Left atrial appendage closure with the watchman device reduces atrial fibrillation management costs.

AIMS: To report hospitalization costs of patients with non-valvular atrial fibrillation (AF) submitted to percutaneous left atrial appendage closure (LAAC) with the Watchman device. METHODS: Pre- and post-procedural hospitalization AF-related costs were calculated using the DRG system (diagnosis-related groups) and compared. RESULTS: Between 2012 and 2016, 677 non-valvular AF patients underwent LAAC. Median time from first cardiac hospitalization to LAAC was 5.9 years (IQR 1.6-9.1) and median follow-up after LAAC was 4.8 years (IQR 3.6-5.6). LAAC mortality was 1.3% and follow-up mortality 16.9%. Median pre-LAAC hospitalization cost was € 17,867 (IQR € 7512-35,08) and post-LAAC € 8772 (IQR € 1183-25,159) (p < 0.0001). Annualized cost pre-LAAC was 3773 € (IQR € 1644-8,493) and post-LAAC 2,001 € (IQR € 260-6913) (p < 0.0001). Follow-up survivors had significantly lower post-LAAC costs (p < 0.0001) and after a survival cut-off time of 4.6 years LAAC procedural and post-procedural hospitalization costs achieved parity with pre-LACC costs (AUC 0.64; p = 0.02). CHA2DS2-VASc score (B = 0.04; p = 0.02; 95% CI 0.006-0.08), and HAS-BLED score (B = 0.08; p = 0.004; 95% CI 0.02-0.14) were independent determinants for annualized hospitalization costs post-LAAC. At Cox-regression analysis the DRG mean clinical complexity level (CCL) was the only independent determinant for follow-up mortality (OR = 2.2; p < 0.0001; 95% CI 1.6-2.8) with a cut-off value of 2.25 to predict follow-up mortality (AUC 0.72; p < 0.0001; Spec. 70%; Sens. 70%). CONCLUSION: Hospitalization costs pre-LAAC are consistent, and after LAAC, they are significantly reduced. Costs seem related to the patient's risk profile at the time of the procedure. With the increase in post-LAAC survival time, the procedure becomes economically more profitable.

Actual management costs of patients with non-valvular atrial fibrillation treated with percutaneous left atrial appendage closure or oral anticoagulation.

AIMS: Comparing actual management costs in patients with non-valvular atrial fibrillation (AF) treated with percutaneous left atrial appendage closure (LAAC) or OAC only. METHODS AND RESULTS: Patients undergoing percutaneous LAAC and AF patients treated with OAC only were matched for gender, age, and diagnosis related groups (DRG) clinical complexity level (CCL). Costs for cardiovascular outpatient clinic visits and hospitalizations were derived from the actual reimbursement records. Between 1/2012 and 12/2016, 8478 patients were referred: 7801 (92%) managed with OAC and 677 (8%) with percutaneous LAAC. Matching resulted in 558 patients (279 per group) for final analysis. Age was 74.9 ± 7.5 years, 244 were female (43.7%), and DRG CCL was 1.8 ± 1.1. Annualized management cost before percutaneous LAAC was € 3110 (IQR: € 1281-8127). After 4.5 ± 1.4 years follow-up, annualized management cost was € 1297 (IQR: € 607-2735) in OAC patients and € 1013 (IQR: € 0-4770) in patients after percutaneous LAAC (p = 0.003). Percutaneous LAAC was the strongest independent determinant to reduce follow-up costs (B = -0.8; CI: -1.09 ̶̶̶̶̶ -0.6; p < 0.0001). Estimated 3-year survival was 92% in percutaneous LAAC and 90% in OAC patients (p = 0.7). CONCLUSION: Percutaneous LAAC significantly reduces management costs. Management costs are significantly higher for patients treated with only OAC compared to patients after percutaneous LAAC. In spite of their complex comorbid profile, percutaneous LAAC patients show a follow-up survival rate similar to patients solely treated with OAC. Future studies are necessary to investigate the potential net economic and clinical benefit of percutaneous LAAC in patients treated with OAC only.

Routine Transesophageal Echocardiography in Atrial Fibrillation Before Electrical Cardioversion to Detect Left Atrial Thrombosis and Echocontrast.

