (DM) affects a third of patients with symptomatic severe aortic valve stenosis undergoing transcatheter aortic valve implantation (TAVI). DM is a well-known risk factor for cardiac surgery, but its prognostic impact in TAVI patients remains controversial. This study aimed to evaluate outcomes in diabetic patients undergoing TAVI. METHODS: This multicentre registry includes data of > 12,000 patients undergoing transfemoral TAVI. We assessed baseline patient characteristics and clinical outcomes in patients with DM and without DM. Clinical outcomes were defined by the second valve academic research consortium. Propensity score matching was applied to minimize potential confounding. RESULTS: Of the 11,440 patients included, 31% (n = 3550) had DM and 69% (n = 7890) did not have DM. Diabetic patients were younger but had an overall worse cardiovascular risk profile than non-diabetic patients. All-cause mortality rates were comparable at 30 days (4.5% vs. 4.9%, RR 0.9, 95%CI 0.8-1.1, p = 0.43) and at one year (17.5% vs. 17.4%, RR 1.0, 95%CI 0.9-1.1, p = 0.86) in the unmatched population. Propensity score matching obtained 3281 patient-pairs. Also in the matched population, mortality rates were comparable at 30 days (4.7% vs. 4.3%, RR 1.1, 95%CI 0.9-1.4, p = 0.38) and one year (17.3% vs. 16.2%, RR 1.1, 95%CI 0.9-1.2, p = 0.37). Other clinical outcomes including stroke, major bleeding, myocardial infarction and permanent pacemaker implantation, were comparable between patients with DM and without DM. Insulin treated diabetics (n = 314) showed a trend to higher mortality compared with non-insulin treated diabetics (n = 701, Hazard Ratio 1.5, 95%CI 0.9-2.3, p = 0.08). EuroSCORE II was the most accurate risk score and underestimated 30-day mortality with an observed-expected ratio of 1.15 in DM patients, STS-PROM overestimated actual mortality with a ratio of 0.77 and Logistic EuroSCORE with 0.35. CONCLUSION: DM was not associated with mortality during the first year after TAVI. DM patients undergoing TAVI had low rates of mortality and other adverse clinical outcomes, comparable to non-DM TAVI patients. Our results underscore the safety of TAVI treatment in DM patients. TRIAL REGISTRATION: The study is registered at clinicaltrials.gov (NCT03588247).

Outcomes in Valve-in-Valve Transcatheter Aortic Valve Implantation.

The use of valve-in-valve transcatheter aortic valve implantation (ViV-TAVI) is increasing, but studies evaluating clinical outcomes in these patients are scarce. Also, there are limited data to guide the choice of valve type in ViV-TAVI. Therefore, this CENTER-study evaluated clinical outcomes in patients with ViV-TAVI compared to patients with native valve TAVI (NV-TAVI). In addition, we compared outcomes in patients with ViV-TAVI treated with self-expandable versus balloon-expandable valves. A total of 256 patients with ViV-TAVI and 11333 patients with NV-TAVI were matched 1:2 using propensity score matching, resulting in 256 patients with ViV-TAVI and 512 patients with NV-TAVI. Mean age was 81±7 years, 58% were female, and the Society of Thoracic Surgeons Predicted Risk of Mortality was 6.3% (4.0% to 12.8%). Mortality rates were comparable between ViV-TAVI and NV-TAVI patients at 30 days (4.1% vs 5.9%, p = 0.30) and 1 year (14.2% vs 17.3%, p = 0.34). Stroke rates were also similar at 30 days (2.8% vs 1.8%, p = 0.38) and 1 year (4.9% vs 4.3%, p = 0.74). Permanent pacemakers were less frequently implanted in patients with ViV-TAVI (8.8% vs 15.0%, relative risk 0.59, 95% confidence interval [CI] 0.37 to 0.92, p = 0.02). Patients with ViV-TAVI were treated with self-expandable valves (n = 162) and balloon-expandable valves (n = 94). Thirty-day major bleeding was less frequent in patients with self-expandable valves (3% vs 13%, odds ratio 5.12, 95% CI 1.42 to 18.52, p = 0.01). Thirty-day mortality was numerically lower in patients with self-expandable valves (3% vs 7%, odds ratio 3.35, 95% CI 0.77 to 14.51, p = 0.11). In conclusion, ViV-TAVI seems a safe and effective treatment for failing bioprosthetic valves with low mortality and stroke rates comparable to NV-TAVI for both valve types.

