Revascularization for claudication: Changing the natural history of a benign disease!

OBJECTIVE: The benign natural history of intermittent claudication was first documented in 1960 and has been reconfirmed in several subsequent studies. Excellent outcomes in patients with intermittent claudication can be achieved with exercise therapy and optimal medical management. Professional society guidelines have clearly stated that revascularization procedures should be performed only in patients with incapacitating claudication who have failed conservative therapy. Despite these guidelines, revascularization procedures, primarily percutaneous interventions, have been increasingly utilized in patients with claudication. Many of these patients are not even offered an attempt at medical therapy, and those who are often do not undergo a full course of treatment. Many studies document significant reintervention rates following revascularization, which are associated with increased rates of acute and chronic limb ischemia that may result in significant rates of amputation. The objectives of this study were to compare outcomes of conservative therapy to those seen in patients undergoing revascularization procedures and to determine the impact of revascularization on the natural history of claudication. METHODS: Google Scholar and PubMed were searched for manuscripts on the conservative management of claudication and for those reporting outcomes following revascularization for claudication. RESULTS: Despite early improvement in claudication symptoms following revascularization, multiple studies have demonstrated that long-term outcomes following revascularization are often no better than those obtained with conservative therapy. High reintervention rates (up to 43% for tibial atherectomies) result in high rates of both acute and chronic limb ischemia as compared with those patients undergoing medical therapy. In addition, amputation rates as high as 11% on long-term follow-up are seen in patients undergoing early revascularization. These patients also have a higher incidence of adverse cardiovascular events such as myocardial infarctions compared with patients treated medically. CONCLUSIONS: Revascularization procedures negatively impact the natural history of claudication often resulting in multiple interventions, an increase in the incidence of acute and chronic limb ischemia, and an increased risk of amputation. Accordingly, informed consent requires that all patients undergoing early revascularization must be appraised of the potential negative impact of revascularization on the natural history of claudication.

Mitral valve-in-valve with 4D intracardiac echocardiography: Procedural and imaging technique.

Transcatheter mitral valve-in-valve (ViV) has emerged as a safe and effective therapeutic option for patients with a degenerated mitral bioprosthesis. As procedural techniques mature and operator experience improve, there is a push to adopt a "minimalist" approach of using conscious sedation instead of general anesthesia for faster recovery. The heavy reliance on fluoroscopy for ViV deployment makes feasible the use of intracardiac echocardiography (ICE) instead of transesophageal echocardiography for other procedural imaging requirements. We hereby use a case example to illustrate a step-by-step approach of using four-dimensional ICE to guide transcatheter mitral ViV under conscious sedation.

The PIGTAIL paradigm for a fast and safe transfemoral transcatheter aortic valve replacement.

Transfemoral transcatheter aortic valve replacement is the preferred primary access route whenever possible. Despite advancements in expertise and delivery system profiles, complications associated with the primary femoral access still significantly affect procedural morbidity and outcomes. The current standard for accurate main access planning involves proper preprocedural evaluation guided by computed tomography. Several baseline clinical and anatomical features serve as predictors for the risk of vascular injury occurring during or after transcatheter aortic valve replacement. In this paper, we aimed at reviewing the most up-to-date knowledge of the topic for a safe transfemoral access approach according to a paradigm we have called "PIGTAIL."

Impact of transcatheter edge to edge repair in functional mitral regurgitation and cardiac resynchronization-therapy nonresponders.