BACKGROUND: Transesophageal echocardiography (TEE) before electrical cardioversion (ECV) in atrial fibrillation (AF) is not routinely performed in anticoagulated patients. METHODS: Starting from TEE findings of anticoagulated and non-anticoagulated patients referred for ECV, we investigated the rate of spontaneous echo-contrast (SEC) and left atrial thrombus (LAT) and identified their independent predictors. RESULTS: A total of 403 patients were included: 262 (65%) had no anticoagulation, 47 (11.7%) were onnovel oral anticoagulant (rivaroxaban), 74 (18.4%) on warfarin INR>2, and 20 (5.0%) on warfarin INR<2.In 41 (10.1%) there was LAT and in 154 (38.2%) SEC. Patients with LAT had a significantly lower left ventricular ejection fraction (LVEF%) (p=0.001). Patients with SEC were significantly older (p=0.04), had lower LVEF% (p<0.0001),higher CHADSVASC score (p<0.0001), and higher rate of coronary artery disease (CAD) (p=0.03). In 56.8% of warfarin patients (INR>2) there was SEC (p=0.002). At multivariate analysis therapeutic anticoagulation with warfarin (p=0.003; OR:2.2; CI: 1.3-3.7),CHADSVASC score (p<0.0001; OR=1.2; CI: 1.1-1.4), and LVEF% (p<0.0001; OR:0.95; CI: 0.93-0.97; inverse relationship) were SEC predictors. A 3.5 CHADSVASC score cut-off was predictor of SEC (AUC: 0.7; p<0.0001). LVEF% was the only predictor of LAT (p=0.02; OR=0.96; CI: 0.93-0.99; inverse relationship). CONCLUSIONS: Echocardiography before ECV identifies clear LAT/SEC in more than a third of AF patients, independently by their anticoagulation regimen. LAT/SEC rates increasewith decrement of LVEF%. Increment of CHADSVASC score increases SEC risk. In anticoagulated patients SEC rate remains higher than expected. Therapeutic anticoagulation with Warfarin appears positively and independently correlated to SEC occurrence.

Determinants of inappropriate implantable cardioverter-defibrillator shocks: the German Device Registry perspective.

BACKGROUND: In the present study, we have focused upon rates and clinical determinants of inappropriate shock (IS) after implantable cardioverter-defibrillator (ICD). METHODS: Data were collected prospectively in the German Device II Registry. RESULTS: A total of 783 patients were included. Three sub-groups were identified: non-shock (NS) included 725 patients (92.6%), IS 24 (3.1%), and appropriate shock (AS) 34 (4.3%). IS patients were younger (AS 68 (58-77); IS 59 (51-68); NS 66 (56-75) years; p = 0.03), had been mainly referred for primary prophylaxis (AS 42.4%; IS 70.8%; NS 67.3%; p = 0.01), had a higher resting heart rate (AS 70 (63-80); IS 80 (71-98); NS 70 (60-81) BPM; p = 0.003), had more often atrial fibrillation (AF) (AS 14.7%; IS 45.8%; NS 18.8%; p = 0.006), and shorter QRS duration (AS 100 (90-120); IS 95 (90-100); NS 120 (98-150) msec.; p = 0.001). VVI-ICD was more common in IS (AS 64.7%; IS 83.3%; NS 49.8%; p = 0.002). At a follow-up of 18.2 months (75% IQR 13.6-22.4), no deaths were observed in the IS group, one (2.9%) in the AS, and 36 (4.9%) in the NS (p = 0.9). At logistic regression, VVI-ICD implantation was the strongest IS independent determinant (OR 5.0; 95% CI 1.6-15.9; p = 0.004) together with age < 70 years (OR 4.6; CI 1.4-14.7; p = 0.009), AF at time of ICD implantation (OR 3.5; CI 1.3-9.1; p = 0.01), and resting heart rate > 70/min (OR 2.8; CI 1.0-7.3; p = 0.03). CONCLUSION: In a contemporary setting, some specific conditions such as VVI-ICD, younger age, and faster resting heart rates remain important IS determinants after ICD implantation.

Pacing-induced cardiomyopathy in chronic right ventricular apical pacing: a midterm follow-up study.