Balloon-Expandable versus Self-Expandable Valves in Transcatheter Aortic Valve Implantation: Complications and Outcomes from a Large International Patient Cohort.

BACKGROUND: Both balloon-expandable (BE) and self-expandable (SE) valves for transcatheter aortic valve implantation (TAVI) are broadly used in clinical practice. However, adequately powered randomized controlled trials comparing these two valve designs are lacking. METHODS: The CENTER-study included 12,381 patients undergoing transfemoral TAVI. Patients undergoing TAVI with a BE-valve (n = 4096) were compared to patients undergoing TAVI with an SE-valve (n = 4096) after propensity score matching. Clinical outcomes including one-year mortality and stroke rates were assessed. RESULTS: In the matched population of n = 5410 patients, the mean age was 81 ± 3 years, 60% was female, and the STS-PROM predicted 30-day mortality was 6.2% (IQR 4.0-12.4). One-year mortality was not different between patients treated with BE- or SE-valves (BE: 16.4% vs. SE: 17.0%, Relative Risk 1.04, 95%CI 0.02-1.21, p = 0.57). One-year stroke rates were also comparable (BE: 4.9% vs. SE: 5.3%, RR 1.09, 95%CI 0.86-1.37, p = 0.48). CONCLUSION: This study suggests that one-year mortality and stroke rates were comparable in patients with severe aortic valve stenosis undergoing TAVI with either BE or SE-valves.

Balloon-expandable or self-expandable valves in valve-in valve transcatheter aortic valve implantation?

BACKGROUND Bioprosthetic valves are increasingly implanted in patients with aortic valve stenosis. These valves have a limited durability. Valve-in-valve (ViV) transcatheter aortic valve implanta tion (TAVI) is a treatment option for bioprosthetic valve failure. Both balloon-expandable (BE) and self-expandable (SE) valves are widely used in ViV-TAVI procedures. However, studies comparing outcomes between these fundamentally different valve designs in ViV-TAVI are lacking. METHODS The CENTER study is a patient pooled analysis, comprising data of 12,381 patients undergoing transfemoral TAVI in 6 countries. We assessed differences in clinical outcomes between SE and BE valves in ViV-TAVI patients, as defined by the Valve Academic Research Consortium. RESULTS A total of 256 patients were treated with transfemoral ViV TAVI. Of these, 50% were female, median age was 82 (IQR: 78-85) years, and median STS-PROM was 6.3% (IQR: 4.0%-10.4%). SE valves were used in 162 patients (63%) and BE valves in 94 (37%) patients. SE and BE valve recipients were similar regarding female sex (53% vs 47%; P » 0.38), age (82 years [78-85] vs 81 [78-84]; P » 0.24), and STS PROM (6.5% [4.2%-10.2%] vs 6.2% [4.0%-10.9%]; P » 1.00). Third generation valves were used in 91 (56%) of SE valves and in 40 (43%) of BE valves. There was a trend towards lower 30-day mortality in SE valve patients (3% vs 7%; RR: 0.37; 95% CI: 0.11-1.26; P » 0.10). In addition, 30-day major bleeding was less frequent in SE valve patients (3% vs 13%; RR: 0.27; 95% CI: 0.09-0.79; P » 0.01). Rates of conversion to surgery (1% vs 0; P » 0.44) and device success were similar (90% vs 92%; P » 0.62). Moreover, 30-day rates of stroke (1.9% vs 4.6%; P » 0.22), myocardial infarction (0.7% vs 1.8%; P » 0.46), and permanent pacemaker implantation (9.3% vs 7.9%; P » 0.70) were similar. There was no difference in 1-year mortality (12.5% vs 17.6%; P » 0.32) and stroke rates (3.7% vs 7.4%; P » 0.25). CONCLUSION There was a trend toward lower 30-day mortality in ViV-TAVI patients treated with SE valves. Moreover, the use of SE valves in ViV-TAVI was associated with lower rates of major bleeding than BE valves. Our findings warrant randomized controlled trials directly comparing SE and BE valves in ViV-TAVI patients.

