Incidence, Predictors, and Outcomes of Paravalvular Regurgitation after TAVR in Sievers Type-1 Bicuspid Aortic Valves.

BACKGROUND: Transcatheter aortic valve replacement (TAVR) in patients with bicuspid aortic valve (BAV) stenosis is technically challenging and is burdened by an increased risk of paravalvular regurgitation (PVR). OBJECTIVES: To identify the incidence, predictors, and clinical outcomes of PVR following TAVR in Sievers type 1 BAV stenosis. METHODS: Consecutive patients with severe Sievers type 1 BAV stenosis undergoing TAVR with current generation transcatheter heart valves (THVs) in 24 international centres were enrolled. PVR was graded as none/trace, mild, moderate, and severe according to echocardiographic criteria. The endpoint of major adverse events (MAE), defined as a composite of all-cause death, stroke, or hospitalization for heart failure, was assessed at the last available follow-up. RESULTS: A total of 946 patients were enrolled. PVR occurred in 423 patients (44.7%): mild, moderate, and severe in 387 (40.9%), 32 (3.4%), and 4 (0.4%) patients, respectively. Independent predictors of moderate or severe PVR were larger virtual raphe ring (VRR) perimeter (ORadj 1.07, 95% CI 1.02-1.13), severe annular or left ventricular outflow tract (LVOT) calcification (ORadj 5.21, 95% CI 1.45-18.77), self-expanding valve (ORadj 9.01, 95% CI 2.09-38.86), and intentional supra-annular THV positioning (ORadj 3.31, 95% CI 1.04-10.54). At a median follow-up of 1.3 [IQR 0.5-2.4] years, moderate or severe PVR was associated with an increased risk of MAE (HRadj 2.52, 95% CI 1.24-5.09). CONCLUSIONS: After TAVR with current-generation THVs in Sievers type 1 BAV stenosis, moderate or severe PVR occurred in about 4% of cases and was associated with an increased risk of MAE during follow-up.

Third-generation subcutaneous implantable cardioverter defibrillator and intermuscular two-incision implantation technique in patients with Arrhythmogenic cardiomyopathy: 3-year follow-up.

BACKGROUND: Long-term data on the potential advantages of combining the third-generation subcutaneous implantable cardioverter defibrillator (S-ICD) with modern software upgrade including the "SMART Pass", modern programming strategies and the intermuscular (IM) two-incision implantation technique in arrhythmogenic cardiomyopathy (ACM) with different phenotypic variants are lacking. In this study we evaluated the long-term outcome of patients with ACM who underwent third-generation S-ICD (Emblem, Boston Scientific) and IM two-incision technique. METHODS: The study population included 23 consecutive patients [70% male, median age 31 (24-46) years] diagnosed with ACM with different phenotypic variants who received third-generation S-ICD implantation with the IM two-incision technique. RESULTS: During a median follow-up of 45.5 months [16-65], 4 patients (17.4%) received a at least one inappropriate shock (IS), with median annual event rate of 4.5%. Extra-cardiac oversensing (myopotential) during effort represented the only cause of IS. No IS due to T-wave oversensing (TWOS) were recorded. Only one patient (4.3%) experienced device-related complication consisting of premature cell battery depletion requiring device replacement. No device explantation because of need for anti-tachycardia pacing or ineffective therapy occurred. There was no significant difference between patients who did and did not experienced IS with regard to baseline clinical, ECG and technical characteristics. Five patients (21.7%) received appropriate shocks on ventricular arrythmias. CONCLUSIONS: According to our findings, although the third-generation S-ICD implanted with the IM two-incision technique appears to be associated with a low risk of complications and IS due to cardiac oversensing, the risk of IS due to myopotential mainly during effort should be considered.

Intermuscular two-incision technique for implantation of the subcutaneous implantable cardioverter defibrillator: a 3-year follow-up.