BACKGROUND: Despite optimal medical therapy and cardiac resynchronization therapy (CRT), significant functional mitral regurgitation (MR) persisted in 30% of the patients and labeled as CRT nonresponders. AIMS: We sought to study the impact of transcatheter edge-to-edge repair (TEER) in patients with symptomatic grade III and IV functional MR despite CRT. METHODS: A retrospective analysis was conducted of all patients who had prior CRT for at least 6 months and underwent TEER for significant residual functional MR (grade ≥3) and symptomatic heart failure (HF) at our institution. The primary outcomes were the change in New York Heart Association classification (NYHA), MR grade, echo parameters, and NT-ProBNP from baseline to 1-year post-procedure. RESULTS: A total of 28 patients were identified, mean age of 73 ± 6.7 years and 89% males. Procedure success was achieved in all patients. At 1-year follow-up, patients had lower MR grade (median 2, IQR 1 [1,2] vs. 4, IQR 1 [3,4]; p < 0.001), NYHA class (median 2, IQR 1 [2,3] vs. 3, IQR 1 [3,4]; p < 0.001), and NT-ProBNP (7658 ± 11322 vs. 3760 ± 4431; p = 0.035) compared to before the TEER procedure. The left ventricular end-diastolic volume (255 ± 59 vs. 244 ± 66 mm; p = 0.016) and the right ventricular systolic pressure (52 ± 14 mmHg vs. 37 ± 13 mmHg, <0.001) decreased. CONCLUSION: Patients who remain symptomatic after CRT with severe functional MR had improved functional status and MR grade at 1-year following TEER. There was a signal toward reverse remodeling.

Ultrasound-guided deployment of ProGlide™ device in transfemoral transcatheter aortic valve implantation and risk reduction of vascular complications: A propensity-matched cohort study.

BACKGROUND: ProGlide is a percutaneous suture-mediated closure device used in arterial and venous closure following percutaneous intervention. Risk of vascular complications from use, particularly related to failure in hemostasis, or acute vessel closure, remains significant and often related to improper suture deployment. We describe a technique of ultrasound-guided ProGlide deployment in transfemoral transcatheter aortic valve implantation (TF-TAVI). AIMS: The aim of this study is to assess vascular outcomes for ultrasound-guided deployment of ProGlide vascular closure devices in patients undergoing TF-TAVI. METHODS: We collected relevant clinical data of patients undergoing TAVI in a large volume centre. PRIMARY OUTCOME: main access Valve Academic Research Consortium 3 (VARC-3) major vascular complication. SECONDARY OUTCOME: any major/minor VARC-3 vascular complication, its type (bleed or ischemia), and treatment required (medical, percutaneous, or surgical). We performed inverse weighting propensity score analysis to compare the population undergoing ultrasound-guided versus conventional ProGlide deployment for main TAVI access. Ultrasound technique for ProGlide insertion was performed as described below. RESULTS: Five hundred and seventeen patients undergoing TF-TAVI were included. PRIMARY OUTCOME: In 126 (ultrasound-guided) and 391 (conventional ProGlide insertion), 0% versus 1.8% (p < 0.001) had a major VARC-3 vascular complication, respectively. SECONDARY OUTCOME: 0.8% (one minor VARC-3 bleed) vs 4.1% (13 bleeds and three occlusions) had any VARC-3 vascular complication (major and minor) (p < 0.001). Surgical treatment of vascular complication was required in 0.8% versus 1.3% (p = NS). CONCLUSIONS: Ultrasound-guided deployment of ProGlide for vascular closure reduced the risk of major vascular complications in a large population undergoing TAVI.

Simplified balloon-BASILICA: A different perspective.

Nowadays, the long-life management of patients with aortic stenosis has emerged as one of the most debated issues. Transcatheter aortic valve replacement is more frequently performed in younger patients with lower surgical risk, and also the number of valve-in-valve (ViV) procedures has increased in the last few years. However, coronary obstruction is the most dreadful complication related to this procedure. To prevent coronary obstruction in the context of transcatheter aortic ViV implantation, the BASILICA (bioprosthetic or native aortic scallop intentional laceration to prevent iatrogenic coronary artery obstruction) technique was developed. Although effective, BASILICA is complex and time-consuming. Hence, simpler, reproducible, and faster strategies are desirable. Here we present a promising simplified BASILICA technique employing an Armada Balloon to perform the leaflet laceration.

Computed tomography derived anatomical predictors of vascular access complications following transfemoral transcatheter aortic valve implantation: A systematic review.

