Efficacy of intravascular lithotripsy (IVL) in coronary stenosis with severe calcification: A multicenter systematic review and meta-analysis.

BACKGROUND: With heavily calcified coronary and peripheral artery lesions, lesion preparation is crucial before stent placement to avoid underexpansion, associated with stent thrombosis or restenosis and patency failure in the long-term. Intravascular lithotripsy (IVL) technology disrupts superficial and deep calcium by using localized pulsative sonic pressure waves, making it to a promising tool for patients with severe calcification in coronary bed. AIMS: The aim of the study is to systematically review and summarize available data regarding the safety and efficacy of IVL for lesion preparation in severely calcified coronary arteries before stenting. METHODS: This study was conducted according to the PRISMA guidelines. We systematically searched PubMed, SCOPUS, and Cochrane databases from their inception to February 23, 2023, for studies assessing the characteristics and outcomes of patients undergoing IVL before stent implantation. The diameter of the vessel lumen before and after IVL, as well as stent implantation, were analyzed. The occurrence of major adverse cardiovascular events (MACE) was assessed using a random-effects model. RESULTS: This meta-analysis comprised 38 studies including 2977 patients with heavily calcified coronary lesions. The mean age was 72.2 ± 9.1 years, with an overall IVL clinical success of 93% (95% confidence interval [CI]: 91%-95%, I2 = 0%) and procedural success rate of 97% (95% CI: 95%-98%, I2 = 73.7%), while the in-hospital and 30-days incidence of MACE, myocardial infarction (MI), and death were 8% (95% CI: 6%-11%, I2 = 84.5%), 5% (95% CI: 2%-8%, I2 = 85.6%), and 2% (95% CI: 1%-3%, I2 = 69.3%), respectively. There was a significant increase in the vessel diameter (standardized mean difference [SMD]: 2.47, 95% CI: 1.77-3.17, I2 = 96%) and a decrease in diameter stenosis (SMD: -3.44, 95% CI: -4.36 to -2.52, I2 = 97.5%) immediately after IVL application, while it was observed further reduction in diameter stenosis (SMD: -6.57, 95% CI: -7.43 to -5.72, I2 = 95.8%) and increase in the vessel diameter (SMD: 4.37, 95% CI: 3.63-5.12, I2 = 96.7%) and the calculated lumen area (SMD: 3.23, 95% CI: 2.10-4.37, I2 = 98%), after stent implantation. The mean acute luminal gain following IVL and stent implantation was estimated to be 1.27 ± 0.6 and 1.94 ± 1.1 mm, respectively. Periprocedural complications were rare, with just a few cases of perforations, dissection, or no-reflow phenomena recorded. CONCLUSIONS: IVL seems to be a safe and effective strategy for lesion preparation in severely calcified lesions before stent implantation in coronary arteries. Future prospective studies are now warranted to compare IVL to other lesion preparation strategies.

Transmission of Infections during Cardiopulmonary Resuscitation.

Cardiopulmonary resuscitation (CPR) is an emergency lifesaving endeavor, performed in either the hospital or outpatient settings, that significantly improves outcomes and survival rates when performed in a timely fashion. As with any other medical procedure, CPR can bear potential risks not only for the patient but also for the rescuer. Among those risks, transmission of an infectious agent has been one of the most compelling triggers of reluctance to perform CPR among providers. The concern for transmission of an infection from the resuscitated subject may impede prompt initiation and implementation of CPR, compromising survival rates and neurological outcomes of the patients. Infections during CPR can be potentially acquired through airborne, droplet, contact, or hematogenous transmission. However, only a few cases of infection transmission have been actually reported globally. In this review, we present the available epidemiological findings on transmission of different pathogens during CPR and data on reluctance of health care workers to perform CPR. We also outline the levels of personal protective equipment and other protective measures according to potential infectious hazards that providers are potentially exposed to during CPR and summarize current guidelines on protection of CPR providers from international societies and stakeholders.

Transcatheter mitral valve-in-valve replacement transeptally using a novel balloon-expandable device.

We describe a patient with symptomatic severe mitral regurgitation, due to a failed 33-mm Epic (St. Jude Medical, St. Paul, MN) bioprosthetic heart valve surgically implanted 10-year before. For this specific purpose, we implanted a novel balloon-expandable transcatheter heart valve, the MyVal (Meril Life Science, Vapi, India). To the best of our knowledge, this is the second case describing the implantation of MyVal in a degenerative, surgically placed bioprosthesis.