PURPOSE: The aim of the present study was to evaluate the outcome of patients underwent subcutaneous implantable cardioverter defibrillator (S-ICD) implantation with the intermuscular (IM) two-incision technique during 3-year follow-up. METHODS: the study population consisted of 105 consecutive patients (79 male; median 50 [13-77] years) underwent S-ICD implantation with the IM two-incision technique. The composite primary end point of the study consisted of device-related complications and inappropriate shocks (IAS). Secondary end points included the individual components of the primary end point, death from any cause, appropriate therapy, major adverse cardiac events, hospitalization for heart failure, and heart transplantation. RESULTS: According to the PRAETORIAN score, the risk of conversion failure was classified as low in 99 patients (94.3%), intermediate in 6 (5.7%).Ventricular fibrillation was successfully converted at ≤65 J in 97.4% of patients. During a median follow-up of 39 (16-53) months, 10 patients (9.5%) experienced device-related complications, and 9 (8.5%) patients reported IAS. Lead-associated complications were the most common (5 patients, 4.7%), including 2 cases of lead failure (1.9%). Pocket complications were reported in 2 patients (1.9%). Extra-cardiac oversensing (3.8%) represented the leading cause of IAS. No T-wave oversensing episodes were recorded. Twelve patients (11.4%) experienced appropriate shocks. Eight patients (7.6%) died during follow-up. IAS or device-related complications did not impact on mortality. CONCLUSIONS: The overall device-related complications and IAS rates over 3 years of follow-up were 9.5% and 8.5%, respectively. According to our findings, the IM two-incision technique allows for optimal positioning of the device achieving a low PRAETORIAN score with a high conversion rate. IM two-incision technique allows low incidence of pocket complications, shifting the type of complications towards lead-related complications, which represent the most common complications. The IM two-incision technique would not seem to impact the occurrence of IAS. Management of complications are safe without impact on the outcome.

Multiparametric identification of subclinical atrial fibrillation after an embolic stroke of undetermined source.

BACKGROUND: Subclinical atrial fibrillation (SCAF) may represent a cause of embolic stroke of undetermined source (ESUS) and its detection has important implications for secondary prevention with anticoagulation. Indications to implantable cardiac monitors (ICM) include SCAF detection. The aims of this study were to (1) evaluate the frequency of ICM-detected SCAF; (2) determine predictors of SCAF; and (3) identify patients who would benefit most from ICM implantation. METHODS: Between February 2017 and November 2020, all consecutive patients referred for ICM implantation after a diagnosis of ESUS and without previous history of atrial fibrillation or atrial flutter were included in this study. SCAF was diagnosed if the ICM electrogram demonstrated an episode of irregularly irregular rhythm without distinct P waves lasting > 2 min. RESULTS: We enrolled 109 patients (age 66, SD = 13 years; 36% females). During a median follow-up of 19.2 (IQR 11.0-27.5) months, SCAF episodes were detected in 36 (33%) patients. Only abnormal P wave terminal force in lead V1, left atrial end-systolic indexed volume > 34 ml/m2, and BMI > 25 kg/m2 were independently associated with an increased risk of SCAF (HR 2.44, 95% CI 1.14-5.21, p = 0.021; HR 2.39, 95% CI 1.11-5.13, p = 0.026; and HR 2.64, 95% CI 1.06-6.49, p = 0.036 respectively). The ROC curve showed that the presence of all three parameters had the best accuracy (74%) to predict SCAF detection (sensitivity 39%, specificity 91%). CONCLUSION: A multiparametric evaluation has the best accuracy to predict SCAF in ESUS patients and may help identifying those who would benefit most from ICM.

Coronary Flow Evaluation in Heart Transplant Patients Compared to Healthy Controls Documents the Superiority of Coronary Flow Velocity Reserve Companion as Diagnostic and Prognostic Tool.