BACKGROUND: Vascular complications after percutaneous transfemoral transcatheter aortic valve implantation (TAVI) are associated with adverse clinical outcomes and remain a significant challenge. AIMS: The purpose of this review is to synthesize the existing evidence regarding the iliofemoral artery features predictive of vascular complications after TAVI on pre-procedural contrast-enhanced multidetector computed tomography (MDCT). METHODS: A systematic search was performed in Embase and Medline (Pubmed) databases. Studies of patients undergoing transfemoral TAVI with MDCT were included. Studies with only valve-in-valve TAVI, planned surgical intervention and those using fluoroscopic assessment were excluded. Data on study cohort, procedural characteristics and significant predictors of vascular complications were extracted. RESULTS: We identified 23 original studies involving 8697 patients who underwent TAVI between 2006 and 2020. Of all patients, 8514 (97.9%) underwent percutaneous transfemoral-TAVI, of which 8068 (94.8%) had contrast-enhanced MDCT. The incidence of major vascular complications was 6.7 ± 4.1% and minor vascular complications 26.1 ± 7.8%. Significant independent predictors of major and minor complications related to vessel dimensions were common femoral artery depth (>54 mm), sheath-to-iliofemoral artery diameter ratio (>0.91-1.19), sheath-to-femoral artery diameter ratio (>1.03-1.45) and sheath-to-femoral artery area ratio (>1.35). Substantial iliofemoral vessel tortuosity predicted 2-5-fold higher vascular risk. Significant iliofemoral calcification predicted 2-5-fold higher risk. The iliac morphology score was the only hybrid scoring system with predictive value. CONCLUSIONS: Independent iliofemoral predictors of access-site complications in TAVI were related to vessel size, depth, calcification and tortuosity. These should be considered when planning transfemoral TAVI and in the design of future risk prediction models.

Transcatheter pulmonary valve replacement in surgically-created double-barrel right ventricular outflow tracts: A single center case-series.

This manuscript describes the feasibility and approach to the assessment and performance of transcatheter pulmonary valve replacement (tPVR) in patients with surgically-created "double-barrel" right ventricular outflow tracts (RVOT). Patients with tetralogy of Fallot may have coronary anomalies which prohibit the performance of traditional tetralogy of Fallot repair. In certain cases, this may necessitate the placement of a right ventricle to pulmonary artery conduit in addition to the native RVOT, which is left in situ, creating so-called "double-barrel" RVOTs. When these patients develop RVOT dysfunction later in life, they would typically be referred for reoperation due to concerns for risk of coronary compression associated with a transcatheter approach. However, whether a transcatheter approach with valve replacement in the native RVOT is feasible or safe is unknown. This was a retrospective review of patients with a surgically created "double-barrel" RVOTs who underwent cardiac catheterization for assessment of tPVR at Boston Children's Hospital. From July 2012 to July 2022, there were four patients with "double-barrel" RVOTs who underwent assessment for tPVR. The age at catheterization ranged between 22 and 39 years. In three out of four patients, coronary compression testing was negative. These three patients had successful tPVR in the native RVOT. At follow up, all three patients were free of greater than mild regurgitation by echocardiogram and had a maximum instantaneous gradient across the RVOT ranging between 20 and 33 mmHg. Performance of tPVR in patients with surgically created "double-barrel" RVOTs is feasible. The safety of this procedure depends crucially on coronary artery assessment at all stages.

Long-term function of a novel autologous transcatheter pulmonary heart valve implant in an adult animal model.

BACKGROUND: Current heart valve implants entail major disadvantages in the treatment for younger patients or those with congenital heart defects. AIM: Evaluation of novel transcatheter pulmonary valve implant made from autologous pericardium with natural crosslinking agent in an in vitro setup and in vivo animal model METHODS: Valves were tested in a pulse duplicator according to ISO-standard 5840. For in vivo studies computer tomography was performed to measure sheep's native pulmonary valve dimensions. Pericardium was harvested by thoracotomy, personalized implants were manufactured and deployed in pulmonary valve position of the same sheep. Every 3 months implant functionality was evaluated by intracardiac echocardiography, intracardiac pressure measurements and cardiac magnetic resonance imaging (cMRI). Implants were explanted for macroscopic and histological examination. RESULTS: In vitro experiments showed compliance with regulatory requirements in terms of valve opening and insufficiency. Five sheep successfully received an autologous valve implant. Two animals had to be euthanized due to trauma sustained in the stable. Long-term valve function was excellent in three out of four animals with median implant cMRI regurgitation fraction of 9% (n = 4) at 3 months, 8% (n = 3) at 6, 8% (n = 3) at 9, 12% (n = 3) at 13, 8% (n = 2) at 17% and 8% (n = 2) at 20.5 months after implantation. Despite good adherence to neighboring tissue and endothelization, histological assessment revealed some signs of degeneration. CONCLUSION: Transcatheter pulmonary valve implants showed promising function for up to 20.5 months encouraging research to further improve this approach.