Long-term clinical outcomes of coronary artery bypass graft surgery compared to those of percutaneous coronary intervention with second generation drug eluting stents in patients with stable angina and an isolated lesion in the proximal left anterior descending artery.

OBJECTIVES: We compared the long-term outcomes of percutaneous coronary intervention with second-generation drug-eluting stents (PCI-DES) and coronary artery bypass graft surgery (CABG) with the left internal mammary artery in stable angina patients with isolated single-vessel proximal left anterior descending artery (pLAD) disease. BACKGROUND: Long-term outcomes of second-generation PCI-DES and CABG in isolated pLAD lesions have not been extensively studied. METHODS: We included 631 PCI-DES patients and 379 CABG patients. Unadjusted and adjusted hazard ratios (HRs) were derived for major adverse cardiac events (MACEs), their components (cardiac death, nonfatal myocardial infarction [MI] not attributed to a non-target vessel, target-lesion revascularization), and patient-related outcome (PRO, composed of all-cause mortality, any MI, any revascularization). RESULTS: In the unadjusted and adjusted analyses, no significant difference was observed between the two groups at follow-up (mean:4.6 ± 2.5 years) for MACEs (HR: 1.45, 95% CI: 0.92-2.28, p = .11; HR:1.43, 95% CI: 0.91-2.26, p = .13), PRO (HR: 1.18, 95%CI: 0.86-1.61, p = .30; HR: 1.18, 95% CI: 0.86-1.62, p = .31), cardiac death (HR: 0.97, 95% CI: 0.46-2.05, p = .93; HR: 0.79, 95% CI: 0.36-1.72, p = .56) and MI (HR: 1.43, 95% CI: 0.49-4.13, p = .51; HR: 1.57, 95% CI: 0.53-4.64, p = .42). Compared with CABG, PCI-DES had a borderline significantly greater risk of repeat revascularization (HR: 1.99, 95% CI: 1.00-3.94, p = .05; HR: 1.95, 95% CI: 0.98-3.9, p = .06). Angina recurred more often after PCI (p < .001), whereas more arrhythmias developed after CABG (p = .02). PCI-DES resulted in fewer in-hospital complications (p < .001) and shorter hospitalizations (p < .001). CONCLUSIONS: The long-term clinical outcomes of second-generation PCI-DES and CABG in patients with stable angina and isolated pLAD disease were comparable.

One-year clinical and echocardiographic outcomes of direct implantation of a self-expanding valve.

OBJECTIVE: To present 1 year clinical and echocardiographic outcomes of the randomized DIRECT (Pre-dilatation in Transcatheter Aortic Valve Implantation Trial) trial. BACKGROUND: Intermediate-term data from randomized studies investigating the safety and efficacy of direct implantation are lacking. METHODS: DIRECT trial randomized 171 consecutive patients with severe aortic stenosis at four tertiary centers to undergo TAVI with the use of self-expanding prostheses with (pre-BAV) or without pre-dilatation (no-BAV). The primary endpoint was device success according to the VARC-2 criteria. All patients underwent a clinical and echocardiographic follow-up at 1 year. All-cause and cardiac mortality, stroke, heart failure hospitalization, and new pacemaker implantation were recorded. RESULTS: At 1 year, four deaths were recorded in pre-BAV group (4.7%) and three deaths in no-BAV group (3.5%). There was no difference in Kaplan-Meier plots between the two groups in all-cause mortality at 1 year (log-rank p = .72). Similarly, there was no difference in the incidence of permanent pacemaker implantation between the two groups at 1 year (27/67-40.3% in no-BAV group versus 20/69-29% in pre-BAV group, log-rank p = .24). There was no significant difference between pre-BAV and no BAV group in aortic valve area (1.84 ± 0.39 cm2 vs. 1.85 ± 0.44 cm2 , p = .90), mean aortic valve gradient (8.36 ± 5.04 vs. 8.00 ± 4.04 mmHg, p = .65) and moderate or severe paravalvular regurgitation (5-6.6 vs. 4-5.7%, respectively) at 1 year. The same applied independently from the performance of post-dilatation at baseline. CONCLUSIONS: Direct, without pre-dilatation, implantation of a self-expanding valve has no impact on one-year clinical and echocardiographic outcomes, independently also from the baseline performance of post-dilatation.

