Pacemaker dependency and conduction system recovery following transcatheter aortic valve implantation.

BACKGROUND: Transcatheter aortic valve implantation (TAVI)-related conduction system disorders are dynamic and may resolve over time. The purpose of this study was to investigate predictive factors of PM dependency among patients receiving permanent PM implantation after TAVI. METHODS: We included 37 consecutive patients who underwent PPM implantation within six days after TAVI and who completed a 12-month follow-up. Patients were divided into two groups according to PPM dependency at follow-up: PPM-dependent group and non-PPM-dependent group. Device follow-ups were performed at one, six and 12 months. RESULTS: There were no significant differences in either baseline clinical characteristics or procedural data and results. Analysis of baseline ECGs showed a statistical difference in PR interval (200.1±17.2 ms in the PPM-dependent group vs. 175±23.3 ms in the non PPM-dependent group [P=0,003]) and in the presence of RBBB (four patients in the PPM-dependent group vs. no patients in the non PPM-dependent group [P=0.02]) as well as QRS duration (117.3±27.4 ms in the PPM-dependent group and 99±18.3 msec in the non PPM-dependent group [P=0.04]). CONCLUSIONS: The rate of PPM dependency was significantly reduced at 12-month follow-up: from 62,2% at the time of implantation to 35,1%. PR interval and RBBB were the most important predictive factors for PPM dependency. Persistent AVB and alternating BBB were prevalent in the PPM-dependent group. In the absence of persistent AVB or alternating BBB, we suggest that patients without long PR interval and RBBB at baseline ECG be carefully evaluated before permanent PM implantation, as conduction system recovery is possible.

Effect of acute CORticosteroids on conduction defects after Transcatheter Aortic Valve Implantation: the CORTAVI study.

AIMS: Conduction abnormalities, requiring a permanent pacemaker (PPM), are the most common electrical complications after transcatheter aortic valve implantation (TAVI). The exact mechanism for conduction system defects is not yet clear. The local inflammatory process and edema are thought to play a role in the development of electrical disorders. Corticosteroids are effective anti-inflammatory and antiedematous agents. We aim to investigate the potential protective effect of corticosteroids on conduction defects after TAVI. METHODS: This is a retrospective study of a single center. We analyzed 96 patients treated with TAVI. Thirty-two patients received oral prednisone 50 mg for 5 days after the procedure. This population was compared with the control group. All patients were followed up after 2 years. RESULTS: Of the 96 patients included, 32 (34%) were exposed to glucocorticoids after TAVI. No differences in age, preexisting right bundle branch block or left bundle branch block, or valve type were seen among patients exposed to glucocorticoids versus those who were unexposed. We observed no significant differences between the two groups in the overall frequency of new PPM implantations during hospitalization (12% vs. 17%, P  = 0.76). The incidence of atrioventricular block (AVB) (STx 9% vs. non-STx 9%, P  = 0.89), right bundle branch block (STx 6% vs. non-STx 11%, P  = 0.71), and left bundle branch block (STx 34% vs. non-STx 31%, P  = 0.9) was not significantly different between the STx and non-STx groups. At 2 years after TAVI, none of the patients had implanted PPM or had severe arrhythmias documented by 24-h Holter ECG or cardiac examination. CONCLUSION: Oral prednisone treatment does not appear to significantly reduce the incidence of AVB requiring acute PPM implantation after TAVI.

Advances in Imaging for Tricuspid Transcatheter Edge-to-Edge Repair: Lessons Learned and Future Perspectives.

