VersaCross Transseptal System for Mitral Transcatheter Edge-To-Edge Repair With the PASCAL Repair Platform.

Background: VersaCross is a novel radiofrequency transseptal solution that may improve the efficiency and workflow of transseptal puncture (TSP). The aim of this study was to compare the VersaCross transseptal system with mechanical needle systems during mitral transcatheter edge-to-edge repair (M-TEER) with the PASCAL device. Methods: This is a single-center retrospective study of consecutive patients who underwent M-TEER with the PASCAL. Transseptal puncture was undertaken with either a mechanical needle or the VersaCross wire. The primary endpoints were success of TSP and successful delivery of the Edwards sheath on the chosen delivery wire. Secondary endpoints included number of wires used, tamponade rate, interval from femoral venous access to TSP and first PASCAL device deployment, procedural death, and stroke. Results: Thirty-three consecutive patients (10 with mechanical needle, 23 with VersaCross) who underwent M-TEER with the Edwards PASCAL device were identified. All patients had successful TSP. In the mechanical needle group, the Edwards sheath was successfully delivered on the Superstiff Amplatz wire in all cases. In the VersaCross arm, the radiofrequency wire was used successfully for delivery of the sheath in all cases. There were no cases of pericardial effusion/tamponade in either arm. Interval from femoral venous access to TSP and to deployment of the first PASCAL device was shorter with the VersaCross system. Significantly fewer wires were used with VersaCross. There were no procedural deaths or strokes in either group. Conclusions: VersaCross appears a safe and effective method of TSP and for delivery of the 22Fr sheath for M-TEER with PASCAL.

Routine postaccess-closure angiography to detect vascular complications following transfemoral TAVR.

BACKGROUND: Vascular complications following transfemoral TAVR are associated with increased morbidity and mortality. Measures that may mitigate this risk are important. AIM: To evaluate the utility of routine, access-vessel angiography post sheath-removal in the detection and management of complications in patients undergoing transcatheter aortic valve replacement (TAVR). METHODS: This was a retrospective study of 512 consecutive patients who underwent transfemoral TAVR with routine post access-closure angiography from the radial artery. Rates of mild angiographically evident bleeding, bleeding requiring surgery/interventional-radiology, ischemia, 90-day access-site-related events, and major and minor vascular complications using Valve Academic Research Consortium 3 definitions were recorded. RESULTS: Of 512 patients, digital subtraction angiography (DSA) was undertaken via the radial artery in 467 patients (91%). In the remaining patients (9%) DSA was either not attempted, due to concerns regarding kidney disease and contrast volume, or failed due to anatomical factors (aortic tortuosity/calcification). Significant chronic kidney disease was present at baseline in 72.4% of this cohort (stages III-IV or dialysis). Ninety-four percent of cases underwent TAVR using a balloon-expandable platform. Mild iliofemoral extravasation was observed in 7.7% of the DSA cases. These cases were managed by manual compression with none requiring any vascular intervention subsequently. Valve Academic Research Consortium 3 major and minor access-site-related complications were observed in 0.4% and 12.2%, respectively. Access-site-related bleeding and ischemic events requiring interventional-radiology or vascular-surgery were observed in 0.9% and 1.7% of the DSA cases, respectively. No new renal replacement therapy was needed in any of the DSA cases. Discharge to 90-day access-related complications was 0.8%. CONCLUSIONS: Routine post access-closure angiography is feasible via the radial artery in patients undergoing transfemoral TAVR and appears safe. It facilitates early identification of complications and mitigates risk by enabling prompt action to be taken. Larger studies are needed to confirm these findings.

Intraprocedural versus next day transthoracic echocardiography following minimalist transfemoral TAVI.