Atrial fibrillation in patients undergoing transcatheter aortic valve implantation is associated with increased mortality

BACKGROUND Atrial fibrillation (AF) is common in patients with aortic valve stenosis undergoing transcatheter aortic valve implanta tion (TAVI). We compared clinical outcomes between TAVI patients with baseline AF versus TAVI patients without AF. METHODS The CENTER study is an international collaboration including 12,381 patients treated with transfemoral TAVI. This pooled analysis consists of patient level data from 10 different studies. End points were stroke and mortality rates at 30 days and 1 year after TAVI as defined by the Valve Academic Research Consortium. RESULTS Of the 12,381 patients, 58% were female, the mean age was 81.5 7.0 years, and the median logistic EuroSCORE was 14.4% (9.0%- 23.0%). A total of 3,354 patients (27%) had known baseline AF. In patients with AF, there was a trend toward higher in-hospital mor tality (5.3% vs 3.5%; relative risk [RR]: 1.18; 95% confidence interval [CI]: 0.99-1.41; P » 0.06). Moreover, 30-day mortality (7.1% vs 5.3%; RR: 1.35; 95% CI: 1.16-1.59; P < 0.001) as well as 1-year mortality (20.8% vs 15.3%; RR: 1.35; 95% CI: 1.23-1.52; P < 0.001) was higher in AF patients. In contrast, stroke rates were comparable in patients with versus without AF during hospital admission (2.2% vs 2.0%, P » 0.60), at 30 days (2.9% vs 2.4%, P » 0.18), and 1 year after TAVI (5.3% vs 5.1%, P » 0.75). Also, 30-day rates of myocardial infarction (0.8% vs 1.0%, P » 0.38) and major bleeding (7.6% vs 7.3%, P » 0.53) were similar between both patient groups. However, permanent pace makers were more frequently implanted in AF patients (14.8% vs 13.4%; RR: 1.11; 95% CI: 1.00-1.23; P » 0.05). CONCLUSION In this global study of >12,000 patients undergoing transfemoral TAVI, AF was associated with higher 30-day and 1-year mortality. Moreover, patients with AF more frequently required a permanent pacemaker. Although AF is a common condition in pa tients undergoing TAVI, it is undoubtedly not a benign arrhythmia. Therefore, our results underscore the evident need for further research in treatment options for patients with AF undergoing TAVI.

Suture- or Plug-Based Large-Bore Arteriotomy Closure: A Pilot Randomized Controlled Trial.

OBJECTIVES: This study sought to test the superiority in terms of efficacy and safety of a dedicated plug-based vascular closure device (VCD) during transcatheter aortic valve replacement (TAVR) over a suture-based VCD. BACKGROUND: Vascular complications after TAVR are relevant and often associated with VCD failure. METHODS: The MASH (MANTA vs. Suture-based vascular closure after transcatHeter aortic valve replacement) trial is an international, 2-center pilot randomized controlled trial comparing the MANTA VCD (Teleflex, Wayne, Pennsylvania) versus 2 ProGlides (Abbott Vascular, Abbott Park, Illinois). The primary composite endpoint consisted of access site-related major or minor vascular complications at 30-days' follow-up. Secondary endpoints included clinically relevant access site bleeding, time to hemostasis, and modified VCD failure (defined as failure to achieve hemostasis within 5 min or requiring additional endovascular maneuvers such as endovascular stenting, surgical techniques, or additional closure devices). Adverse events were adjudicated by an independent clinical events committee according to the VARC-2 definitions. RESULTS: A total of 210 TAVR patients were included between October 2018 and January 2020. Median age was 81 years, 54% were male, and the median STS score was 2.7%. There was no significant difference in the primary endpoint of access site-related vascular complications between MANTA and ProGlide (10% vs. 4%; p = 0.16). Clinically significant access site bleedings were similar with both closure techniques (9% vs. 6%; p = 0.57). Modified VCD failure occurred less frequently in MANTA versus ProGlide (20% vs. 40%; p < 0.01). Suture-based closure required more often additional closure devices, whereas MANTA numerically needed more covered stents and surgical bailouts. CONCLUSIONS: Plug-based large-bore arteriotomy closure was not superior to suture-based closure. Plug-based closure required fewer, but a different kind of bailout maneuvers.

Dislodged Coronary Artery Stent Retrieved With an Endovascular Snare.

Advances in stent design and technology have made stent loss during percutaneous coronary intervention rare. When stent loss occurs, the risk of life-threatening procedural complications is high. We describe the use of an endovascular snare system to retrieve a dislodged stent from the proximal right coronary artery of a 54-year-old man during percutaneous coronary intervention after other conventional retrieval techniques had failed.

Monocytes in coronary artery disease and atherosclerosis: where are we now?