Recurrent hypo-attenuated leaflet thickening after TAVR: Clinical implications.

Subclinical bioprosthetic valve thrombosis (BPVT) is a relatively common finding in asymptomatic patients during follow-up imaging. However, its clinical significance is unclear. Data from registries associate BPVT with elevated valve gradients, thromboembolic complications, recurrence, and valve degeneration. Given the dynamic nature of the disease process, management is challenging. The duration of anticoagulation is unpredictable, and the need for frequent monitoring of BPVT, even in subclinical scenarios, is unclear. Our report is shedding the light on the clinical implications BPVT.

Outcomes and relevance of emergency percutaneous coronary angiography and intervention after resuscitated cardiac arrest: a retrospective study.

BACKGROUND: In patients resuscitated from cardiac arrest and displaying no ST-segment elevation on initial electrocardiogram (ECG), recent randomized trials indicated no benefits from early coronary angiography. How the results of such randomized studies apply to a real-world clinical context remains to be established. METHODS: We retrospectively analyzed a clinical database including all patients 18 yo or older admitted to our tertiary University Hospital from January 2017 to August 2020 after successful resuscitation of out-of-Hospital (OHCA) or In-Hospital (IHCA) cardiac arrest of presumed cardiac origin, and undergoing immediate coronary angiography, regardless of the initial rhythm and post-resuscitation ECG. The primary outcome of the study was survival at day 90 after cardiac arrest. Demographic data, characteristics of cardiac arrest, duration of resuscitation, laboratory values at admission, angiographic data and revascularization status were collected. Comparisons were performed according to the initial ECG (ST-segment elevation or not), and between survivors and non-survivors. Variables associated with the primary outcome were evaluated by univariate and multivariate regression analyses. RESULTS: We analyzed 147 patients (130 OHCA and 17 IHCA), including 67 with STEMI and 80 without STEMI (No STEMI). Immediate revascularization was performed in 65/67 (97%) STEMI and 15/80 (19%) no STEMI. Day 90 survival was significantly higher in STEMI (48/67, 72%) than no STEMI (44/80, 55%). In the latter patients, survival was not influenced by the revascularization status. In univariate and multivariate analyses, lower age, a shockable rhythm, shorter durations of no flow and low flow, and a lower initial blood lactate were associated with survival in both STEMI and no STEMI. In contrast, metabolic abnormalities, including lower initial plasma sodium and higher potassium were significantly associated with mortality only in the subgroup of no STEMI patients. CONCLUSIONS: Our results, obtained in a real-world clinical setting, indicate that an immediate coronary angiography is not associated with any survival advantage in patients resuscitated from cardiac arrest of presumed cardiac etiology without ST-segment elevation on initial ECG. Furthermore, we found that some early metabolic abnormalities may be associated with mortality in this population, which should deserve further investigation.

Three-dimensional transesophageal echocardiography measurements of ASD sizing parameters in comparison to balloon sizing method in percutaneous ASD closure.