The requirement of extracorporeal circulation system for transluminal aortic valve replacement: Do we really need it in the catheterization laboratory?

Transcatheter aortic valve replacement (TAVR) is the mainstay for treating high-risk patients with aortic stenosis. As the TAVR procedures worldwide keep increasing, it is inevitable that more issues and complications will arise. Such a complication that merits attention is the conversion of TAVR into open-heart surgery and the necessity this complication creates to have an extracorporeal circulation system in the catheterization laboratory. This review contains an analysis of all major randomized trials and registries on the number and cause of TAVR procedures that ended up in open-heart surgery and presents data to challenge the prerequisite of extracorporeal circulation system in the cath laboratory. © 2015 Wiley Periodicals, Inc.

Expression of Lectin-Like Oxidized Low-Density Lipoprotein Receptor-1 in Human Epicardial and Intramyocardial Coronary Arteries of Male Patients Undergoing Coronary Artery Bypass Grafting.

OBJECTIVES: Atherosclerosis is almost absent in intramyocardial coronary arteries, while epicardial coronary arteries may show extensive occlusive disease. Lectin-like oxidized low-density lipoprotein receptor-1 (LOX-1) expression has been implicated in atherogenesis. We aimed to investigate differences in arterial wall LOX-1 expression between human epicardial and intramyocardial coronary arteries. METHODS: Epicardial and intramyocardial total artery wall specimens were obtained from 13 male patients (aged 61.9 ± 10.3 years) undergoing coronary artery bypass graft surgery due to 3-vessel coronary artery disease. LOX-1 expression was examined by reverse transcription-polymerase chain reaction. RESULTS: LOX-1 expression was significantly higher in the arterial wall of epicardial coronary arteries compared to intramyocardial coronary arteries. The LOX-1/GAPDH ratio was 0.48 ± 0.07 vs. 0.35 ± 0.03 (p < 0.001). CONCLUSIONS: Our findings may partially explain the atheroprotective effect of the intramyocardial course since arterial wall LOX-1 expression was lower in intramyocardial arteries and higher in epicardial coronary arteries.

Anesthetic ointment only (lidocaine/prilocaine) instead of injectable local lidocaine in trans-radial catheterization: A viable no-needle alternative.

OBJECTIVE: The aim of the present study was to assess the level of access site pain in patients undergoing transradial coronary catheterization by using topical application of an anesthetic ointment (lidocaine/prilocaine-AO) compared to standard local anesthesia (LA) by means of injectable lidocaine. METHODS: We prospectively studied 444 patients undergoing elective trans-radial coronary angiography. The quality of analgesia was assessed using a visual analogue scale (VAS) immediately after the puncture and 30 min after the removal of the sheath. The number and duration of attempts before successful sheath insertion, as well as artery spasm, were compared between the two groups. RESULTS: Pain levels measured by VAS were found to be similar between the two groups during sheath insertion (VAS: AO: 4.84 ± 1.0 vs 4.82 ± 1.2, P = NS), as well as 30 min after sheath removal (VAS: AO: 0.07 ± 0.5 vs LA: 0.15 ± 0.6, P = NS). The time to obtain radial access was also not affected by the use of anesthetic ointment (AO: 62.24 ± 25.7 s vs LA: 64.04 ± 18.78 sec, P = NS). The rate of clinical or angiographic radial artery spasm was similar (8-10%) between the groups (P = NS) CONCLUSION: Use of a local anesthetic ointment, versus injectable lidocaine, in trans-radial cardiac catheterization as means of local anesthesia, was found to be equally effective in terms of pain, artery spasm, or artery cannulation speed.

Sustained ventricular tachycardia as a first manifestation of hypertrophic cardiomyopathy with mid-ventricular obstruction and apical aneurysm in an elderly female patient.

Sustained ventricular tachycardia complicating left ventricular apical aneurysms has been reported previously solely in middle-aged patients with hypertrophic cardiomyopathy and mid-cavity obstruction. We report a case of an elderly female patient who presented with incessant ventricular tachycardia as the first clinical manifestation of hypertrophic cardiomyopathy with mid-ventricular obstruction and apical aneurysm.