BACKGROUND: Routine pre-discharge echocardiography (ECHO) is recommended post transcatheter aortic valve implantation (TAVI) as a baseline for future comparison. However, there is no clear guidance on the optimal timing of this study. AIM: The purpose of this retrospective study was to investigate the safety and work-force efficiency of intraprocedural same-day ECHO versus next-day ECHO, following transfemoral TAVI. METHODS AND RESULTS: In this retrospective study 100 consecutive patients who underwent intraprocedural ECHO only were compared with 100 consecutive patients undergoing both intraprocedural and routine next-day ECHO following elective transfemoral TAVI. All patients received the Sapien 3/Ultra transcatheter heart valve and were treated with a minimalist procedure with conscious sedation. The composite of in-hospital mortality, urgent ECHO and new tamponade after leaving the cath lab and before discharge was not different between the two groups (4 vs. 4%, P = 1). There was no paravalvular leak more than mild in any of the cases. Length of stay was similar (1 day). CONCLUSIONS: Intraprocedural post-TAVI ECHO appears as safe as next day pre-discharge ECHO and obviates the need for a routine next day study, thereby reducing burden on echocardiography services and allows better utilisation of resources.

A very rare vascular complication of the Edwards expandable eSheath during transcatheter aortic valve replacement.

Transcatheter aortic valve replacement (TAVR) has revolutionized the management of severe symptomatic aortic valve stenosis. TAVR is now indicated as an alternative to surgical replacement in a wide risk profile ranging from high to low surgical risk. Although vascular complications have decreased in frequency over time, with the introduction of lower profile delivery systems and sheaths, they remain one of the most frequently encountered and serious complications of TAVR. Patient-specific predisposing factors have been well characterized. However, much less is known about device-specific complications. Awareness of the possible device-related complications may lead to earlier identification, prompt management, and better outcomes. We report a previously unreported complication of the Edwards expandable eSheath that lead to avulsion of the external iliac artery following successful TAVR with a 29-mm Edwards Sapien 3 transcatheter heart valve. Bleeding was promptly controlled with an occlusion balloon and emergency surgical repair was required with a favorable outcome.

A Modified Buddy-Wire Technique for Crossing of the Interatrial Septum With the Sapien 3 Valve During Transseptal Mitral Valve-in-Valve/Ring Procedures.

Background: Crossing of the interatrial septum (IAS) with the Edwards Sapien-3 transcatheter heart valve (THV) may fail, despite preparatory balloon septostomy. A planned buddy guidewire placed in the left ventricle may help facilitate crossing of the IAS and mitral bioprosthesis with the THV. Methods: A retrospective study of 12 consecutive patients undergoing transseptal, mitral valve-in-valve or valve-in-ring procedures using the Edwards Sapien-3 THV since 2018 with a planned buddy-wire technique. The primary endpoint was the composite of successful delivery of the buddy wire and deployment of the first intended Sapien 3 within the mitral valve without removal from the body, additional interatrial septal puncture, or placement of a further buddy wire. Secondary objectives included safety endpoints, as follows: access-site bleeding, tamponade, stroke, intraprocedural death, sustained ventricular arrhythmia, and 30-day vascular complications. Results: From January 2018 to March 2022, a total of 12 consecutive patients who underwent transseptal mitral valve-in-valve (9) or valve-in-ring (3) procedures were identified. Three patients (25%) required repeat septostomy on the buddy wire after initial THV crossing failure. Crossing of the IAS and successful deployment in the mitral valve with the THV was achieved in all cases, without removal from the body or need for an additional wire or septal puncture. No access-site bleeding, stroke, tamponade, ventricular arrhythmia, intraprocedural death, or 30-day vascular complication occurred. Conclusions: The planned buddy-wire technique was successful in all cases and facilitated successful crossing of the IAS and deployment of the THV in the mitral position without removal from the body, additional wires, or septal punctures, with no adverse events.