BACKGROUND: Balloon sizing (BS) has been used for device size selection in percutaneous atrial septal defect (ASD) closure. Due to its limitations, alternative imaging techniques like three-dimensional transesophageal echocardiography (3D-TEE) are valuable for guiding ASD device size selection during ASD closure procedures. The purpose of this study was to compare ASD sizing using measurements obtained from 3D-TEE to those utilizing the standard balloon sizing method. METHODS: We identified 53 patients with single secundum type ASD without PFO who underwent percutaneous closure at the Tehran Heart Center between 2019 and 2022. Balloon sizing was performed in all patients with the stop-flow technique, and the choice of device size was determined based on the sizing derived from BS. 3D-TEE imaging was performed before the intervention, and the ASD shape and quality of ASD rims were assessed. RESULTS: Among the 53 patients who underwent single ASD device closure, multiple 3D TEE measurements significantly correlated with balloon sizing results. This included defect area, perimeter, and diameter obtained from 3D-TEE images multi-planar reconstruction. ASD perimeter detected by 3D TEE had the best correlation with BS results. When divided by the shape of ASD, there was no significant difference between our 3D-images data and BS in round or oval-shaped ASDs. CONCLUSION: The 3D-TEE study is reliable for assessing ASD configurational characteristics in percutaneous device closure candidates. 3D-TEE has the potential to accurately determine the appropriate device size and reduce complications, costs, and procedural duration. Further research is needed to validate these findings and establish the role of 3D-TEE measurements in guiding the best treatment decisions for ASD closure.

The effects of percutaneous branch pulmonary artery interventions on exercise capacity, lung perfusion, and right ventricular function in biventricular CHD: a systematic review.

BACKGROUND: Branch pulmonary artery stenosis is common after surgical repair in patients with biventricular CHD and often requires reinterventions. However, (long-term) effects of percutaneous branch pulmonary artery interventions on exercise capacity, right ventricular function, and lung perfusion remain unclear. This review describes the (long-term) effects of percutaneous branch pulmonary artery interventions on exercise capacity, right ventricular function, and lung perfusion following PRISMA guidelines. METHODS: We performed a systematic search in PubMed, Embase, and Cochrane including studies about right ventricular function, exercise capacity, and lung perfusion after percutaneous branch pulmonary artery interventions. Study selection, data extraction, and quality assessment were performed by two researchers independently. RESULTS: In total, 7 eligible studies with low (n = 2) and moderate (n = 5) risk of bias with in total 330 patients reported on right ventricular function (n = 1), exercise capacity (n = 2), and lung perfusion (n = 7). Exercise capacity and lung perfusion seem to improve after a percutaneous intervention for branch pulmonary artery stenosis. No conclusions about right ventricular function or remodelling, differences between balloon and stent angioplasty or specific CHD populations could be made. CONCLUSION: Although pulmonary artery interventions are frequently performed in biventricular CHD, data on relevant outcome parameters such as exercise capacity, lung perfusion, and right ventricular function are largely lacking. An increase in exercise capacity and improvement of lung perfusion to the affected lung has been described in case of mild to more severe pulmonary artery stenosis during relatively short follow-up. However, there is need for future studies to evaluate the effect of pulmonary artery interventions in various CHD populations.

Positive association between stress hyperglycemia ratio and pulmonary infection in patients with ST-segment elevation myocardial infarction undergoing percutaneous coronary intervention.

BACKGROUND: Previous studies have shown that the stress hyperglycemia ratio (SHR), a parameter of relative stress-induced hyperglycemia, is an excellent predictive factor for all-cause mortality and major adverse cardiovascular events (MACEs) among patients with ST-segment elevation myocardial infarction (STEMI). However, its association with pulmonary infection in patients with STEMI during hospitalization remains unclear. METHODS: Patients with STEMI undergoing percutaneous coronary intervention (PCI) were consecutively enrolled from 2010 to 2020. The primary endpoint was the occurrence of pulmonary infection during hospitalization, and the secondary endpoint was in-hospital MACEs, composed of all-cause mortality, stroke, target vessel revascularization, or recurrent myocardial infarction. RESULTS: A total of 2,841 patients were finally included, with 323 (11.4%) developing pulmonary infection and 165 (5.8%) developing in-hospital MACEs. The patients were divided into three groups according to SHR tertiles. A higher SHR was associated with a higher rate of pulmonary infection during hospitalization (8.1%, 9.9%, and 18.0%, P < 0.001) and in-hospital MACEs (3.7%, 5.1%, and 8.6%, P < 0.001). Multivariate logistic regression analysis demonstrated that SHR was significantly associated with the risk of pulmonary infection during hospitalization (odds ratio [OR] = 1.46, 95% confidence interval [CI] 1.06-2.02, P = 0.021) and in-hospital MACEs (OR = 1.67, 95% CI 1.17-2.39, P = 0.005) after adjusting for potential confounding factors. The cubic spline models demonstrated no significant non-linear relationship between SHR and pulmonary infection (P = 0.210) and MACEs (P = 0.743). In receiver operating characteristic curve, the best cutoff value of SHR for pulmonary infection was 1.073. CONCLUSIONS: The SHR is independently associated with the risk of pulmonary infection during hospitalization and in-hospital MACEs for patients with STEMI undergoing PCI.

