Recall devices: Defects at initial visit and during remote monitoring supported follow-up.

BACKGROUND: In March 2021, Biotronik informed about the risk of premature battery depletion in a group of implantable cardioverter-defibrillators. Following the manufacturers' recommendation, our center executed a recall and introduced remote monitoring (RM) in patients with susceptible devices. This study reports the rate of premature battery depletion in our center and events found in RM-supported follow-up. METHODS: Single-center observational study. RESULTS: Out of the 206 susceptible implanted devices, 125 patients appeared for the visit and RM was introduced in 107 (83%) patients. Until the visit, three (2.4%) devices required replacement due to battery depletion, and a further three (2.4%) devices had unexpected battery depletion during follow-up. CONCLUSIONS: The recalled devices had a higher rate of battery exhaustion than expected, while other device or lead defects were less common.

Complications of cardiac resynchronization therapy implantation: De novo implants versus upgrades.

BACKGROUND: Cardiac resynchronization therapy (CRT) is a well-established treatment of patients with advanced heart failure and electrical dyssynchrony. Implantation of those devices is in some cases associated with intervention on a formerly implanted system. The aim of this analysis was to compare the rate and type of complications of de novo implants and upgrades to CRT-D. METHODS: Retrospective data were collected from medical records, including 326 patients treated with CRT-D between 2015 and 2020. The following data were analyzed: procedure data including complications, demographics, co-morbidities, pharmacotherapy, and laboratory tests. The primary endpoint of the study was all-cause mortality. RESULTS: A total of 326 procedure were included, of which 53% (n = 172) were de novo implants and 47% (n = 154) were upgrades. The groups did not differ in the incidence of complications: in the de novo group: 25.5% (n = 44); in the upgrade group: 30.5% (n = 47), p = 0.78. The incidence of complications was also similar in respect of the following: early (p = 0.98) and late (p = 0.45), infectious (p = 0.38) and non-infectious (p = 0.82), surgical (p = 0.38) and device or lead related (p = 0.6). The most common complication in the upgrade group was pocket hematoma (n = 9, 5.8%) and in the de novo group pneumothorax (n = 8, 4.7%). CONCLUSIONS: Upgrade procedures of are not associated with a higher percentage of complications than de novo implantations of CRT-D. Previously implanted cardiac implantable electronic device should not limit the implantation of CRT-Ds.

Follow-up and characteristics of recipients of cardiac resynchronization therapy with and without a defibrillator.

BACKGROUND: Cardiac resynchronization therapy defibrillator (CRT-D) and pacemaker (CRT-P) are treatment options for patients with advanced heart failure and electrical dyssynchrony. Current guidelines provide only factors favoring, not specific recommendations as to implant CRT-D or CRT-P. This analysis aimed to compare and contrast populations of CRT-D and CRT-P recipients. METHODS: Retrospective data were collected from medical records, including 231 patients treated with either CRT-D or CRT-P between 2015 and 2019. Following data were analyzed demographics, co-morbidities, pharmacotherapy, laboratory tests, and data related to the procedure of implantation. The primary endpoint of the study was all-cause mortality. RESULTS: A total of 231 patients were included (mean age [standard deviation, SD], 64.1 [12.3] years, 76% male), of these, 13.6% (n = 32) with CRT-P and 86.4% (n = 199) with CRT-D. Mean New York Heart Association (NYHA) class did not differ between the groups: 2.23 (0.9) in CRT-P and 2.35 (0.6) in CRT-D group (P = 0.42). Mean left ventricular ejection fraction was lower in patients eligible for CRT-D: 27.1% vs. 38% (P < 0.001). Patients were followed for a median (interquartile range [IQR]) of 29 (13-44) months and survival in the CRT-P group was 84%, in CRT-D - 82% (P = 0.74). Patients in the CRT-P group were older, and more often after atrioventricular node ablation. The CRT-P group had tendency towards higher Charlton Comorbidity Index, reaching a mean of 4.66 (1.5) points vs. 3.96 (1.5) points in CRT-D (P = 0.06). CONCLUSIONS: Populations with CRT-P and CRT-D differ in terms of comorbidities; however, they have similar survival. Further studies are required to identify a group of patients, who derive a benefit from adding a defibrillator.