Severe tricuspid valve (TV) regurgitation (TR) has been associated with adverse long-term outcomes in several natural history studies, but isolated TV surgery presents high mortality and morbidity rates. Transcatheter tricuspid valve interventions (TTVI) therefore represent a promising field and may currently be considered in patients with severe secondary TR that have a prohibitive surgical risk. Tricuspid transcatheter edge-to-edge repair (T-TEER) represents one of the most frequently used TTVI options. Accurate imaging of the tricuspid valve (TV) apparatus is crucial for T-TEER preprocedural planning, in order to select the right candidates, and is also fundamental for intraprocedural guidance and post-procedural follow-up. Although transesophageal echocardiography represents the main imaging modality, we describe the utility and additional value of other imaging modalities such as cardiac CT and MRI, intracardiac echocardiography, fluoroscopy, and fusion imaging to assist T-TEER. Developments in the field of 3D printing, computational models, and artificial intelligence hold great promise in improving the assessment and management of patients with valvular heart disease.

Transcatheter aortic valve implantation results are not superimposable to surgery in patients with aortic stenosis at low surgical risk.

BACKGROUND: The aim of this meta-analysis was to compare the impact of transcatheter aortic valve implantation (TAVI) vs. surgical aortic valve replacement (SAVR) in patients with severe aortic valve stenosis (AS) at low surgical risk. METHODS: All randomized controlled trials (RCTs) and observational studies (Obs) published from January 2014 until March 31st, 2020 were retrieved through the PubMed computerized database and at the site https://www. CLINICALTRIALS: com. The relative risk (RR) with the 95% confidence interval (CI) was used to evaluate the effect of the intervention under comparison. The primary endpoints were all-cause 30-day mortality and 1-year mortality. The 30-day safety endpoints were: stroke, acute kidney injury stage 2 or 3, major bleeding, moderate/severe paravalvular leak, need for new permanent pacemaker (PM) implantation. RESULTS: After detailed review 9 studies, related to 4 RCTs and 5 Obs, were selected. The overall analysis of RCTs plus Obs showed a significantly lower 30-day mortality for TAVI (RR = 0.55; 95% CI 0.45-0.68, p < 0.00001; I2 = 0%). However, an increased risk of new PM implantation (RR = 2.87; 95% CI 2.01-3.67, p < 0.00001, I2 = 0%) and of paravalvular leak (RR = 7.28; 95% CI 3.83-13.81, p < 0.00001, I2 = 0%) was observed in TAVI compared to SAVR. On the contrary, a lower incidence of major bleeding (RR = 0.38; 95% CI 0.27-0.54, p < 0.00001, I2 = 0%) and of acute kidney injury was observed (RR = 0.33; 95% CI 0.19-0.56, p < 0.0001, I2 = 0%) in TAVI. CONCLUSIONS: TAVI and SVAR in the treatment of AS in the patients at low surgical risk are not superimposable. In particular, if 30-day and 1-year mortality, major bleeding and acute kidney injury were significantly lower for TAVI, the need of new PM implantation and paravalvular leak were significantly lower in SAVR. Consequently, we suggest the need of more trials to evaluate the effectiveness of TAVI as routine therapeutic procedure in the treatment of patients with low surgical risk AS.

Current Options and Future Perspectives in the Treatment of Dyslipidemia.

Low-density lipoprotein cholesterol (LDL-C) plays a crucial role in the development of atherosclerosis. Statin therapy is the standard treatment for lowering LDL-C in primary and secondary prevention. However, some patients do not reach optimal LDL-C target levels or do not tolerate statins, especially when taking high doses long-term. Combining statins with different therapeutic approaches and testing other new drugs is the future key to reducing the burden of cardiovascular disease (CVD). Recently, several new cholesterol-lowering drugs have been developed and approved; others are promising results, enriching the pharmacological armamentarium beyond statins. Triglycerides also play an important role in the development of CVD; new therapeutic approaches are also very promising for their treatment. Familial hypercholesterolemia (FH) can lead to CVD early in life. These patients respond poorly to conventional therapies. Recently, however, new and promising pharmacological strategies have become available. This narrative review provides an overview of the new drugs for the treatment of dyslipidemia, their current status, ongoing clinical or preclinical trials, and their prospects. We also discuss the new alternative therapies for the treatment of dyslipidemia and their relevance to practice.