Impact of frailty on outcomes in acute ST-elevated myocardial infarctions undergoing percutaneous coronary intervention.

AIMS: We analyzed the impact of frailty on readmission rates for ST-elevated myocardial infarctions (STEMIs) and the utilization of percutaneous coronary intervention (PCI) in STEMI admissions. METHODS AND RESULTS: The 2016-2019 Nationwide Readmission Database was analyzed for patients admitted with an acute STEMI. Patients were categorized by frailty risk and analyzed for 30-day readmission risk after acute STEMIs, PCI utilization and outcomes, and healthcare resource utilization. Qualifying index admissions were found in 584,918 visits. Low risk frailty was noted in 78.20%, intermediate risk in 20.67%, and high risk in 1.14% of admissions. Thirty-day readmissions occurred in 7.74% of index admissions, increasing with frailty (p < 0.001). Readmission risk increased with frailty, 1.37 times with intermediate and 1.21 times with high-risk frailty. PCI was performed in 86.40% of low-risk, 66.03% of intermediate-risk, and 58.90% of high-risk patients (p < 0.001). Intermediate patients were 55.02% less likely and high-risk patients were 61.26% less likely to undergo PCI (p < 0.001). Length of stay means for index admissions were 2.96, 7.83, and 16.32 days for low, intermediate, and high-risk groups. Intermediate and high-risk frailty had longer length of stay, higher total cost, and were more likely to be discharged to a skilled facility (p < 0.001). CONCLUSION: Among adult, all-payer inpatient visits, frailty discerned by the hospital frailty risk score was associated with increased readmissions, increased healthcare resource utilization, and lower PCI administration.

Prognostic impact of coronary lesions and its revascularization in a 5-year follow-up after the TAVI procedure.

BACKGROUND: Coronary artery disease (CAD) is a common finding in patients undergoing transcatheter aortic valve implantation (TAVI). However, its prognostic significance and its management remains controversial. AIMS: This study sought to determine whether the presence of CAD, its complexity, and angiography-guided percutaneous coronary intervention (PCI) are associated with outcomes after TAVI. METHODS: All patients undergoing TAVI at a tertiary referral center between 2008 and 2018 were included in a prospective observational study. Baseline SYNTAX (Synergy between PCI with Taxus and Cardiac Surgery) score (SS) and a residual SS after PCI were calculated. The endpoints on the 5 year follow-up were all-cause mortality and a composite of mayor cardiovascular adverse events (MACE). RESULTS: In 379 patients, the presence of CAD and its complexity were not significantly associated with worse 5-year survival after TAVI, with a mortality for SS0 of 45%; for SS 1-22 of 36.5% (HR 0.77; 95% CI 0.53-1.11, p = 0.15) and for SS > 22 of 42.1% (HR 1.24; 95% CI 0.59-2.63, p = 0.57). Regarding the combined event of MACE, there were also no statistically significant differences between patients with CAD and without CAD (56.8% in patients without CAD and 54.9% in patients with CAD; HR 1.06; 95% CI 0.79-1.43, p = 0.7). Angiography-guided PCI or completeness of revascularization was not associated with different outcomes. CONCLUSIONS: In the present analysis, neither the presence nor the extent of CAD, nor the degree of revascularization, was associated with a prognostic impact in patients undergoing TAVI at 5-year follow-up.

Keeping it in the family: Use of the grandmother, mother, and child technique to navigate complex anatomy during Coronary sinus Reducer Implantation.