Outcomes of Same Day Pacemaker Implantation after TAVI.

BACKGROUND: Transcatheter aortic valve implantation (TAVI) is often associated with conduction disturbances, followed by permanent pacemaker (PPM) implantation. Because of the potential reversibility of these conduction disorders, controversy exists regarding the right timing of PPM implantation. TAVI is routinely performed under dual-antiplatelet and antithrombotic therapy, which poses an additional hemorrhagic risk on a same-day procedure. The aim of the present study was to evaluate the safety and effectiveness of same-day PPM implantation in patients undergoing TAVI. METHODS: Consecutive patients undergoing TAVI with Medtronic Corevalve bioprosthesis (Medtronic Inc., Minneapolis, MN, USA) in a tertiary center were divided into two study groups. Group A included patients undergoing PPM implantation the same day with TAVI, and Group B patients were implanted with a PPM later after TAVI and before hospital discharge. The two study groups were compared for all complications associated with PPM implantation. RESULTS: In total, 168 patients were included in the study. PPM was implanted in 65 patients (38.7%). In 23 patients, a PPM was implanted the same day with TAVI (Group A) and in 42 patients PPM implantation was postponed at least 1 day (Group B). Cephalic vein was the access used for the leads in the majority of cases. There was only one case of pneumothorax in Group B. There were no differences in the incidence of pocket hematomas between the study groups. CONCLUSIONS: Same-day PPM implantation after TAVI is safe and feasible. Strategies reducing pocket hematomas are essential in such patients of high hemorrhagic risk.

Oxidative stress and early atherosclerosis: novel antioxidant treatment.

Atherosclerotic lesions initiate in regions characterized by low shear stress and reduced activity of endothelial atheroprotective molecules such as nitric oxide, which is the key molecule managing vascular homeostasis. The generation of reactive oxygen species from the vascular endothelium is strongly related to various enzymes, such as xanthine oxidase, endothelial nitric oxide synthase and nicotinamide-adenine dinucleotide phosphate oxidase. Several pharmaceutical agents, including angiotensin converting enzyme inhibitors, angiotensin receptors blockers and statins, along with a variety of other agents, have demonstrated additional antioxidant properties beyond their principal role. Reports regarding the antioxidant role of vitamins present controversial results, especially those based on large scale studies. In addition, there is growing interest on the role of dietary flavonoids and their potential to improve endothelial function by modifying the oxidative stress status. However, the vascular-protective role of flavonoids and especially their antioxidant properties are still under investigation. Indeed, further research is required to establish the impact of the proposed new therapeutic strategies in atherosclerosis.

Effect of Angiotensin converting enzyme inhibitors on soluble tumor-necrosis-factor-related apoptosis-inducing ligand levels - association with neointimal hyperplasia in drug eluting stents.

OBJECTIVE: To test the hypothesis that angiotensin converting enzyme inhibitors (ACEi) affect soluble tumor-necrosis-factor-related apoptosis-inducing ligand (sTRAIL) and this interaction is associated with less in-drug-eluting-stent (DES) neointimal hyperplasia following percutaneous coronary intervention (PCI). METHODS: From our database of patients with elective PCI and baseline intravascular ultrasound (IVUS) evaluation of the implanted DES, we randomly selected 60 patients who were prescribed an ACEi and 60 matched controls, who did not receive an ACEi following PCI. All patients underwent coronary angiography and IVUS. sTRAIL was measured in samples from the stented coronary artery and a peripheral vein. RESULTS: sTRAIL concentration was higher in the ACEi group, both in coronary and peripheral samples: 104 [78-139] pg/ml versus 63 [45-100] pg/ml (P < 0.001) and 99 [73-135] pg/ml versus 69 [49-103] pg/ml (P = 0.002), respectively. There was an inverse association (standardized beta -0.760; P < 0.001) between sTRAIL and lumen area loss in both treatment groups. In the multivariable analysis, log(sTRAIL) was an independent negative predictor of lumen area loss (standardized beta -0.660, adjusted 95% confidence interval -0.722 to -0.466). CONCLUSIONS: Treatment with ACEi was associated with higher sTRAIL levels and lower lumen area loss in the IVUS evaluation of implanted DES. sTRAIL levels were negatively associated with in-stent neointima hyperplasia in these post-PCI patients.