Combined MitraClip and Left Atrial Appendage Occlusion: Is It Still a Utopia?

Atrial fibrillation (AF) is the most common cardiac arrhythmia, affecting 32 million individuals worldwide, particularly the elderly. It is the main cause of ischemic strokes. Oral anticoagulation (OAC) is the gold standard strategy for stroke prevention. Still, there is a not negligible share of patients who have contraindications to this therapy, more frequently due to an increased risk of bleeding. AF is often associated with moderate-severe mitral regurgitation (MR), the second most frequent valvular disease in elderly patients. Data from the literature reported that more than half of patients with severe mitral regurgitation are not suitable candidates for cardiac surgery. Given the progressive aging of the population and the simultaneous increase in the number of patients with comorbidities, the advent of new therapeutic strategies, such as the combined approach of Left Atrial Appendage Occlusion (LAAO) and MitraClip procedure, is acquiring great interest. At present, the category of patients who may benefit from combined percutaneous therapies and the long-term risks and benefits might not have been identified. Despite the efforts of researchers, the correct selection of patients is a very important clinical need that has not yet been met to avoid committing human and financial resources to interventions that may be unnecessary. It is conceivable that the most modern and recent innovations in cardiovascular imaging, particularly three-dimensional echocardiography and new methods of volume imaging, could improve our ability to select patients appropriately. Since data in the literature are scarce, future studies will be needed to evaluate the efficacy and safety of combined MitraClip and LAA occlusion.

Who Has Seen Patients With ST-Segment-Elevation Myocardial Infarction? First Results From Italian Real-World Coronavirus Disease 2019.

Background After the coronavirus disease 2019 outbreak, social isolation measures were introduced to contain infection. Although there is currently a slowing down of the infection, a reduction of hospitalizations, especially for myocardial infarction, was observed. The aim of our study is to evaluate the impact of the infectious disease on ST-segment-elevation myocardial infarction (STEMI) care during the coronavirus disease 2019 pandemic, through the analysis of recent cases of patients who underwent percutaneous coronary intervention. Methods and Results Consecutive patients affected by STEMI from March 1 to 31, 2020, during social restrictions of Italian government, were collected and compared with patients with STEMI treated during March 2019. During March 2020, we observed a 63% reduction of patients with STEMI who were admitted to our catheterization laboratory, when compared with the same period of 2019 (13 versus 35 patients). Changes in all time components of STEMI care were notably observed, particularly for longer median time in symptom-to-first medical contact, spoke-to-hub, and the cumulative symptom-to-wire delay. Procedural data and in-hospital outcomes were similar between the 2 groups, whereas the length of hospitalization was longer in patients of 2020. In this group, we also observed higher levels of cardiac biomarkers and a worse left ventricular ejection fraction at baseline and discharge. Conclusions The coronavirus disease 2019 outbreak induced a reduction of hospital access for STEMI with an increase in treatment delay, longer hospitalization, higher levels of cardiac biomarkers, and worse left ventricular function.

Serum free light chains in patients with ST elevation myocardial infarction (STEMI): A possible correlation with left ventricle dysfunction.

BACKGROUND: Light chains are proteins produced by plasma cells, also called light chains kappa and lambda, are tied together with other proteins (heavy chains) to form the intact immunoglobulins or antibodies. Recent studies have shown a possible role of combined free light chains (cFLC) as an inflammatory marker in patients with chronic heart failure (HF). HF is a significant contributor to overall mortality in the community, but often patients with chronic HF also have chronic renal failure, which could alter the concentration of cFLC. METHODS: We evaluated the FLC in patients with STEMI (n = 113), who were treated with primary angioplasty in the Cardiology Department of the University Hospital "Tor Vergata". For each patient during hospitalization we have determined blood concentration of cFLC, in addition to routine blood tests and we also performed an echocardiogram to evaluate cardiac function. RESULTS: We performed cFLC serum concentration in 113 patients with STEMI and observed that the cFLC concentration correlates with Left Ventricle Ejection Fraction (LVEF). We identified that the majority of patients (97%) who had one of the two positive light chains also had a reduced systolic function (LVEF <50%). CONCLUSIONS: For the first time in this paper we highlight the increase of serum free light chains concentrations in acute ischemic heart failure in patients with STEMI and without kidney failure. The cFLC could be proposed as a new biomarker for left ventricle dysfunction, further studies are required to confirm these results.