Despite improvements in interventional and pharmacological therapy of atherosclerotic disease, it is still the leading cause of death in the developed world. Hence, there is a need for further development of effective therapeutic approaches. This requires better understanding of the molecular mechanisms and pathophysiology of the disease. Atherosclerosis has long been identified as having an inflammatory component contributing to its pathogenesis, whereas the available therapy primarily targets hyperlipidemia and prevention of thrombosis. Notwithstanding a pleotropic anti-inflammatory effect to some therapies, such as acetyl salicylic acid and the statins, none of the currently approved medicines for management of either stable or complicated atherosclerosis has inflammation as a primary target. Monocytes, as representatives of the innate immune system, play a major role in the initiation, propagation, and progression of atherosclerosis from a stable to an unstable state. Experimental data support a role of monocytes in acute coronary syndromes and in outcome post-infarction; however, limited research has been done in humans. Analysis of expression of various cell surface receptors allows characterization of the different monocyte subsets phenotypically, whereas downstream assessment of inflammatory pathways provides an insight into their activity. In this review we discuss the functional role of monocytes and their different subpopulations in atherosclerosis, acute coronary syndromes, cardiac healing, and recovery with an aim of critical evaluation of potential future therapeutic targets in atherosclerosis and its complications. We will also discuss technical difficulties of delineating different monocyte subpopulations, understanding their differentiation potential and function.

The effects of exercise and diurnal variation on monocyte subsets and monocyte-platelet aggregates.

BACKGROUND: Monocytes are important mediators in the pathophysiology of cardiovascular disease, but only scarce data are available on biological and methodological factors affecting their levels. DESIGN: Three monocyte subsets, CD14(++) CD16(-) CCR2+ (Mon1), CD14(++) CD16(+) CCR2(+) (Mon2), CD14(+) CD16(+) CCR2(-) (Mon3), and monocyte-platelet aggregates (MPAs) were analysed by flow cytometry. The effects of treadmill exercise were assessed on 12 healthy volunteers. Diurnal variation was evaluated in 16 healthy volunteers, and the effects of delayed blood processing were measured in 12 samples. RESULTS: Mon1 were increased when measured 15 min after exercise followed by a reduction at 1 h (P < 0·05 for both). MPAs were significantly reduced at 15 min and 1 h (P < 0·05 for both). There was significant diurnal variation in the numbers of Mon2, which were highest at 6 pm and lowest at 6 am. There were also significant diurnal variations in phagocytic activity of Mon1 and Mon2, which were highest at 12 pm and lowest at 12 am. Monocyte counts remained stable up to 2 h after venipuncture. MPAs were significantly increased at 2 h and increased further by 4 h after sampling. CONCLUSIONS: Monocyte subset Mon2 and monocyte phagocytic activity undergo significant diurnal variation. A single bout of exercise causes a temporal increase in monocytes and a reduction in MPAs. Monocyte subset counts should be analysed within 2 h of blood sampling, whereas measurement of MPAs and monocyte CD14 and CD16 expression should be performed within 1 h.

Sudden death is less common than might be expected in underprivileged ethnic minorities at high cardiovascular risk.

UNLABELLED: Sudden cardiac death can be the presenting feature of coronary disease. Limited epidemiological studies from the US suggest an increased prevalence of sudden death in the African-American community. There are no reports in UK minority communities. We present sudden death data from an area with a high density of underprivileged ethnic minority groups. METHODS: Ambulance data forms and accident and emergency records of all sudden unexpected deaths bought to City Hospital Birmingham in 2002 were extracted by retrospective review. The clinical characteristics and timing of the events were defined and analysed on the basis of the ethnic origins of the victims. RESULTS: The prevalence of sudden death amongst Caucasians was substantially greater than among minorities. Both Indo-Asians and Afro-Caribbean groups had a lower than expected sudden death rate. Caucasian patients more commonly demonstrated a ventricular fibrillation (VF) rhythm at presentation while Indo-Asians and Afro-Caribbean's demonstrated a non-VF rhythm (asystole and pulseless electrical activity (PEA). Collapse with syncope was more common in Afro-Caribbean subjects while Indo-Asian subjects more often arrested in transit. There were no differences in call or transfer times. CONCLUSIONS: Despite a well-described pattern of more aggressive coronary disease, particularly noted in South Asian communities in the UK, the sudden death rate are not increased and may be decreased. This implies a potentially separate mechanism or a confounding cultural influence in these events.