Tafamidis 61 mg Patient Characteristics and Persistency? A Retrospective Analysis of German Statutory Health Insurance Data (IQVIA™ LRx).

INTRODUCTION: Tafamidis is the first drug approved by the European Commission for the treatment of wild-type or hereditary transthyretin amyloid cardiomyopathy (ATTR-CM) in adults to reduce cardiovascular mortality and cardiovascular-related hospitalization. Real-world treatment patterns of tafamidis 61 mg in Germany are not well studied in patients with ATTR-CM. METHODS: This was a non-interventional, retrospective, observational cohort study of adult patients in Germany based on the IQVIA pharmacy claims database (IQVIA™ LRx). Patients included in the analysis were statutory insured and received at least one prescription of tafamidis 61 mg between March 1, 2020 and August 31, 2022. Treatment adherence was analyzed using the modified medical possession ratio (mMPR) and proportion of days covered (PDC). RESULTS: Overall, 1565 adult patients received at least one tafamidis prescription in the study period. Their mean age was 78.3 years, 82.4% were male, and 23.2% were treated by a cardiologist. Persistency rates for patients treated with tafamidis 61 mg were high: 78.0% for 12 months and 65.1% for 24 months after treatment initiation. Patients also had high adherence rate on filling their prescriptions on time: 94.6% and 90.5% of patients had adherence rates of at least 80%, measured by mMPR and PDC, respectively. CONCLUSIONS: In the IQVIA™ LRx database, patients prescribed tafamidis 61 mg in Germany displayed high adherence and persistency rates, which suggest good drug tolerability and ease of use.

Epicardial ventricular tachycardia ablation: safety and efficacy of access and ablation using low-iodine content.

BACKGROUND: Epicardial ablation has become an integral part of the treatment of ventricular tachycardias (VT). This study reports the safety of epicardial access as well as the efficacy of epicardial ablation of structural heart disease in a tertiary single-center experience. METHODS: Between January 2016 and February 2022, consecutive patients undergoing an epicardial access for VT ablation were included. Different puncture techniques and occurrence of epicardial access-related complications as well as the safety of ablation using non-ionic 5% dextrose in water (D5W) compared to standard 0.9% normal saline (NS) irrigation were analyzed. VT recurrence rates during a mean follow-up of 37 ± 23 months were reported. RESULTS: In total, 197 patients undergoing a total of 239 procedures were included (59.8 ± 15.3 years, 86% males). A total of 154 patients (78%) had non-ischemic cardiomyopathies with a mean LVEF of 37 ± 14. Anterior-oriented epicardial access was aimed for in all cases and was successful in 217 (91%) of all procedures, whereas access was achieved in 19 procedures (8%) only using an inferior oriented access and in three procedures (1%) using surgical access due to severe adhesions or anatomical requirements. Overall epicardial puncture-related complications occurred in 18 (8%) of all procedures with minor pericardial bleeding in nine, pericardial tamponade in one, pneumothorax in five, pneumopericardium in one, and abdominal puncture in two cases. Presence of adhesions could be identified as the only independent predictor of epicardial access-related complications. D5W was used in 79 cases and regular 0.9% saline in 117 procedures. No differences were seen regarding acute ablation success or complications. During follow-up, 47% of all patients were free from any VTs (56% D5W vs. 40% NS; log-rank p = 0.747) and 92% of clinical VTs (98% D5W vs. 91% NS; log-rank p = 0.139). CONCLUSIONS: In this large single-centre experience, epicardial access and ablation were safe and feasible. Although long-term clinical VT recurrence rates were low, overall VT recurrences as well as mortality were high advocating for a highly experienced, interdisciplinary approach including intense management of underlying cardiac disease/heart failure. Routine usage of D5W was safe and associated with comparable short- or long-term clinical or overall VT freedom.

Transapical Mitral Valve Replacement: 1-Year Results of the Real-World Tendyne European Experience Registry.