Background: Distinct contributions by functional or structural alterations of coronary microcirculation in heart transplantation (HT) and their prognostic role have not been fully elucidated. We aimed to identify the mechanisms of coronary microvascular dysfunction (CMD) in HT and their prognostic implications. Methods: 134 patients, surviving at least 5 years after HT, without evidence of angiographic vasculopathy or symptoms/signs of rejection were included. 50 healthy volunteers served as controls. All underwent the assessment of rest and hyperemic coronary diastolic peak flow velocity (DPVr and DPVh) and coronary flow velocity reserve (CFVR) and its inherent companion that is based on the adjusted quadratic mean: CCFVR = √{(DPVr)2 + (DPVh)2}. Additionally, basal and hyperemic coronary microvascular resistance (BMR and HMR) were estimated. Results: Based on CFVR and DPVh, HT patients can be assigned to four endotypes: endotype 1, discordant with preserved CFVR (3.1 ± 0.4); endotype 2, concordant with preserved CFVR (3.4 ± 0.5); endotype 3, concordant with impaired CFVR (1.8 ± 0.3) and endotype 4, discordant with impaired CFVR (2.0 ± 0.2). Intriguingly, endotype 1 showed lower DPVr (p < 0.0001) and lower DPVh (p < 0.0001) than controls with lower CFVR (p < 0.0001) and lower CCFVR (p < 0.0001) than controls. Moreover, both BMR and HMR were higher in endotype 1 than in controls (p = 0.001 and p < 0.0001, respectively), suggesting structural microvascular remodeling. Conversely, endotype 2 was comparable to controls. A 13/32 (41%) patients in endotype 1 died in a follow up of 28 years and mortality rate was comparable to endotype 3 (14/31, 45%). However, CCFVR was < 80 cm/s in all 13 deaths of endotype 1 (characterized by preserved CFVR). At multivariable analysis, CMD, DPVh < 75 cm/s and CCFVR < 80 cm/s were independent predictors of mortality. The inclusion of CCFVR < 80 cm/s to models with clinical indicators of mortality better predicted survival, compared to only adding CMD or DPVh < 75 cm/s (p < 0.0001 and p = 0.03, respectively). Conclusion: A normal CFVR could hide detection of microvasculopathy with high flow resistance and low flow velocities at rest. This microvasculopathy seems to be secondary to factors unrelated to HT (less rejections and more often diabetes). The combined use of CFVR and CCFVR provides more complete clinical and prognostic information on coronary microvasculopathy in HT.

Subcutaneous implantable cardioverter defibrillator after transvenous lead extraction: safety, efficacy and outcome.

BACKGROUND: Subcutaneous implantable cardioverter defibrillator (S-ICD) is a suitable alternative for transvenous ICD (TV-ICD) patients who have undergone transvenous lead extraction (TLE). Limited data are available on the outcome of S-ICD patients implanted after TLE. We assessed the safety, efficacy, and outcome of S-ICD implantation after TLE of TV-ICD. METHODS: The study population consisted of 36 consecutive patients with a median age of 52 (44-66) years who underwent S-ICD implantation after TLE of TV-ICD. RESULTS: Indications for TLE were infection (63.9%) and lead malfunction (36.1%). During a median follow-up of 31 months, 3 patients (8.3%) experienced appropriate therapy and 7 patients (19.4%) experienced complications including inappropriate therapy (n = 4; 11.1%), isolated pocket erosion (n = 2; 5.5%), and ineffective therapy (n = 1; 2.8%). No lead/hardware dysfunction was reported. Premature device explantation occurred in 4 patients (11%). Eight patients (22.2%) died during follow-up, six of them (75%) because of refractory heart failure (HF). There were no S-ICD-related deaths. Predictors of mortality included NYHA class ≥ 2 (HR 5.05; 95% CI 1.00-26.38; p = 0.04), hypertension (HR 22.72; 95% CI 1.05-26.31; p = 0.02), diabetes (HR 10.64; 95% CI 2.05-55.60; p = 0.001) and ischemic heart disease (HR 5.92; 95% CI 1.17-30.30; p = 0.01). CONCLUSION: Our study provides evidences on the use of S-ICD as an alternative after TV-ICD explantation for both infection and lead failure. Mortality of S-ICD patients who underwent TV-ICD explantation does not appear to be correlated with the presence of a prior infection, S-ICD therapy (appropriate or inappropriate), or S-ICD complications but rather to worsening of HF or other comorbidities.

Safety and Feasibility of Transcatheter Aortic Valve Replacement in COVID-19 Patients: A Case Series.

In 2020, the coronavirus disease 2019 (COVID-19) pandemic has led to a decrease in interventional treatment for structural heart disease worldwide. In this context, the management of patients with symptomatic severe aortic stenosis (AS) or bioprosthetic valve dysfunction (BVD) represents a clinical challenge, as a delay in aortic valve replacement procedures may increase short-term morbidity and mortality. We report four cases of TAVR performed in patients with Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infection. All of them were discharged in good clinical conditions and no adverse events were reported at 30 days follow-up. Our experience suggests that in selected patients with mild SARS-CoV-2 infection and symptomatic native AS or BVD, TAVR has a favorable short-term outcome.