BACKGROUND: Data concerning the effect of chronic right ventricular pacing in patients with normal left ventricular ejection fraction (LVEF%) are contradictory. The aim of this study is to evaluate the prevalence of pacing-induced cardiomyopathy (PICM) at midterm follow-up after permanent pacemaker implantation (PPM). METHODS: A series of 170 patients were submitted to PPM within our facility. Inclusion criteria were the absence of structural heart disease and a preserved LVEF% (> 45%) at the time of PPM. A midterm clinical and echocardiographic follow-up was performed, and data were collected and analyzed retrospectively. PICM was defined as follow-up LVEF ≤ 45%, dyskinesia during RV pacing, and the absence of other known causes of cardiomyopathy. RESULTS: At a median echocardiographic follow-up of 24.5 months (IQR 10.0-43.0 months), the overall mean LVEF% decreased from a preimplantation value of 66.7% (± 8.6%) to 63.2% (± 10.6%) (p < 0.0001). PICM occurred in 11 patients (6.5%). Patients developing PICM had a significantly lower preimplantation LVEF% (58.4 ± 8.0% vs. 67.3 ± 8.4%; p = 0.005), a trend for higher right ventricular pacing time rate (0.7 ± 0.3 vs. 0.5 ± 0.4; p = 0.1), a significantly lower rate of PPM indication for sick sinus syndrome (SSS) (18.2% vs. 61.0%; p = 0.009), and significantly higher rate of second-grade cardiac conduction block (36.4% vs. 11.3%; p = 0.03). At multivariate logistic regression, only preimplantation LVEF% (OR = 0.88; CI 0.80-0.96; p = 0.006) and the presence of SSS (OR = 0.1; CI 0.03-0.9; p = 0.04) were independently related (inverse relationship) to follow-up PICM. CONCLUSIONS: In this selected PPM patient cohort with preserved LVEF%, the rate of PICM at midterm follow-up is relatively low, but its occurrence seems to be related to baseline LVEF% and PPM indication category.

Transaortic Transcatheter Aortic Valve Implantation: Learning Curve, Perioperative, and Midterm Follow-Up Results of a Single Center.

BACKGROUND: We present our initial institutional experience with transaortic (TAo) transcatheter aortic valve implantation (TAVI) using a self-expanding aortic bioprosthesis. METHODS: A total of 106 patients underwent TAo TAVI with Medtronic CoreValve through a small partial upper sternotomy. We focus our analysis on the overall perioperative results, procedural learning curve (first 30 patients), and midterm follow-up outcomes. RESULTS: VARC-2 device success was achieved in 95 patients (89%), and there were no intraoperative deaths. Nine patients (8.4%) required a second valve and conversion to standard surgery was required in 2 patients (1.8%). The final aortic insufficiency was grade 0 in 65 patients (62%) and grade 1 in 39 (37%). Although patients treated in the TAo TAVI learning phase required a significantly longer radiation time and contrast agent use, device success (93.4% versus 88.2%, P = .7) and prostheses hemodynamics were similar. All-cause mortality at 30 days was 12% (13/106). At a median follow-up of 392 days (IQR: 216-494 days) estimated overall 1-year survival was 72%. No significant differences were reported in terms of 30-day and 1-year observed mortality, and estimated 1-year survival in the learning and later phase of TAo TAVI. CONCLUSION: TAo TAVI can be performed safely even in the very early phase of the learning curve. Although satisfactory results can be achieved from the beginning, a significant reduction in contrast agent use and radiological exposure are expected as the technique is mastered. Good hemodynamics have been documented and should be further improved with modifications achieved in the TAVI self-expandable valves technology.

Percutaneous treatment of mitral regurgitation in patients with impaired ventricular function: Impact of intracardiac electronic devices (from the German Transcatheter Mitral Valve Interventions Registry).