BACKGROUND: Early studies of the Tendyne transcatheter mitral valve replacement (TMVR) showed promising results in a small selective cohort. OBJECTIVES: The authors present 1-year data from the currently largest commercial, real-world cohort originating from the investigator-initiated TENDER (Tendyne European Experience) registry. METHODS: All patients from the TENDER registry eligible for 1-year follow-up were included. The primary safety endpoint was 1-year cardiovascular mortality. Primary performance endpoint was reduction of mitral regurgitation (MR) up to 1 year. RESULTS: Among 195 eligible patients undergoing TMVR (median age 77 years [Q1-Q3: 71-81 years], 60% men, median Society of Thoracic Surgeons Predicted Risk of Mortality 5.6% [Q1-Q3: 3.6%-8.9%], 81% in NYHA functional class III or IV, 94% with MR 3+/4+), 31% had "real-world" indications for TMVR (severe mitral annular calcification, prior mitral valve treatment, or others) outside of the instructions for use. The technical success rate was 95%. The cardiovascular mortality rate was 7% at 30 day and 17% at 1 year (all-cause mortality rates were 9% and 29%, respectively). Reintervention or surgery following discharge was 4%, while rates of heart failure hospitalization reduced from 68% in the preceding year to 25% during 1-year follow-up. Durable MR reduction to ≤1+ was achieved in 98% of patients, and at 1 year, 83% were in NYHA functional class I or II. There was no difference in survival and major adverse events between on-label use and "real-world" indications up to 1 year. CONCLUSIONS: This large, real-world, observational registry reports high technical success, durable and complete MR elimination, significant clinical benefits, and a 1-year cardiovascular mortality rate of 17% after Tendyne TMVR. Outcomes were comparable between on-label use and "real-world" indications, offering a safe and efficacious treatment option for patients without alternative treatments. (Tendyne European Experience Registry [TENDER]; NCT04898335).

Sex-Specific Disparities in Outcomes of Transcatheter Edge-to-Edge Repair for Mitral Regurgitation: A Multicenter "Real-World" Analysis.

BACKGROUND: mitral regurgitation (mr) is the most common valvular heart disease (vhd) in the elderly and tends to be more prevalent in women. while relevant sex differences in outcomes are evident in surgically treated collectives, there are very limited and conflicting sex-specific data for the growing cohort of patients undergoing transcatheter edge-to-edge repair (teer). OBJECTIVE: to investigate whether sex impacts procedural safety and efficacy, and in-hospital- and long-term outcomes, after teer for mr. METHODS: in a multicenter observational cohort study, patients who underwent teer were stratified by sex and relevant outcome measures, and analyzed using multivariable cox regression and propensity score matching (psm). RESULTS: a total of 821 patients were analyzed, of whom 37.4% (307/821) were female. compared to male patients, females were significantly older (77 ± 8.5 vs. 80.4 ± 6.7 years, p = 0.03), and had less coronary artery disease (cad, 67.7% vs. 53.1%, p < 0.0001) and a higher proportion of preserved left ventricular function (lvef > 50%, 32.5% vs. 50.5%, p > 0.0001). safety and efficacy of the teer procedure and in-hospital mortality did not differ between the sexes. after psm, women showed significantly better survival 3 years after teer compared to men (60.7% vs. 54.2%, p = 0.04) and a lower risk of all-cause death according to multiple cox regression (hr 0.8, 95% ci 0.6-0.9, p = 0.02). after sex-specific stratification for concomitant atrial fibrillation (af), the most common comorbidity in the present collective, women with af experience significantly worse adjusted survival compared to women without af (53.9% vs. 75.1%, p = 0.042) three years after teer and lose the survival advantage over men. CONCLUSIONS: female patients are older and less comorbid than males undergoing TEER. The TEER procedure is equally safe and effective in both sexes. While in-hospital mortality did not differ, female patients experienced a significantly better adjusted long-term survival compared to male patients. Concomitant AF offsets the prognostic advantage of females over males and, in contrast to males, significantly impairs long-term survival in women undergoing TEER. Further research is warranted to elucidate underlying causes for the observed sex disparities and to develop sex-tailored treatment recommendations.

Recurrent Atrial Fibrillation Ablation after Initial Successful Pulmonary Vein Isolation.

BACKGROUND: Pulmonary vein isolation (PVI) is an effective treatment option for patients with symptomatic atrial fibrillation (AF). However, the electrical recovery of pulmonary veins (PVs) is the main trigger for AF recurrences. This study investigates the characteristics of patients admitted for redo AF ablation, the PV reconnection rates depending on previous ablation modalities and the impact of different ablation strategies for redo procedures. METHODS: Consecutive patients undergoing first redo AF ablation were included. Patients were grouped according to the electrical recovery of at least one PV. The impacts of the technique for first AF ablation on PV reconnection rates and patients with and without PV reconnection were compared. Different ablation strategies for redo procedures were compared and its recurrence rates after a mean follow-up of 25 ± 20 months were investigated. RESULTS: A total of 389 patients (68 ± 10 years; 57% male; 39% paroxysmal AF) underwent a first redo. The median time between the first and redo procedure was 40 ± 39 months. Radiofrequency was used in 278 patients, cryoballoon was used in 85 patients and surgical AF ablation was performed on 26 patients. In total, 325 patients (84%) had at least one PV reconnected, and the mean number of reconnected PVs was 2.0 ± 1.3, with significant differences between ablation approaches (p for all = 0.002); this was mainly due to differences in the left inferior PV and right superior PV reconnections. The presence of PV reconnection during redo was not associated with better long-term success compared to completely isolated PVs (67% vs. 67%; log-rank p = 0.997). Overall, the different ablation strategies for redos were comparable regarding AF recurrences during follow-up (p = 0.079), with the ablation approach having no impact in the case of left atrial low voltage or without. CONCLUSIONS: PV reconnections after initial successful PVI are common among all techniques of AF ablation. Long-term rhythm control off antiarrhythmic drugs was possible in 2/3 of all patients after the redo procedure; however, different ablation strategies with extra-PV trigger ablation did not improve long-term success. Patients with recurrent AF after PVI constitute a challenging group of patients.