Contexte: Malgré une septostomie par ballonnet, le passage à travers le septum interatrial (SIA) d'une valve cardiaque implantée par cathéter (VCC) Sapien-3 d'Edwards peut se solder par un échec. Un fil-guide planifié, placé dans le ventricule gauche, pourrait aider à faciliter le passage de la VCC à travers le SIA et la bioprothèse mitrale. Méthodologie: Une étude rétrospective a été réalisée auprès de 12 patients consécutifs ayant subi une implantation mitrale transseptale dans le cas d'une bioprothèse mitrale (valve-in-valve) ou d'une annuloplastie chirurgicale (valve-in-ring) d'une VCC Sapien-3 d'Edwards avec la technique du fil-guide planifié, depuis 2018. Le critère d'évaluation principale composé comprenait le placement avec succès du fil-guide et le déploiement de la première valve Sapien-3 prévue dans la valve mitrale, sans devoir la sortir du corps, sans effectuer de ponction supplémentaire du septum interatrial et sans devoir placer de fil-guide supplémentaire. Les objectifs secondaires incluaient les critères d'innocuité suivants : saignement lié à l'accès vasculaire, tamponnade, accident vasculaire cérébral (AVC), décès en cours d'intervention, arythmie ventriculaire soutenue et complication vasculaire dans les 30 jours après l'intervention. Résultats: Entre janvier 2018 et mars 2022, un total de 12 patients consécutifs ayant subi une implantation mitrale transseptale pour une bioprothèse mitrale (neuf) ou pour une annuloplastie chirurgicale (trois) ont été recensés. Pour trois de ces patients (25 %), une deuxième septostomie, sur le fil-guide, a été nécessaire avec un échec initial du passage de la VCC. Le passage du SIA et le déploiement dans la valve mitrale avec la VCC ont été réussis dans tous les cas, sans devoir sortir la valve du corps, avoir recours à un fil supplémentaire ou effectuer une ponction du septum. Aucun cas de saignement lié à l'accès vasculaire, d'AVC, de tamponnade, d'arythmie ventriculaire, de décès en cours d'intervention ou de complication vasculaire dans les 30 jours après l'intervention n'est survenu. Conclusions: La technique du fil-guide a été couronnée de succès dans la totalité des cas, et a facilité le passage du SIA et le déploiement de la VCC en position mitral sans avoir besoin de sortir la valve du corps, d'avoir recours à des fils supplémentaires ou d'effectuer une ponction du septum; aucun effet indésirable n'est survenu.

A time-efficient protocol for transthoracic echocardiography during transfemoral transcatheter aortic valve implantation: early identification and effective management of intraprocedural complications.

Transfemoral transcatheter aortic valve implantation (TAVI) under conscious sedation is the most widely used method of implantation. Echocardiography is used to detect complications and to assess the implantation result. The aim of this paper is to provide a time-efficient protocol when transthoracic echocardiography (TTE) is used to guide TAVI procedures.

Early Acurate Neo transcatheter heart valve degeneration in a haemodialysis patient successfully managed with Sapien 3 Ultra: a case report.

Background: Aortic valve disease is the most prevalent valvular abnormality in the developed world and carries a high risk of morbidity and mortality. Transcatheter aortic valve replacement (TAVR) is favoured over open-heart surgery in high-risk patient categories and is increasingly used in lower-risk groups. End stage kidney disease (ESKD) is associated with premature calcific degeneration of bioprosthetic heart valves. Redo-TAVR requires meticulous pre-procedural planning to avoid the important risks of sinus sequestration and impaired coronary access. Transcatheter aortic valve replacement with the Acurate Neo transcatheter heart valve (THV) has been clinically available for a short time only and there are limited reports describing redo-TAVR in the Acurate Neo. Case summary: We present a case of early, rapid onset, structural valve degeneration in a Acurate Neo, supra-annular, self-expanding THV in a dialysis patient. The patient presented with chest pain and breathlessness 4 years after TAVR with a Acurate Neo for severe stenosis of a bicuspid aortic valve. Echocardiogram now showed severe stenosis of the THV and computed tomography revealed severe THV leaflet calcification but no pannus or leaflet thrombus. After careful pre-procedural planning a S3 Ultra balloon-expandable valve was selected and positioned relatively high to pin the first THV leaflets in a fully open position without compromising coronary artery flow or coronary access. Discussion: End stage kidney disease may cause rapid, calcific degeneration of TAVR valves leading to presentation with severe aortic stenosis. Redo-TAVR in the Acurate Neo THV with a Sapien 3 Ultra is feasible with careful pre-procedural planning to mitigate the risks of sinus sequestration and impaired coronary access.