Carotid Doppler sonography: additional tool to assess hemodynamic improvement after transcatheter aortic valve implantation.

PURPOSE: The aim of our study was to assess the arterial cerebral blood flow variations in patients with aortic valve stenosis, immediately after the transcatheter aortic valve implantation (TAVI). METHODS: The study population includes 62 consecutive patients who underwent TAVI for aortic valve stenosis (95%) and sugical bioprosthesis degeneration (5%). Carotid Doppler examination was performed recording blood flow, systolic peak velocity, time average mean velocity and mean acceleration time at baseline, after balloon aortic valvuloplasty, and within 10 min after the device release. RESULTS: A significant improvement of blood flow was recorded at the end of the procedure (from 315.05 ±â€Š141.72 to 538.67 ±â€Š277.46 ml/min; P < 0.00001). The systolic peak velocity and the time average mean velocity increased from 52.27 ±â€Š14.29 to 78.89 ±â€Š20.48 cm/s (P < 0.00001) and from 12.24 ±â€Š4.74 to 21.21 ±â€Š9 cm/s (P < 0.00001), respectively. Consensually, the mean acceleration time decreased from 0.22 ±â€Š0.02 to 0.03 ±â€Š0.02 s (P < 0.00001) after the procedure. CONCLUSION: Monitoring of Doppler measurements may be a useful and noninvasive method to assess acutely the improvement of hemodynamic flow after TAVI, specifically for the cerebral district.

From patients' needs to treatment outcomes in psoriasis: Results from the 'pSORRIDI' experience.

OBJECTIVE: To evaluate results of the 'pSORRIDI' experience (which is a prevention campaign to evaluate the prevalence of comorbidities, multidisciplinary needs and appropriateness of the therapeutic approach for comorbidities) in patients already being treated for psoriasis. METHODS: Telephone interviews were conducted in patients with psoriasis, who then underwent comprehensive evaluation and investigation of comorbidities. If necessary, patients were referred to specialist cardiology, endocrinology and/or rheumatology services. RESULTS: Overall, 72.0% (54/75) of patients required a multidisciplinary consultation. Among patients referred to cardiology, therapeutic adjustment was needed in 33.3% (five of 15) patients and a redefined diagnosis in 26.7% (four of 15) cases. Among patients undergoing endocrinology evaluations, therapeutic adjustment and a redefined diagnosis were needed in 61.1% (11/18) and 33.3% (six of 18) patients, respectively; for rheumatology evaluations, therapeutic adjustment and a redefined diagnosis were needed in 76.2% (16/21) and 19.0% (four of 21) of patients, respectively. CONCLUSIONS: Among patients with psoriasis, there may be a need for an improvement in the diagnosis of underlying comorbid conditions, and in disease management of both psoriasis and any comorbid conditions.

Trans-catheter mitral valve implantation for mitral regurgitation: clinical case description and literature review.

Trans-catheter mitral valve implantation (TMVI) is actually the most attractive technique for treating patients with severe mitral regurgitation, who are denied surgical therapy. Recently, trans-catheter implantation of aortic biological prosthesis in mitral position has been done in compassionate cases, and very few experiences of TMVI in native non-calcified valves have been recently reported in very-high-risk patients, mainly with functional mitral regurgitation.Here, we report our case of TMVI using the second-generation CardiAQ prostheisis (CardiAQ Valve Technologies, Irvine, California, USA), reviewing the current state of the art.