Prognostic benefits of early vascular surgical intervention in patients with major peripheral vascular complications following transcatheter aortic valve implantation.

OBJECTIVES: This study aimed to analyze the incidence, surgical management of major vascular complications, and outcomes in patients undergoing transfemoral (TF) transcatheter aortic valve replacement (TAVR) at our center after strict selection of the access route, carefully considering all known major predictors. METHODS: Data of 494 consecutive patients with pre-interventional multi-slice computed tomography (CT) of the aorta who had undergone TF TAVR from 2009 to 2019 were analyzed. RESULTS: In total, 23/494 (4.7%) patients had major vascular and access-related complications of peripheral vessels and/or infrarenal aorta. These included hematomas that met the Valve Academic Research Consortium 3-criteria of major vascular complications (7/494, 1.4%), arterial dissections (3/494, 0.6%), pseudoaneurysm (6/494, 1.2%), thrombus of the external iliac artery leading to acute limb ischemia (1/494, 0.2%), fistula (1/494, 0.2%), and perforation (5/494, 1.0%). In total, 17/23 (73.9%) major vascular complications required immediate endovascular and/or open surgery. In 16/17 (94%) cases, only 1 surgical procedure was performed. The long-term survival of patients with and without major vascular complications of the peripheral vessels was determined after 2 years. CONCLUSIONS: Early vascular surgery intervention reversed the mortality disadvantage in patients with major complications of the peripheral vessels after TAVR. This underscores the importance of immediate vascular surgery stand-by as an indispensable requirement.

Catheter ablation of concomitant atrial fibrillation improves survival of patients undergoing transcatheter edge-to-edge mitral valve repair.

Background: Atrial fibrillation (AF) is the most common concomitant disease in patients undergoing transcatheter edge-to-edge repair (TEER) for mitral regurgitation (MR) and detrimentally affects their outcome. While there is increasing evidence for prognostic improvement and safety of catheter ablation (CA) of AF in the overall cohort of heart failure patients, corresponding data in TEER patients are lacking. Objectives: To investigate the impact of treatment regimens for concomitant AF on survival of TEER patients. Methods: In a multicenter observational cohort study consecutive patients successfully undergoing TEER were analyzed and survival of patients receiving CA of concomitant AF was compared with that of patients on pharmacological AF treatment and with that of patients without a history of AF, using propensity score matching (PSM). Results: A total of 821 patients were analyzed. Of these, 608 (74.1%) had concomitant AF, of whom 48 patients received CA. Patients with CA in AF showed significantly higher 3-year-survival after TEER compared to PSM-patients on pharmacological AF treatment (75.5% [36/48] vs. 49.4% [166/336], p = 0.009). The 3-year-survival after TEER of patients with concomitant AF treated with CA was not significantly different from PSM-patients without AF (75.5% [36/48] vs. 68.3% [98/144], p = 0.36). Conclusions: CA of AF is superior to pharmacotherapy as it significantly improves the survival of TEER patients in a PSM analysis. CA even offsets the prognostic disadvantage of coexisting AF in TEER patients. Given the growing evidence of prognostic benefits in the overall cohort of HF patients, our data point out the importance of treating concomitant AF and support CA as an essential part of a holistic management of TEER patients.

Electrical Storm Has Worse Prognosis Compared to Sustained Ventricular Tachycardia after VT Ablation.