Comparison of left ventricular with right ventricular rapid pacing on tamponade during TAVI.

BACKGROUND: Small studies have suggested left ventricular (LV) rapid pacing has similar safety and efficacy to conventional right ventricular (RV) rapid pacing in transcatheter aortic valve implantation (TAVI). However, there are limited data on the comparative rates of tamponade. The study compared the rate of cardiac tamponade between LV and RV-pacing during TAVI. METHODS: Between 2008 and 2021, 1226 consecutive patients undergoing transfemoral or transaxillary TAVI were included. 470(38.3%) patients had TAVI deployment with RV-pacing and 756(61.7%) with LV-pacing. The primary outcome was the frequency and cause of cardiac tamponade. Secondary outcomes included efficacy, procedure duration and crossover rates. RESULTS: There was a trend to less tamponade with LV-pacing, which did not reach statistical significance [11(2.3%) vs 11(1.5%);P = 0.27]. There was no significant difference in the frequency of tamponade due to annular tear [4(0.9%) vs 9(1.2%);P = 0.59] or LV free-wall perforation [1(0.2%) vs 2(0.3%);P = 0.86]. The frequency of tamponade due to RV perforation was significantly lower in the LV-pacing group [0 vs 6(2.3%);P < 0.005)]. Two patients with tamponade due to RV perforation required emergency sternotomy of whom one died. Deployment success was similar (99% vs 99.6%;P=NS). Procedure duration was shorter with LV-pacing (70 vs 80 mins;P < 0.005). Crossover to RV-pacing was low (0.9%). There were no embolizations caused by loss-of-capture in either group. CONCLUSIONS: LV-pacing appears equally efficacious and is associated with a lower risk of tamponade due to RV perforation caused by the temporary pacing wire. LV-pacing was not associated with an increased risk of tamponade due to LV free-wall perforation.

Postprocedural Radial Artery Compression Time In Chronic AnticoaguLated patients using StatSeal: The PRACTICAL-SEAL study.

BACKGROUND: Patients on uniterrupted chronic oral anticoagulation (OAC) therapy are at high-risk of bleeding during cardiac catheterization. We aimed to investigate the safety and efficacy of the StatSeal® disc for adjunct hemostasis in patients undergoing transradial coronary angiography under uninterrupted OAC therapy. METHODS: Patients who underwent transradial cardiac catheterization without interrupted OAC therapy were included in this study. RESULTS: Among 180 patients, 85 (47.2%) patients were on warfarin and 95 (52.8%) patients on novel oral anticoagulants (NOACs). Patients on NOACs were older (72.9 ± 9.6 versus 69.7 ± 10.8 years, P < 0.001) and had more atrial fibrillation/flutter (94.7% versus 62.4%, P < 0.001), whereas patients on Warfarin were more often women (43.5% versus 26.3%, P = 0.02) and had mechanical heart valves (27.1% versus 0%, P < 0.001). Intravenous unfractioned heparin (UFH) was administered in 96.5% of patients on warfarin (3799 ± 1342 units) and 93.7% patients on NOACs (4028 ± 1362 units), P = 0.27. There were no differences in terms of type and sheath size and the need for ad hoc coronary intervention. Time-to-first release of the hemostatic wristband was 56.2 ± 12.6 min and complete hemostasis was achieved in 71.1 ± 13.0 min, with shorter times among patients on NOACs (54.1 ± 11.7 and 58.5 ± 13.2 min, 68.9 ± 11.7 versus 73.6 ± 14.0 min, P = 0.02, for both). There were no significant differences in terms of bleeding. There was no radial artery occlusion among 112 participants who underwent color Doppler ultrasound. CONCLUSION: The present study shows that in patients undergoing transradial coronary angiogram under contemporary uninterrupted OAC therapy and periprocedural administration of UFH, the use of StatSeal® disc for adjunctive hemostasis was associated with short times to complete hemostasis.