Impact of Stress Echocardiography on Aortic Valve Stenosis Management.

Rest and stress echocardiography (SE) play a fundamental role in the evaluation of aortic valve stenosis (AS). According to the current guidelines for the echocardiographic evaluation of patients with aortic stenosis, four broad categories can be defined: high-gradient AS (mean gradient ≥ 40 mmHg, peak velocity ≥ 4 m/s, aortic valve area (AVA) ≤ 1 cm2 or indexed AVA ≤ 0.6 cm2/m2); low-flow, low-gradient AS with reduced ejection fraction (mean gradient < 40 mmHg, AVA ≤ 1 cm2, left ventricle ejection fraction (LVEF) < 50%, stroke volume index (Svi) ≤ 35 mL/m2); low-flow, low-gradient AS with preserved ejection fraction (mean gradient < 40 mmHg, AVA ≤ 1 cm2, LVEF ≥ 50%, SVi ≤ 35 mL/m2); and normal-flow, low-gradient AS with preserved ejection fraction (mean gradient < 40 mmHg, AVA ≤ 1 cm2, indexed AVA ≤ 0.6 cm2/m2, LVEF ≥ 50%, SVi > 35 mL/m2). Aortic valve replacement (AVR) is indicated with the onset of symptoms development or LVEF reduction. However, there is often mismatch between resting transthoracic echocardiography findings and patient's symptoms. In these discordant cases, SE and CT calcium scoring are among the indicated methods to guide the management decision making. Additionally, due to the increasing evidence that in asymptomatic severe aortic stenosis an early AVR instead of conservative treatment is associated with better outcomes, SE can help identify those that would benefit from an early AVR by revealing markers of poor prognosis. Low-flow, low-gradient AS represents a challenge both in diagnosis and in therapeutic management. Low-dose dobutamine SE is the recommended method to distinguish true-severe from pseudo-severe stenosis and assess the existence of flow (contractile) reserve to appropriately guide the need for intervention in these patients.

Long-Term Outcomes of Aortic Stenosis Patients with Different Flow/Gradient Patterns Undergoing Transcatheter Aortic Valve Implantation.

Background: Few data exist on the comparative long-term outcomes of severe aortic stenosis (AS) patients with different flow-gradient patterns undergoing transcatheter aortic valve implantation (TAVI). This study sought to evaluate the impact of the pre-TAVI flow-gradient pattern on long-term clinical outcomes after TAVI and assess changes in the left ventricular ejection fraction (LVEF) of different subtypes of AS patients following TAVI. Methods: Consecutive patients with severe AS undergoing TAVI in our institution were screened and prospectively enrolled. Patients were divided into four subgroups according to pre-TAVI flow/gradient pattern: (i) low flow-low gradient (LF-LG): stroke volume indexed (SVi) ≤ 35 mL/m2 and mean gradient (MG) < 40 mmHg); (ii) normal flow-low gradient (NF-LG): SVi > 35 mL/m2 and MG < 40 mmHg; (iii) low flow-high gradient (LF-HG): Svi 35 mL/m2 and MG ≥ 40 mmHg and (iv) normal flow-high gradient (NF-HG): SVi > 35 mL/m2 and MG ≥ 40 mmHg. Transthoracic echocardiography was repeated at 1-year follow-up. Clinical follow-up was obtained at 12 months, and yearly thereafter until 5-year follow-up was complete for all patients. Results: A total of 272 patients with complete echocardiographic and clinical follow-up were included in our analysis. Their mean age was 80 ± 7 years and the majority of patients (N = 138, 50.8%) were women. 62 patients (22.8% of the study population) were distributed in the LF-LG group, 98 patients (36%) were LF-HG patients, 95 patients (34.9%) were NF-HG, and 17 patients (6.3%) were NF-LG. There was a greater prevalence of comorbidities among LF-LG AS patients. One-year all-cause mortality differed significantly between the four subgroups of AS patients (log-rank p: 0.022) and was more prevalent among LF-LG patients (25.8%) compared to LF-HG (11.3%), NF-HG (6.3%) and NF-LG patients (18.8%). At 5-year follow-up, global mortality remained persistently higher among LF-LG patients (64.5%) compared to LF-HG (47.9%), NF-HG (42.9%), and NF-LG patients (58.8%) (log-rank p: 0.029). At multivariable Cox hazard regression analysis, baseline SVi (HR: 0.951, 95% C.I.; 0.918-0.984), the presence of at least moderate tricuspid regurgitation at baseline (HR: 3.091, 95% C.I: 1.645-5.809) and at least moderate paravalvular leak (PVL) post-TAVI (HR: 1.456, 95% C.I.: 1.106-1.792) were significant independent predictors of late global mortality. LF-LG patients and LF-HG patients exhibited a significant increase in LVEF at 1-year follow-up. A lower LVEF (p < 0.001) and a lower Svi (p < 0.001) at baseline were associated with LVEF improvement at 1-year. Conclusions: Patients with LF-LG AS have acceptable 1-year outcomes with significant improvement in LVEF at 1-year follow-up, but exhibit exceedingly high 5-year mortality following TAVI. The presence of low transvalvular flow and at least moderate tricuspid regurgitation at baseline and significant paravalvular leak post-TAVI were associated with poorer long-term outcomes in the entire cohort of AS patients. The presence of a low LVEF or a low SVi predicts LVEF improvement at 1-year.