BACKGROUND: Electrical storm (ES) represents a serious heart rhythm disorder. This study investigates the impact of ES on acute ablation success and long-term outcomes after VT ablation compared to non-ES patients. METHODS: In this large single-centre study, patients presenting with ES and undergoing VT ablation from June 2018 to April 2021 were compared to patients undergoing VT ablation due to ventricular tachyarrhythmias but without ES. The primary prognostic outcome was VT recurrence, and secondary endpoints were rehospitalization rates and cardiovascular mortality, all after a median follow-up of 22 months. RESULTS: A total of 311 patients underwent a first VT ablation due to ventricular tachyarrhythmias and were included (63 ± 14 years; 86% male). Of these, 108 presented with ES. In the ES cohort, dilated cardiomyopathy as underlying heart disease was significantly higher (p = 0.008). Major complications were equal across both groups (all p > 0.05). Ablation of the clinical VT was achieved in 94% of all patients (p > 0.05). Noninducibility of any VT was achieved in 91% without ES and in 76% with ES (p = 0.001). Patients with ES revealed increased VT recurrence rates during follow-up (65% vs. 40%; log rank p = 0.001; HR 1.841, 95% CI 1.289-2.628; p = 0.001). Furthermore, ES patients suffered from increased rehospitalization rates (73% vs. 48%; log rank p = 0.001; HR 1.948, 95% CI 1.415-2.682; p = 0.001) and cardiovascular mortality (18% vs. 9%; log rank p = 0.045; HR 1.948, 95% CI 1.004-3.780; p = 0.049). After multivariable adjustment, ES was a strong independent predictor of VT recurrence and rehospitalization rates, but not for mortality. In a propensity score-matched cohort, patients with ES still had a higher risk of VT recurrences and rehospitalizations compared to non-ES patients. CONCLUSIONS: VT ablation in patients with ES is challenging and these patients reveal the highest risk for recurrent VTs, rehospitalization and cardiovascular mortality. These patients need close follow-ups and optimal guideline-directed therapy.

Acute oesophageal safety and long-term follow-up of AI-guided high-power short-duration with 50 W for atrial fibrillation ablation.

AIMS: Pulmonary vein isolation using radiofrequency ablation is an effective treatment option for patients with symptomatic atrial fibrillation (AF). Application of high power over a short period of time (HPSD) is reported to create more efficient lesions and may prevent collateral thermal oesophageal injury. This study aims to compare efficacy and safety of two different HPSD ablation approaches using different ablation index settings. METHODS AND RESULTS: Consecutive patients undergoing AF ablation with HPSD (50 W; ablation index-guided) using the ThermoCool SmartTouch SF catheter were included. Patients were grouped by ablation protocol: ablation with target ablation index (AI) of 400 on the anterior left atrial wall vs. 300 at the posterior left atrial wall (AI 400/300) or AI 450/350 was performed upon the operator's preference and compared. Peri-procedural parameters and complications were recorded, and incidences of endoscopically detected thermal oesophageal lesions (EDEL) analysed. Recurrence rates after a mean follow-up of 25 ± 7 months and reconnection patterns in patients undergoing redo procedures were investigated. A total of 795 patients (67 ± 10 years; 58% male; 48% paroxysmal AF) underwent a first AF ablation with HPSD (211 in group AI 400/300 and 584 in group 450/350). Median procedure time was 82.9 ± 24.6 min with longer ablation times in patients with target AI 400/300 due to higher intraprocedural reconnection rates, increased box lesions, and additional right atrial isthmus ablations. EDEL rates among target AI 400/300 procedures were significantly lower (3% vs. 7%; P = 0.019). Correspondingly, AI 450/350 was the strongest independent predictor of post-ablation EDEL (OR 4.799, CI 1.427-16.138, P = 0.011). Twelve-month (76% vs. 76%; P = 0.892) and long-term ablation single procedure success (68% vs. 71%; log-rank P = 0.452) after a mean of 25 ± 7 months were comparable among both target AI groups; however, long-term success was significantly higher for paroxysmal AF compared to persistent AF (12 months: 80% vs. 72%; P = 0.010; end of follow-up: 76% vs. 65%; log-rank P = 0.001). One hundred three patients (16%) underwent a redo procedure during follow-up documented comparable pulmonary vein (PV) reconnection among groups. Multivariate predictors of AF recurrence were age, left atrium (LA) size, persistent AF, and extra-PV ablation targets. CONCLUSION: High-power short-duration AF ablation with target AI of 400 for non-posterior wall and 300 for posterior wall lesions resulted in comparable long-term results compared to higher AI (450/350) ablations with significantly lower risk for thermal oesophageal lesions. Older age, larger LA size, persistent AF, and extra-PV ablation targets were identified in a multivariate analysis as independent risk factors for recurrences of atrial arrhythmias.

Adverse Prognosis of Patients With Septal Substrate After VT Ablation Due to Electrical Storm.