OBJECTIVES: To identify prevalence/impact of previous implantation of cardiac electronic devices (CEDs), such as cardioverter defibrillator (ICD) and cardiac resynchronization (CRT), in a group of MitraClip (MC) candidates with LVEF < 30%. BACKGROUND: MC therapy is nowadays often considered in patients with depressed left ventricular ejection fraction (LVEF%) and symptomatic severe secondary MR. METHODS: Data from the German Transcatheter Mitral Valve Interventions (TRAMIs) registry were analyzed. Patients with pre-procedural LVEF <30% were selected and divided according to the presence of CEDs. Pre-procedural, peri-procedural, and 1-year follow-up data were analyzed. RESULTS: Out of 689 MC patients, 235 had LVEF<30%. Of these, 23% (54/235) had CRT, 36.6% (86/235) ICD, and 40.4% (95/235) had no CEDs. Risk profile was similar (median STS score CRT 6.0 (IQR: 3.0-12.0); ICD 7.0 (IQR: 4.0-12.0); No-CED 6.5 (IQR: 2.0-10.0); p = 0.8). No procedural mortality was observed and hospital mortality was 5.6% in CRT, 2.3% in ICD, and 3.2% in No-CED (p = 0.5). At discharge, severe MV regurgitation was reported in 3.8% of CRT, 3.7% of ICD, and 1.1% of No-CED (p = 0.9). One year estimated survival (CRT 75.7%; ICD 75.8%; No-CED 78%; p = 0.94) and freedom from MACCE (CRT 73.6%; ICD 75.8%; No-CED 74.5%; p = 0.88) were similar. CONCLUSIONS: A third of patients have been already submitted to CEDs implantation at time of referral for MC therapy and 40% of those with severely depressed LVEF% arrive to MC therapy before ICD/CRT implantation. The presence of CED does not impair acute MC therapy success. Mid-term follow-up outcomes are similar in patients with and without CEDs.

Prevalence and Progression of Cognitive Impairment in Atrial Fibrillation Patients after Treatment with Catheter Ablation or Drug Therapy.

PURPOSE: In atrial fibrillation (AF) patients, the effect of catheter ablation or drug therapy on cognition is currently not well investigated. Therefore, we prospectively evaluated AF patients who were either treated 'with drug therapy or underwent catheter ablation for the prevalence and progression of cognitive impairment (CI). METHODS: Randomized participants of the CABANA trial (catheter ablation versus antiarrhythmic drug therapy for atrial fibrillation) and the CASTLE-AF (catheter ablation versus standard conventional treatment in patients with left ventricular dysfunction and atrial fibrillation) study were assessed twice within 6 months by Montreal Cognitive Assessment (MoCA) and Mini-Mental State Examination (MMSE) in our institution. RESULTS: Forty-five patients from both trials were investigated, and twenty-eight patients received catheter ablation, whereas seventeen patients received drug therapy for rhythm or rate control. The mean age of the twenty-one CABANA trial patients (AF group) was 68.8 ± 7.0 years and of the twenty-four CASTLE-AF study patients (AF/HF group) was 66.8 ± 8.1 years, respectively. Mean time from ablation/randomization to the first interview was 16.8 ± 11 months in the AF group and 28.3 ± 18.4 months in the AF/HF group, respectively. All patients investigated were classified as cognitively impaired with mean cutoff scores <24 by MoCA. Overall, we could not detect significant differences in medically treated versus catheter ablation patients within both groups in mean MMSE or MoCA scores between the first and the second interview (p > 0.09). Moreover, patients who received catheter ablation did not show statistically significant differences in the prevalence or progression of cognitive impairment compared to patients who were treated medically, neither within the two groups nor between AF and AF/HF patients (p > 0.05). CONCLUSIONS: Prevalence of cognitive impairment in AF patients with comorbidities is substantial. However, in this preliminary prospective study, no apparent impact of AF pretreatment on the prevalence and course of cognitive impairment could be observed.

Transcatheter aortic valve implantation with a mechanically expandable prosthesis: a learning experience for permanent pacemaker implantation rate reduction.