Retrieval of Undeflatable Stent Balloon Using Laser Energy.

Percutaneous coronary intervention (PCI) is one of the most frequent non-surgical procedures performed worldwide. As any invasive procedure, PCI is accompanied by a low but still important risk of complications. One such very rare complication is when the angioplasty balloon cannot be deflated. We present a case of undeflatable balloon during chronic total occlusion PCI and we report a novel technique for balloon retrieval: using the Excimer light amplification by stimulated emission of radiation (Laser) coronary atherectomy device.

Calcification of coronary arteries and aortic valve and circulating a-klotho levels in patients with chronic kidney disease.

BACKGROUND: Evidence suggests that the anti-aging protein a-Klotho is a central modulator of mineral homeostasis. Circulating a-Klotho exerts endocrine activity and has been implicated in the process of vascular calcification, which is accelerated in patients with chronic kidney disease (CKD) and portends an unfavorable overall prognosis. However, the role of a-Klotho in this process remains unclear. The purpose of this study was to investigate the possible interaction between a-Klotho and the calcification of the aortic valve and coronary arteries in patients with CKD. METHODS: In this study we enrolled a total of 60 adult patients with CKD. Group 1 included 30 participants with CKD stage V and group 2 included 30 participants with CKD stage III. RESULTS: Participants in group 1 had lower levels of circulating a-Klotho compared to group 2 (390; 280-590 vs. 722; 501-897 pg/mL; P=0.001), were of younger age (55.5; 45-63 vs. 69; 62-74 years; P<0.001), had lower body mass index (25.6; 23.8-27.5 vs. 28.2; 25.7-31.1 kg/m2; P=0.036), higher serum phosphate (4.75; 4-5.6 vs. 3.35; 2.9-3.8 mg/dL; P<0.001), higher calcium-phosphate product (41; 35.1-49.2 vs. 31.5; 28.6-35 mg2/dL2; P<0.001), and higher parathyroid hormone (PTH) levels (28.4; 15-44.6 vs. 7.05; 4.3-10.2 pmol /L; P<0.001). CONCLUSIONS: No statistically significant difference was found between the two groups in terms of coronary arteries and aortic valve calcification. Calcitonin, PTH and phosphate were identified as predictors for circulating a-Klotho levels whereas, only hyperlipidemia was identified as predictor for coronary artery calcification. In conclusion, circulating a-Klotho is found to decrease with worsening CKD severity but no correlation was found between the levels of a-Klotho and severity of coronary arteries and aortic valve calcification.

Serum ST2 and hospitalization rates in Caucasian and African American outpatients with heart failure.

BACKGROUND: Limited data exist on the association between circulating suppression of tumorigenicity 2 (ST2) and recurrent hospitalizations and emergency department (ED) encounters in outpatients with heart failure (HF). In addition, data on ST2 in African American patients with HF are scarce. METHODS: We evaluated 307 outpatients with HF (age, 57 ±â€¯12 years; 64.2% men; 51.5% Caucasian, 45.6% African American; median ejection fraction, 35%; ischemic etiology, 41.4%). Median ST2 was 37.8 ng/mL (29.6-51.4). RESULTS: After a median of 3.1 years, there were 584 hospitalizations (224 for HF) and 335 ED visits (80 for HF). Patients (N = 176; 57.3%) with elevated (>35 ng/mL) ST2 had 2-fold higher hospitalization rates in adjusted models (rate ratio [RR] 1.97; 95% CI 1.38-2.82; P < 0.001), driven by 3.5-fold higher HF hospitalization rates (adjusted RR 3.56; 95% CI 1.69-7.49; P < 0.001). These associations persisted after adjusting for baseline B-type natriuretic peptide levels. Findings were similar for elevated ST2 and ED visit rates. Elevated ST2 was associated with the composite of death or HF hospitalization (109 patients; 3-year estimate: 35.4%); risk was 5-fold higher in the first 6 months but declined gradually. The higher hospitalization rates and composite endpoint risk associated with elevated ST2 was similar in African Americans and Caucasians. In landmark analyses in a subset of patients, 6-month (N = 112) and 12-month (N = 149) changes in ST2 levels from baseline added prognostic information. CONCLUSIONS: Elevated ST2 in outpatients with HF portends higher healthcare resources utilization and higher risk for accelerated disease progression, regardless of race, especially in the first 6 months.