BACKGROUND: Data about ventricular tachycardia (VT) ablation in patients with electrical storm (ES) is limited. OBJECTIVES: This study sought to compare the prognostic outcome of patients undergoing VT ablation after ES with and without a septal substrate. METHODS: In this large single-center study, consecutive patients presenting with ES and undergoing VT ablation from June 2018 to April 2021 were included. Patients with septal substrate were compared with patients without septal substrate regarding endpoints of cardiovascular mortality, VT recurrences, recurrences of the clinical VT, and rehospitalization rates. RESULTS: A total of 107 patients undergoing a first VT ablation because of electrical storm (ES) were included (age 65 ± 13 years, 86% male, 45% ischemic cardiomyopathy). Major complications occurred in 11% of all patients with increased postinterventional third-degree atrioventricular blocks among patients with septal substrate (9% vs 0%; P = 0.063). Partial ablation successes were similar (95% with a septal substrate vs 100% without a septal substrate; P = 0.251). Complete ablation success was achieved in 63% with a septal substrate and in 87% without a septal substrate (P = 0.004). After a median 22 months of follow-up, patients with septal substrate died significantly more often from cardiovascular causes (26% vs 7%; log-rank P = 0.018). In univariate analysis cardiovascular mortality for ES patients with septal substrate was 4.1-fold higher (HR: 4.192; CI: 1.194-14.719; P = 0.025). Independent predictors of adverse outcome in multivariable regression analysis were presence of septal substrate (HR: 5.723; P = 0.025) and increased age (HR: 1.104; P = 0.003). Recurrences of any ventricular arrhythmia (67% vs 56%; log rank P = 0.554) and rehospitalization rates (80% vs 66%; log rank P = 0.515) were similar between groups. Recurrences of clinical VT were similar (7% vs 2%; P = 0.252). CONCLUSIONS: Presence of a septal substrate is associated with adverse long-term cardiovascular mortality in patients admitted for VT ablation after ES. Despite decreased acute ablation successes in these patients, VT recurrence rates were similar to those without a septal substrate during follow-up.

Left atrial appendage thrombus formation, potential of resolution and association with prognosis in a large real-world cohort.

Comprehensive data on factors influencing left atrial appendage (LAA) thrombus formation, resolution and impact on survival are limited. In this single-center, retrospective study 7759 (2010-2015) patients with symptomatic ongoing atrial fibrillation (AF) on admission were screened for LAA thrombi. 450 patients had LAA thrombi. 481 patients without LAA thrombi were randomly selected as controls. We assessed clinical, echocardiographic, laboratory parameters and long-term survival of both groups. Patients with LAA thrombi compared to controls were older, had more strokes, higher CHA2DS2 -VASc scores, worse renal function, less controlled diabetes, advanced heart failure, lower LAA emptying velocities, higher levels of cardiac and inflammatory markers (all p < 0.001). 56.3% of followed-up patients (304) dissolved their LAA thrombi. Chances of thrombus resolution increased with rising LAA flow velocities (OR 1.061, p = 0.022), whereas advanced age (OR 0.950, p < 0.001) and presence of permanent AF (OR 0.354, p < 0.001) decreased chances of thrombus resolution. Presence of LAA thrombi was associated with a markedly reduced 10-year survival probability (31% versus 69%). LAA thrombus formation is promoted by advanced structural heart disease, inflammation, diabetes and impaired renal function. Younger age, non-permanent AF and higher LAA flow velocities were predictors of thrombus resolution. Thrombus formation was associated with poor prognosis.

Incidence of ablation-induced esophageal lesions and gastroparesis in patients undergoing ablation index guided high power short duration atrial fibrillation ablation.

INTRODUCTION: Aim of this study was to evaluate the incidence of ablation-induced endoscopically detected esophageal lesions (EDEL) and gastroparesis in patients undergoing high-power short-duration (HPSD) atrial fibrillation (AF) ablation using different target ablation index (AI) values. METHODS AND RESULTS: Consecutive patients undergoing AF ablation were included. Radiofrequency (RF) ablation was performed using HPSD ablation (50 W, target AI of 320 and 350 (group 1) and 380 (group 2) at posterior wall). Postablation endoscopy was performed in all patients. In total, 233 patients (66.8 ± 10 years; 52% male) were included consecutively (n = 137 patients in group 1 and n = 96 patients in group 2). Mean AI values und RF time at posterior wall was significantly higher and longer in group 2 compared to group 1 patients (413 ± 9 vs. 392 ± 19 AI, p < 0.01; 9.0 ± 0.8 s vs. 7.8 ± 0.7 s, p < 0.01). Esophageal endoscopy revealed esophageal lesions or gastroparesis in 43 of 233 patients (18.5%) in the total cohort (13.1% in group 1 and 26.0% in group 2; p = 0.02). Incidence of EDEL was 8.0% and 13.5% in group 1 and group 2, respectively. According to logistic analysis incidence of EDEL and/or gastroparesis was significantly lower in patients with a higher body mass index and higher in group 2 patients compared to group 1 patients. CONCLUSION: The incidence of EDEL or gastroparesis in patients undergoing HPSD AF ablation was 18.5% in the total cohort. The risk of EDEL and gastroparesis was associated with a higher AI target value of 380 compared to 320 and 350 at posterior wall and was reversely associated with body mass index.