Balloon Pulmonary Angioplasty in Technically Operable and Technically Inoperable Chronic Thromboembolic Pulmonary Hypertension.

BACKGROUND: In this study, we aimed to assess the efficacy and safety of balloon pulmonary angioplasty (BPA) in patients with technically inoperable distal-type chronic thromboembolic pulmonary hypertension (d-CTEPH) and technically operable proximal-type disease (p-CTEPH) by analyzing the results of BPA treatment in two collaborating CTEPH referral centers. METHODS AND RESULTS: We assessed hemodynamic results, functional efficacy, complication and survival rate after BPA treatment in 70 CTEPH patients (median age 64 years; (interquartile range (IQR): 52-73 years)), of whom 16 (median age 73 years; (QR 62-82 years)) were in the p-CTEPH subgroup. Altogether, 377 BPA procedures were performed, resulting in significant (p < 0.001) improvement in mean pulmonary artery pressure (mPAP 48.6 ± 10 vs. 31.3 ± 8.6 mmHg), pulmonary vascular resistance (694 ± 296 vs. 333 ± 162 dynes*s*cm-5), six-minute walk test (365 ± 142 vs. 433 ± 120 metres) and N-terminal pro B-type natriuretic peptide (1307 (510-3294) vs. 206 (83-531) pg/mL). The rate of improvement did not differ between the sub-groups. Lung injury episodes and severe hemoptysis were similarly infrequent in d-CTEPH and p-CTEPH (6.4% vs. 5%; p = 0.55 and 1.0% vs. 2.5; p = 0.24, respectively). There was no significant difference between the sub-groups regarding survival (p = 0.53 by log-rank test). CONCLUSION: BPA may be beneficial in patients with p-CTEPH who cannot undergo pulmonary endarterectomy (PEA). Larger long-term studies are needed to better define the efficacy, safety, and optimal BPA procedural standards in this population.

Right heart catheterization procedures in patients with suspicion of pulmonary hypertension - experiences of a tertiary center.

INTRODUCTION: Right heart catheterization (RHC) is an invasive procedure providing direct and accurate measurements of hemodynamics of the cardiovascular system. Acute pulmonary vasoreactivity testing (APVT) following basal RHC in some patients is an established tool evaluating the reversibility of hypertension in the pulmonary vasculature. AIM: We sought to assess the most common indications, vascular approaches and complications during RHC in a single high-volume center. MATERIAL AND METHODS: A total of 534 RHC procedures in 348 patients (64% male) were performed. The prospective registry was carried out for 28 months. Collected data included indications for RHC, vascular approaches, hemodynamic and clinical data, complications and response of pulmonary vessels in APVT. RESULTS: In 401 (75%) procedures pulmonary hypertension (mean pulmonary artery pressure (mPAP) ≥ 25 mm Hg) was confirmed. Left heart failure was the most common indication (55.8%), mainly ischemic (26%) or dilated cardiomyopathy (19.9%). Other indications included a suspicion of arterial (21.7%), or chronic thromboembolic pulmonary hypertension (14.6%). The right internal jugular vein approach was used in 89.1% of procedures. Acute pulmonary vasoreactivity testing was performed in 143 patients, and it was positive in 67 (46.9%) cases. Complications occurred in 21 (3.9%) procedures and included pulmonary edema (0.2%), pneumothorax (0.2%) and puncture of the artery followed by the insertion of a vascular sheath (0.4%), atrial arrhythmia (0.2%), superior vena cava dissection (0.2%), incidental artery puncture (1.1%) and local hematoma (2.2%). CONCLUSIONS: The most frequent indication for RHC was left heart failure, and the most common approach was the right internal jugular vein. RHC is safe procedure with a low rate of major complications.