The Coronary Sinus Reducer® (CSR) is an emerging therapy for refractory angina recommended once no further pharmacologic or coronary revascularization options are available. We present the case of a 72-year-old man who underwent CSR implantation. Complex coronary sinus anatomy necessitated an innovative "grandmother, mother, and child" catheter approach.

PRIME score for prediction of permanent pacemaker implantation after transcatheter aortic valve replacement.

OBJECTIVES: We sought to produce a simple scoring system that can be applied at clinical visits before transcatheter aortic valve replacement (TAVR) to stratify the risk of permanent pacemaker (PPM) after the procedure. BACKGROUND: Atrioventricular block is a known complication of TAVR. Current models for predicting the risk of PPM after TAVR are not designed to be applied clinically to assist with preprocedural planning. METHODS: Patients undergoing TAVR at the University of Colorado were split into a training cohort for the development of a predictive model, and a testing cohort for model validation. Stepwise and binary logistic regressions were performed on the training cohort to produce a predictive model. Beta coefficients from the binary logistic regression were used to create a simple scoring system for predicting the need for PPM implantation. Scores were then applied to the validation cohort to assess predictive accuracy. RESULTS: Patients undergoing TAVR from 2013 to 2019 were analyzed: with 483 included in the training cohort and 123 included in the validation cohort. The need for a pacemaker was associated with five preprocedure variables in the training cohort: PR interval > 200 ms, Right bundle branch block, valve-In-valve procedure, prior Myocardial infarction, and self-Expandable valve. The PRIME score was developed using these clinical features, and was highly accurate for predicting PPM in both the training and model validation cohorts (area under the curve 0.804 and 0.830 in the model training and validation cohorts, respectively). CONCLUSIONS: The PRIME score is a simple and accurate preprocedural tool for predicting the need for PPM implantation after TAVR.

Novel arm-width-expandable transcatheter edge-to-edge repair system: Preclinical experiment and first-in-human study.

BACKGROUND: The ValveClasp system is a novel transcatheter edge-to-edge repair (TEER) device with an arm-width-expandable clip that allows treatment of patients with only one clip more frequently. OBJECTIVES: This study aimed to evaluate the feasibility and safety of a novel TEER device in porcine models and patients. METHODS: Fourteen young adult pigs were enrolled. A clip with an expanded arm was implanted under epicardial echocardiography and fluoroscopy guidance. Five patients with at least moderate-to-severe mitral regurgitation underwent TEER using the ValveClasp system to test the safety and effectiveness of the device. RESULTS: The device success rate was 100% (14/14) in the animal experiments, and all clips were deployed at the A2P2 segments, forming a double-orifice mitral valve. Gross observations on day 180 showed a wide and continuous tissue bridge between the leaflets. The acute procedural success rate was 100% (5/5). Only one clip was required in all patients, and all achieved effective postoperative endpoints (grade ≤2+). During 30-day follow-up, no adverse events occurred. All patients' vena Contracta width (from 8.04 0.71 mm to 3.84 ± 1.18 mm, p = 0.012), mitral regurgitation area (from 12.75 ± 3.13 cm2 to 3.50 ± 1.66 cm2 , p = 0.008), and left ventricular end diastolic diameter (from 52.00 ± 2.92 mm to 46.00 ± 3.08 mm, p = 0.040) were considerably decreased, without obvious mitral stenosis. CONCLUSIONS: The novel arm-width-expandable ValveClasp device is safe for TEER for treating severe mitral regurgitation.

Successful closure of transcatheter aortic valve replacement-induced Gerbode defect with valve-in-valve technique: A case report.

We present the first documented case of a successful closure of a transcatheter aortic valve replacement (TAVR)-induced Gerbode defect using a valve-in-valve approach. A 90-year-old female with severe aortic stenosis underwent TAVR. Following post-dilatation, the patient experienced hemodynamic deterioration and collapse due to tamponade and sub-annular rupture leading to hemodynamic deterioration and the development of a Gerbode defect with communication between the left ventricle and right atrium. Hemodynamic stabilization was achieved through pericardiocentesis, followed by the low implantation of a second valve, effectively sealing the rupture. This case showcases a valuable alternative for managing rare challenging complications during TAVR procedures.