Do Glucagonlike Peptide-1 Receptor Agonist and Sodium-glucose Co-transporter 2 Inhibitor Prescriptions in Germany Reflect Recommendations for Type 2 Diabetes with Cardiovascular Disease of the ADA/EASD Consensus Report?

OBJECTIVES: To analyze whether prescription use of GLP-1RA and SGLT2i in individuals with type 2 diabetes with cardiovascular disease (CVD) has increased after the ADA/EASD consensus guidelines (2018) in a German Real-World setting and which clinical characteristics are associated with prescription use of these drugs. METHODS: The Disease Analyzer database (IQVIA) comprises a representative panel of 1,373 general practitioners, diabetologists, and cardiologists throughout Germany (01/2015-12/2020: 12.6 million patients). Newly diagnosed type 2 diabetes (n=45,531) was identified by ICD-10 codes (E11). Matching (1:1) on practice specialty, sex, age, and year of diabetes diagnosis was performed for CVD. Logistic regression models were fitted to obtain adjusted odds ratios (OR) for characteristics associated with prescription use (median follow-up: 1.9 years). RESULTS: Overall, 35% of patients (n=16,006) were treated with glucose-lowering drugs during the first year after type 2 diabetes diagnosis (HbA1c≥7.0%: 80%). GLP-1RA (2.4%) and SGLT2i (8.5%) were rarely prescribed. After the consensus, use of GLP-1RA and SGLT2i increased, however, almost independently of pre-existing CVD (12/2019-11/2020 vs. 12/2017-11/2018: yes, no): GLP-1RA: from 5.7 to 9.2%, 5.2 to 7.6%; SGLT2i: from 13.9 to 20.4%, 12.1 to 16.6%. Among cardiovascular risk factors, the largest OR for GLP-1RA was for obesity (4.5; 95%CI: 3.2-6.3). CVD was moderately related with SGLT2i (1.45; 1.32-1.60) and GLP-1RA (1.35; 1.08-1.69) prescriptions. A weak association was observed between SGLT2i and heart failure (1.18; 95%CI: 1.05-1.32). CONCLUSION: National prescription use of GLP-1RA and SGLT2i did not come close to the recommendation in subjects with CVD issued by the 2018 ADA/EASD consensus.

Antithrombotic Treatment and Its Association with Outcome in a Multicenter Cohort of Transcatheter Edge-to-Edge Mitral Valve Repair Patients.

Transcatheter edge-to-edge mitral valve repair (TEER) has become established as a safe and efficacious therapy for severe mitral regurgitation (MR) in high-risk patients. Despite its widespread use, postprocedural antithrombotic therapy (ATT) still to date is based on local expertise rather than evidence. In a multicenter, observational cohort study, 646 consecutive patients undergoing TEER were enrolled; 609 patients were successfully treated and antithrombotic therapy analyzed; 449 patients (73.7%) were previously treated with oral anticoagulants (OAC) due to the high prevalence of atrial fibrillation (459/609, 75.4%). Postprocedural ATT in patients previously treated with OAC consisted of no additional, additional single (SAPT) or dual antiplatelet therapy (DAPT) in 146/449 (33.6%), 248/449 (55.2%) and 55/449 (12.2%), respectively. There were 234/449 (52.1%) patients treated with vitamin-k antagonists (VKA) and 215/449 (47.9%) with nonvitamin-k antagonist oral anticoagulants (NOAC). One hundred sixty patients (26.3%) had no prior indication for OAC and were predominantly treated with DAPT (132/160, 82.5%). Use of SAPT (17/160, 10.6%) and no APT (11/160, 6.9%) was marginal. No statistically significant differences in terms of in-hospital mortality or the rate of major adverse cardiac and cerebrovascular events (MACCE) between the different antithrombotic therapy regimens were observed. Multiple Cox regression analysis showed a statistically significant decreased risk for all-cause mortality after a median follow-up of 419 days for OAC monotherapy (HR 0.6, 95%-CI 0.5-0.9, p = 0.04). This study provides evidence for a more favorable long-term outcome of OAC monotherapy in patients with an indication for OAC and reiterates the urgent need for randomized controlled trials on the optimal antithrombotic treatment of TEER patients.