Mortality Rates in Patients Undergoing Urgent Versus Elective Transcatheter Aortic Valve Replacement: A Meta-analysis.

Patients with severe aortic stenosis (AoS) often present with acute heart failure and compensation, frequently leading to cardiogenic shock. Transcatheter Aortic Valve Replacement (TAVR) has been recently performed as a bailout treatment in such patients. The aim of our meta-analysis is to compare urgent TAVR with elective procedures. We systematically screened three databases searching for studies comparing urgent vs elective TAVR. Primary endpoint is the 30-days mortality. Secondary endpoints included in-hospital mortality, device success, periprocedural vascular complications, 30-days stroke, 30-days acute kidney injury (AKI), permanent pacemaker implantation (PPM), moderate or severe paravalvular leakage, and 30-days bleeding. Seventeen studies were included, with a total of 84,495 patients. Urgent TAVR was associated with an increased risk for 30-days mortality [Risk Ratio (RR): 2.53, 95% Confidence Intervals (CI): 1.81-3.54)], in-hospital mortality (RR: 2.67, 95% CI: 1.94-3.68), periprocedural vascular complications (RR: 1.91, 95% CI: 1.28-2.85) and AKI (RR: 2.83, 95% CI: 1.93-4.14), compared with elective procedure. No differences were observed in the other secondary endpoints. Urgent TAVR was associated with higher in-hospital and 30-days mortality, possibly driven by the increased incidence of AKI and vascular complications in urgent TAVR. The results highlight the importance of early TAVR in stable AoS patients.

Cardiac arrest and cardiopulmonary resuscitation in "hostile" environments: Using automated compression devices to minimize the rescuers' danger.

Mechanical automated compression devices are being used in cardiopulmonary resuscitation instead of manual, "hands-on", rescuer-delivered chest compressions. The -theoretical- advantages include high-quality non-stop compressions, thus freeing the rescuer performing the compressions and additionally the ability of the rescuer to stand reasonably away from a potentially "hazardous" victim, or from hazardous and/or difficult resuscitation conditions. Such circumstances involve cardiopulmonary resuscitation (CPR) in the Cardiac Catheterization Laboratory, especially directly under the fluoroscopy panel, where radiation is well known to cause detrimental effects to the rescuer, and CPR during/after land or air transportation of cardiac arrest victims. Lastly, CPR in a coronavirus disease 2019 patient/ward, where the danger of contamination and further serious illness of the health provider is very existent. The scope of this review is to review and present literature and current guidelines regarding the use of mechanical compressions in these "hostile" and dangerous settings, while comparing them to manual compressions.

Overcoming the Obstacle of Suicide Left Ventricle After Transcatheter Aortic Valve Replacement Phenomenon.

Suicide left ventricle after transcatheter aortic valve replacement is a well described phenomenon associated with increased morbidity and mortality. Prompt actions should be implemented to prevent this situation, and the alarm signs should be recognized. We present a case report of successful recognition, prevention and treatment of this complication. (Level of Difficulty: Intermediate.).