Cardiomyopathy and Heart Failure in Patients With HIV Infection.

With the advent and widespread use of antiretroviral therapy (ART), the epidemiology of cardiomyopathy and heart failure (HF) associated with HIV infection is changing. Near-normal life expectancy in contemporary HIV-infected populations has been associated with prolonged exposure to increased cardiometabolic burden and chronic immune activation and systemic inflammation. Therefore, the pre-ART phenotype of HIV-associated cardiomyopathy with overt left ventricular systolic dysfunction and poor prognosis has been replaced over time by cardiomyopathy with a more insidious course, more frequent ischemic background, and highly prevalent left ventricular diastolic dysfunction. Patients with HIV are more prone to development of coronary artery disease and development of HF after myocardial infarction. The role of ongoing immune activation and systemic inflammation, despite highly active ART (HAART), appears to be central in this process. The role of HAART toxicity is controversial, as HAART itself appears to be protective for the development of HF, but recent data suggest that protease inhibitors might adversely affect the course of HIV-associated HF. Because of these unique features, the optimal therapeutic approach for HIV-associated cardiomyopathy remains unknown. The current therapeutic approaches are an extrapolation from noninfected populations. Importantly, the significance of the highly prevalent diastolic abnormalities among HIV-infected patients is not known. Therefore, further research is needed to identify its prognostic implications. Considering the prevalence of structural and functional cardiac abnormalities in HIV-infected persons and the lack of evidence on how to best screen and treat these patients, systematic research on this topic is a public health priority.

The EluNIRTM Ridaforolimus Eluting Coronary Stent System.

INTRODUCTION: First-generation drug-eluting stents (DES) were developed and indeed proved their superiority compared to bare-metal stent in minimizing neo-intimal hyperplasia and in-stent restenosis (ISR), overall, reducing target vessel revascularization (TVR). Newer-generation DES are characterized by thinner struts, more biocompatible and either durable, biodegradable or polymer-free surfaces, better device profile and refined drug elution. Area covered: The EluNIRTM (Medinol, Tel Aviv, Israel) Ridaforolimus Eluting Coronary Stent System is a new DES with unique properties. In this review, we highlight the special characteristics of the stent and summarize relevant clinical data. The EluNIRTM was studied in two clinical trials, the NIREUS trial and the larger, pivotal, BIONICS trial. These trials collectively provide data on the safety, performance, and efficacy of the device. Expert commentary: The newly FDA-approved EluNIRTM stent features an elastomeric durable polymer which elutes a novel drug, Ridaforolimus. The stent has thin struts with variable widths and a delivery catheter with a spring tip. These characteristics may explain the good angiographic and clinical results of this stent, which were noninferior to the FDA-approved Medtronic ResoluteTM stent DES.

Atrial septostomy and disease targeting therapy in pulmonary hypertension secondary to neurofibromatosis.

BACKGROUND: Neurofibromatosis type 1 (NF1) is a rare multisystem genetic disorder. During the course of the disease it can be rarely complicated with pulmonary hypertension (PH) which confers a dismal prognosis. CASE PRESENTATION: We describe the case of a 57-year-old female patient with NF1 complicated by severe precapillary PH despite dual disease-specific oral combination therapy. The patient was treated with initial atrial septostomy followed by administration of high-dose subcutaneous treprostinil with a favorable medium-term clinical and hemodynamic response. CONCLUSIONS: PH secondary to NF1 may be successfully treated with the combination of atrial septostomy and PH targeted therapy in selected patients.