Radiofrequency ablation of atrial fibrillation-50 W or 90 W?

BACKGROUND: This study sought to evaluate the short and midterm efficacy and safety of the novel very high power very short duration (vHPvSD) 90 W approach compared to HPSD 50 W for atrial fibrillation (AF) ablation as well as reconnection patterns of 90 W ablations. METHODS AND RESULTS: Consecutive patients undergoing first AF ablation with vHPvSD (90 W; predefined ablation time of 3 s for posterior wall ablation and 4 s for anterior wall ablation) were compared to patients using HPSD (50 W; ablation index-guided; AI 350 for posterior wall ablation, AI 450 for anterior wall ablation) retrospectively. A total of 84 patients (67.1 ± 9.8 years; 58% male; 47% paroxysmal AF) were included (42 with 90 W, 42 with 50 W) out of a propensity score-matched cohort. 90 W ablations revealed shorter ablation times (10.5 ± 6.7 min vs. 17.4 ± 9.9 min; p = .001). No major complication occurred. 90 W ablations revealed lower first pass PVI rates (40% vs. 62%; p = .049) and higher AF recurrences during blanking period (38% vs. 12%; p = .007). After 12 months, both ablation approaches revealed comparable midterm outcomes (62% vs. 70%; log-rank p = .452). In a multivariable Cox regression model, persistent AF (hazard ratio [HR]: 1.442, 95% confidence interval [CI]: 1.035-2.010, p = .031) and increased procedural duration (HR: 1.011, 95% CI: 1.005-1.017, p = .001) were identified as independent predictors of AF recurrence during follow-up. CONCLUSIONS: AF ablation using 90 W vHPvSD reveals a similar safety profile compared to 50 W ablation with shorter ablation times. However, vHPvSD ablation was associated with lower rates of first-pass isolations and increased AF recurrences during the blanking period. After 12 months, 90 W revealed comparable efficacy results to 50 W ablations in a nonrandomized, propensity-matched comparison.

Efficacy and safety of high-power short duration atrial fibrillation ablation in elderly patients.

INTRODUCTION: Data about atrial fibrillation (AF) ablation using high-power short duration (HPSD) radiofrequency ablation in the elderly population is still scarce. The aim of our study was to investigate the efficacy and safety of HPSD ablation in patients over 75 years compared to younger patients. METHODS: Consecutive patients older than 75 years with paroxysmal or persistent AF undergoing a first-time AF ablation using 50 W HPSD ablation approach were analyzed in this retrospective observational analysis and compared to a control group <75 years. Short-term endpoints included intraprocedural reconnection of at least one pulmonary vein (PV) and intrahospital and AF recurrence during 3 months blanking period, as well as a long-term endpoint of freedom from atrial arrhythmias of antiarrhythmic drugs after 12 months. RESULTS: A total of 540 patients underwent a first AF ablation with HPSD (66 ± 10 years; 58% male; 47% paroxysmal AF). Mean age was 78 ± 2.4 and 63 ± 6.3 years (p < .001), respectively. Elderly patients were significantly more often women (p < .001). The procedure, fluoroscopy, and ablation were comparable. Elderly patients revealed significantly more often extra-PV low-voltage areas requiring additional left atrial ablations (p < .001). Overall complication rates were low; however, elderly patients revealed higher major complication rates mainly due to unmasking sick sinus syndrome (p = .003). Freedom from arrhythmia recurrences was comparable (68% vs. 76%, log-rank p = .087). Only in the subgroup of paroxysmal AF, AF recurrences were more common after 12 months (69% vs. 82%; log-rank p = .040; hazard ratio: 1.462, p = .044) in the elderly patients. In multivariable Cox regression analysis of the whole cohort persistent AF, female gender, diabetes mellitus and presence of left atrium low-voltage areas, but not age >75 years were associated with AF recurrences. CONCLUSION: HPSD AF ablation of patients >75 years in experienced centers is safe and effective. Therefore, age alone should not be the reason to withhold AF ablation from vital elderly patients due to only a slightly worse outcome and safety profile. In paroxysmal AF, elderly patients have more recurrences compared to the younger control group.

[CME: Plantar fasciitis]. / CME: Plantarfasziitis.

CME: Plantar fasciitis Abstract. Plantar fasciitis is a common pathology in general practice. There are diverse treatment options described in the literature, but no simple treatment algorithm for general practice has been published yet. In this article, we present an evidence-based and simple treatment algorithm for use in busy general practices. Important to note, adequate patient education is crucial since the patient himself has a great influence on the healing process. In most cases, conservative treatment is promising and remission can be achieved within weeks or a few months.

Safety aspects of very high power very short duration atrial fibrillation ablation using a modified radiofrequency RF-generator: Single-center experience.