Study Level Meta-Analysis of Transcatheter Aortic Valve Implantation With the ACURATE neo Self-Expanding Transcatheter Heart Valve.

The ACURATE neo transcatheter aortic valve is a self-expanding device. Several studies have investigated safety and efficacy, but meta-analysis and pooled data are lacking. We aimed to provide a comprehensive systematic review and meta-analysis on the clinical outcomes of transcatheter aortic valve implantation with the ACURATE neo valve. A systematic literature search for eligible records was conducted. The primary endpoint was device success as designated by Valve Academic Research Consortium-2 criteria. The secondary endpoints (time frame: 30 days) were all-cause mortality, stroke, myocardial infarction, need for new permanent pacemaker, major vascular complications, major bleeding, acute kidney injury stage II or III, and paravalvular regurgitation grade moderate or severe (II or III). Our search yielded a total of 355 records, 20 of those (n = 5858 ACURATE neo receivers) were included in our meta-analysis. Device success was achieved in 94.5% (95% confidence interval [CI], 91.4-96.5%) of the patients. The 30-day all-cause mortality incidence proportion was 1.8% (95% CI, 1.3-2.4%). New pacemaker implantation was required in 7.7% (95% CI, 6.4-9.2%) of the patients, stroke occurred in 1.9% (95% CI, 1.6-2.3%), myocardial infarction in 0.5% (95% CI, 0.3-0.7%), major bleeding in 5.0% (95% CI, 3.9-6.5%), major vascular complication in 5.6% (95% CI, 4.0-7.8%), acute kidney injury stage ≥2 in 2.5% (95% CI, 1.8-3.4%), and paravalvular leak grade ≥moderate was observed in 4.3% (95% CI, 3.0-6.2%). Balloon predilatation and postdilatation incidence was 93.9% (95% CI, 87.0-97.3%) and 43.2% (95% CI, 37.9-48.6%), respectively. ACURATE neo appears to be safe and effective in our analysis with high device success incidence, low mortality, and low new pacemaker implantations.

The Role of ECG Strain Pattern in Prognosis after TAVI: A Sub-Analysis of the DIRECT Trial.

BACKGROUND: The presence of an electrocardiographic (ECG) strain pattern-among other ECG features-has been shown to be predictive of adverse cardiovascular outcomes in asymptomatic patients with aortic stenosis. However, data evaluating its impact on symptomatic patients undergoing TAVI are scarce. Therefore, we tried to investigate the prognostic impact of baseline ECG strain pattern on clinical outcomes after TAVI. METHODS: A sub-group of patients of the randomized DIRECT (Pre-dilatation in Transcatheter Aortic Valve Implantation Trial) trial with severe aortic stenosis who underwent TAVI with a self-expanding valve in one single center were consecutively enrolled. Patients were categorized into two groups according to the presence of ECG strain. Left ventricular strain was defined as the presence of ≥1 mm convex ST-segment depression with asymmetrical T-wave inversion in leads V5 to V6 on the baseline 12-lead ECG. Patients were excluded if they had paced rhythm or left bundle branch block at baseline. Multivariate Cox proportional hazard regression models were generated to assess the impact on outcomes. The primary clinical endpoint was all-cause mortality at 1 year after TAVI. RESULTS: Of the 119 patients screened, 5 patients were excluded due to left bundle branch block. Among the 114 included patients (mean age: 80.8 ± 7), 37 patients (32.5%) had strain pattern on pre-TAVI ECG, while 77 patients (67.5%) did not exhibit an ECG strain pattern. No differences in baseline characteristics were found between the two groups. At 1 year, seven patients reached the primary clinical endpoint, with patients in the strain group demonstrating significantly higher mortality in Kaplan-Meier plots compared to patients without left ventricular strain (five vs. two, log-rank p = 0.022). There was no difference between the strain and no strain group regarding the performance of pre-dilatation (21 vs. 33, chi-square p = 0.164). In the multivariate analysis, left ventricular strain was found to be an independent predictor of all-cause mortality after TAVI [Exp(B): 12.2, 95% Confidence Intervals (CI): 1.4-101.9]. CONCLUSION: Left ventricular ECG strain is an independent predictor of all-cause mortality after TAVI. Thus, baseline ECG characteristics may aid in risk-stratifying patients scheduled for TAVI.