Cardiovascular medicine heart failure (CVM-HF) index as prognostic model for candidates to MitraClip therapy.

Transcatheter MitraClip repair is a new tool for the management of severe mitral regurgitation in patients at very high risk for conventional surgery. Aim of our study was reporting one-year clinical outcomes in candidates to MitraClip procedures, divided into three groups according to the cardiovascular medicine heart failure (CVM-HF) index. The study population consists of 46 consecutive patients, divided, in accordance with CVM-HF index, as follows: one patient in the low-risk category (group A); 27 patients in the medium-risk (group B) and 18 patients in high-risk category (group C). The primary study endpoint was a combined of all-cause mortality and re-hospitalization rate. Secondary endpoints were all-cause mortality and cardiac mortality. Patients of group B and group C were compared. Regarding the primary endpoint, patients in group C had significantly poorer outcomes than patients in group B, with a 12-month survival freedom from events of 44.4  and 74.1 %, respectively (log-rank test, p = 0.039); survival freedom from cardiac mortality was 100 and 83.3 % in group B and C, respectively (log-rank test, p = 0.027). One-year survival free from re-hospitalization was 74.1 % in group B and 39.9 % in group C (log-rank test; p = 0.036). Survival free from all-cause of mortality was 92.6 and 77.8 %, respectively (log-rank test; p = 0.129). In our initial experience the CVM-HF index showed to be valuable for understanding if the patient with advanced heart failure and functional mitral regurgitation can really benefit by MitraClip therapy.

Percutaneous transfemoral-transseptal implantation of a second-generation CardiAQ mitral valve bioprosthesis: first procedure description and 30-day follow-up.

AIMS: Transcatheter mitral valve implantation for mitral valve regurgitation is in the very early phase of development because of challenging anatomy and device dimensions. We describe the procedure of a transfemoral-transseptal implantation of the second-generation CardiAQ mitral valve bioprosthesis and 30-day follow-up. METHODS AND RESULTS: The procedure was performed percutaneously, without any left extracorporeal circulatory support. The patient had severe mitral regurgitation with severely depressed ventricular function and other comorbidities. The patient was deemed extreme high risk for conventional cardiac surgery by a multidisciplinary team. The main procedural steps were the creation of an arteriovenous loop with an exchange nitinol wire, and the use of a customised "steerable snare system" to facilitate the catheter delivery system into the mitral annulus. Transoesophageal echocardiography and fluoroscopy were utilised for device positioning and deployment. The mitral valve prosthesis was implanted with mild mitral regurgitation. The postoperative course was uneventful and at 30-day follow-up the patient is in NYHA Class I, with good function of the mitral valve bioprosthesis. CONCLUSIONS: This procedure shows that percutaneous transfemoral transcatheter mitral valve implantation is feasible, safe and successful. Further experience is needed to render this procedure clinically available.

Clinical results with the 31 mm CoreValveª in large aortic annuli: the importance of implantation technique.

AIMS: The CoreValve Revalving System (CRS) (Medtronic Inc., Minneapolis, MN, USA) is currently available in four sizes: 23 mm, 26 mm, 29 mm and 31 mm. Aim of our study was to assess the acute clinical results after implantation of a 31 mm CRS. METHODS AND RESULTS: We assessed device safety, procedural success and 30-day outcomes of 76 consecutive patients who underwent transcatheter aortic valve implantation (TAVI) from January 2012 to September 2013, for severe aortic valve disease. The device sizes used were 26 mm in 21 (28%), 29 mm in 20 (26%) and 31 mm in 35 (46%) patients. Patients who received the 31 mm CRS were significantly younger, predominantly male, with higher STS scores and lower left ventricular ejection fraction. Device success was obtained in 70 cases (92%) in the overall population, without significant differences among groups. Procedural, fluoroscopy and revalving time and procedural outcomes did not differ. A significant reduction in transaortic gradient was obtained in all groups. We observed a low incidence of paraprosthetic leak in the 31 mm group. Permanent pacemaker implantation, bleeding, vascular and renal complications were similar among groups. Time of hospitalisation in CRS 31 mm patients did not differ from the other groups and 30-day outcomes were comparable. CONCLUSIONS: The 31 mm CRS can be safely implanted in patients with complex aortic valve disease, large annuli and dilated left ventricles.