INTRODUCTION: High power short duration (HPSD) ablation proved to be an effective and safe ablation technique for atrial fibrillation (AF). In former case series, a significant amount of postablation coagulation at the catheter tip as well as silent cerebral lesions (SCL) in postprocedural cerebral magnetic resonance (cMRI) have been identified in patients undergoing de-novo AF ablations with very high power 90 W short duration (vHPvSD) ablations using the QDot ablation catheter in combination with a novel RF generator (nGEN, Biosense Webster). Therefore, the RF generator software has been recently modified. METHODS AND RESULTS: Consecutive patients undergoing a first AF ablation including pulmonary vein isolation (PVI) with vHPvSD (90 W, with a predefined ablation time of 3 s at posterior left atrium (LA) wall sites and 4 s at other ablation sites) using the QDOT Micro ablation catheter (Biosense Webster) in conjunction with the technically modified nGEN RF generator (software V1c; Biosense Webster) were included. Procedural characteristics including first-pass isolation per pulmonary vein (PV) pair and early reconnection location within the 30-min waiting period were recorded. In all patients postablation endoscopy to document any thermal esophageal injury (EDEL) and in eligible patients a cMRI to detect silent cerebral events (SCEs)/lesions were performed. All acute procedure-related complications were recorded during the time until hospital discharge. Furthermore, short-term and midterm success after 3 and 6-12 months of follow-up was investigated. In total, 34 consecutive patients (67 ± 9 years; 62% male; 68% paroxysmal AF) were included. First-pass isolation of all PVs was achieved in 6/34 (18%) patients. First-pass isolation was seen in 37/68 (54%) of PV pairs. Early reconnection occurred in 11 (32%) patients (including reconnections at posterior LA wall sites n = 6 and at nonposterior sites n = 5). No patient had an EDEL (0%). In 6/23 (26%) patients undergoing postablation cerebral MRI SCEs were identified. In six patients, coagulation on the catheter tip was detected at the end of the procedure. No further peri- or postprocedural complications were detected. Early AF recurrence before discharge was seen in 1/34 (3%) of the patients included in this study. Within 3 months 10/34 (29%) revealed AF recurrence during blanking period. After a mean follow-up of 7 months, 31/34 (88%) patients revealed sinus rhythm. CONCLUSION: AF ablation using 90 W vHPvSD with a specialized ablation catheter in conjunction with a recently modified RF generator was associated with no EDEL in the whole study cohort and 26% SCEs in a subgroup of patients undergoing acute postablation cerebral MRI. Accordingly, to our previously published results, a relevant number of catheter tip coagulations was identified in this patient cohort even after modifications of the RF generator. The vHPvSD ablation technique using the present and the previous generator seems to be associated with a very low rate of esophageal injury. However, the recently revised generator software also produced a relevant number of catheter tip coagulum formation and SCEs.

Functional and hemodynamic result with the PASCAL Ace percutaneous mitral valve repair: A single-center experience.

OBJECTIVES: The PASCAL device is a transcatheter edge-to-edge repair system (TEER) for treatment of mitral regurgitation (MR). The PASCAL Ace as a newer version of the PASCAL device consists of a thinner profile without a spacer. The aim of the study was to examine the functional and hemodynamic outcome after TEER with the PASCAL Ace device in a real-world cohort. METHODS: Between September 2020 and August 2021, all consecutive patients with MR 3+/4+ treated percutaneously with PASCAL Ace were included in this study. Primary endpoints included successful device implantation, device success, improvement of exercise capacity, quality of life, and a composite of all-cause mortality, non-fatal stroke, myocardial infarction, new need for renal replacement therapy or severe bleeding at 30 days and 5 month. RESULTS: 49/66 patients had a functional etiology. Overall success rate was 98.5%. At follow-up, 84.7% of the patients had MR grade ≤ 1. TEER was associated with an improvement of LV ejection fraction (45% to 53%, p = 0.048). 86.5% were in NYHA class I or II. 6-minute-walking distance improved by 79m (p = 0.009). Kansas City Cardiomyopathy Questionnaire (KCCQ) improved by 19 points (p = 0.012). NT-proBNP levels decreased from 4832 to 2137 pg/dl (p = 0.003). Mean pulmonary capillary wedge pressures improved from 21 to 15mmHg (p = 0.001). At 5 month, a total of 3 patients died, none of cardiovascular cause. CONCLUSION: PASCAL Ace is safe and effective in treating MR, resulting in a sustained MR reduction, a reverse cardiac remodelling, improvement of exercise capacity, quality of life, NT-proBNP levels and hemodynamics at follow-up.