Transcatheter aortic valve implantation through distal axillary artery: novel option for vascular access.

AIMS: We describe an alternative access approach for patients undergoing transcatheter aortic valve implantation (TAVI) using surgical cut down of the distal axillary artery, in cases wherein transfemoral access is not feasible. METHODS: From January 2012 to July 2013, 61 patients (59% men; mean age 81 ±â€Š8 years) underwent TAVI at our institution. The mean logistic EuroSCORE and EuroSCORE II were 36 ±â€Š24 and 14 ±â€Š10, respectively. We assessed device success, 30-day safety and clinical efficacy using VARC II criteria. RESULTS: TAVI was performed with the CoreValve Revalving System (CRS) (Medtronic Inc., Minneapolis, Minnesota, USA) in all cases, using transfemoral approach in 57 patients and distal trans-axillary route in four patients. A device was successfully implanted in 94%, without any major intraprocedural complications. One case of acute kidney disease, four cases of minor vascular complication and two cases of life-threatening bleeding occurred after the procedure for pericardial bleeding requiring pericardiocentesis. Permanent pacemaker was implanted in 26% of patients. There was no instance of in-hospital mortality, while two deaths (3%) occurred in the first 30 days. The total procedure time (skin-to-skin) was longer in the trans-axillary group secondary to surgical management of access site (P = 0.027), whereas revalving and fluoroscopy time were similar (P = 0.95 and P = 0.83, respectively). CONCLUSION: The location and anatomical relations of the distal axillary artery make it a safer, reproducible and operator friendly access option for TAVI.

Hemodynamic patterns of residual interatrial communication after transcatheter MitraClip repair.

AIMS: We sought to assess the hemodynamic sequel and the therapy adopted in patients treated with MitraClip system, who experienced a persistent interatrial communication (IAC) after the procedure. METHODS: From January 2012 to March 2013, 28 consecutive patients (mean age 74 +/- 8 years) underwent transcatheter MitraClip repair, as part of an ongoing prospective study to assess the IAC. RESULTS: Acute procedural success was 100% and a 30-days survival of 97% was reported. Immediately after the procedure, a residual IAC was present in all patients with an average diameter of 0.51 +/- 0.39 cm. At 30 days, IAC was detected in 81% of patients with a diameter of 0.45 +/- 0.31 cm (P = 0.53). To date, three patients developed different hemodynamic impairment secondary to the residual IAC, requiring percutaneous closure of the defect. CONCLUSION: Anatomic and hemodynamic criteria for early recognition of harmful residual IAC have to be identified, in order to select those patients who are benefited the most from atrial septal defect closure.

Percutaneous closure of patent foramen ovale with Atriasept II device in nickel allergic patients.

There are concerns about percutaneous closure of patent foramen ovale (PFO) using nitinol-alloys devices in patients with nickel hypersensitivity. We describe our experience with Atriasept II (Cardia Eagan, Minnesota, USA) used in four patients with known nickel allergy. No intraprocedural or in-hospital adverse events occurred. The follow-up was negative for allergic manifestations, without complications, as assessed by echocardiography. Because of the risk of adverse outcomes in nickel-allergic patients, devices with higher biocompatibility, low-profile, and low nickel content should be preferred in cases of known hypersensitivity. Atriasept II, containing less metallic material, appears to be a safe option in allergic patients undergoing PFO closure.