BACKGROUND: Permanent pacemaker implantation (PPMI) after transcatheter aortic valve implantation (TAVI) remains an issue open for criticism. Aim of this study is to investigate a strategy to reduce PPMI rate after TAVI in general and more specifically after implantation of the LOTUS® prosthesis. METHODS: Through our learning curve, we have developed a structured protocol to reduce PPMI rate. The protocol includes: shallow implantation depth within the native annulus, strict adherence to the international guidelines for PPMI, PPMI not earlier than 5 days after TAVI, and intravenous chronotropic and steroidal treatment (orciprenaline 0.6-1.7 mg/h i.v. and dexamethasone 25 mg/day i.v. for a maximum of 5 days) in case of acute onset of intraventricular and/or atrio-ventricular conduction disturbances after TAVI. RESULTS: The first 35 patients (group A) were managed as per routine in our early stage experience with the LOTUS valve. The PPMI reduction protocol was applied in the second phase on the last 31 patients (group B). The PPMI rate was reduced from 34.3% (12/35) to 9.7% (3/31) (p = 0.02). At logistic regression analysis being treated in the second phase of our experience (group B) had a protective effect against PPMI (p = 0.05; OR = 0.1; CI = 0.01-1.0). Prosthesis implantation depth was directly related to PPMI (p = 0.005; OR = 2.0; CI = 1.2-3.2). Receiver operating characteristic curve analysis confirmed that a LOTUS implantation depth > 4.8 mm was the cut-off to predict PPMI (AUC = 0.8; p = 0.003; CI = 0.6-0.9) with maximal sensitivity (78.6%) and specificity (73.2%). CONCLUSIONS: PPMI rate after LOTUS can be reduced with experience by applying specific clinical and operative strategies.

Shocks after implantable cardioverter-defibrillator implantation in idiopathic cardiomyopathy patients: a myocardial biopsy study.

Prediction of follow-up shock is crucial to stratify patients with dilated cardiomyopathy (DCM) requiring implantable cardioverter defibrillator (ICD). The objective of the article is to assess the predictive value of endo-myocardial biopsy (EMB) towards ICD shock and follow-up mortality. A series of patients with DCM scheduled for ICD implantation underwent EMB to further determine the genesis of DCM. Presence of fibrosis and inflammation was documented and related to outcomes. A total of 240 patients were referred for ICD as primary (56%) and secondary (44%) prophylaxis. EMB showed myocardial fibrosis in 55.4%, inflammation in 55.7%, and viral genomic material in 60%. Median follow-up was 39 months (1-209). Appropriate and inappropriate shocks occurred in 29.2 and 20.4%. At logistic regression, determinants of appropriate shock were ICD indication for secondary prophylaxis (direct relationship: p = 0.009, OR 3.4, CI 1.3-8.8) and presence of inflammation at EMB (inverse relationship: p = 0.04, OR 0.4, CI 0.1-0.9). Moreover, the sole determinant of inappropriate shock was age at implant (inverse relationship: p = 0.003, OR = 0.9, CI 0.90-0.98). Overall mean estimated survival was 168 months and 5-year survival was 83%. Degree of improvement in LVEF% was the sole determinant of follow-up mortality (inverse relationship p = 0.02; HR = 0.9; CI 0.88-0.99). Present selection criteria for ICDs implant rely mainly on LVEF% that lacks sensitivity and specificity. EMB can identify the substrate of increased or reduced life-threatening arrhythmias. Presence of inflammation is a positive prognostic factor for reduced arrhythmogenic risk, independently by the ICD implantation indication.

New generation cardioverter-defibrillator lead with a floating atrial sensing dipole: Long-term performance.

OBJECTIVES: The study aim is to present the long-term performance of a new generation implantable cardioverter defibrillator (ICD) electrode with floating atrial dipole (Linox S DX, Biotronik, Berlin, Germany). BACKGROUND: The single ICD electrode with a floating dipole in the atrial chamber was introduced about 15 years ago to overcome risk of inappropriate shock. METHODS: After implantation, internal electrocardiogram data were prospectively collected via telemonitoring (Home Monitoring, Biotronik). RESULTS: A total of 93 patients (81.5% male, 18.5% female; 58.9 ± 12.3 years) were implanted with a single-chamber ICD using the Linox S DX. Patients were followed up for a median of 693 days (33-2,460 days). At time of implantation average p-wave value was 3.5 ± 1.7 mV and remained stable throughout follow-up with an average value of 3.7 ± 1 mV (P = 0.2). A total of 460 arrhythmic episodes were recorded and 185 (40.2%) were incorrectly stratified by the device software. Seven patients (7.5%) experienced inappropriate ICD therapy. In three patients, VT episodes were not detected and remained untreated. CONCLUSIONS: Although the Linox S DX lead presents a satisfactory long-term stability of the atrial sensing, many of the messages sent to the device during follow-up were incorrectly classified by the ICD software. As a result, inappropriate therapy occurred with a rate similar to that observed with dual-chamber ICDs, but some malignant arrhythmias remained undiagnosed and untreated while occurring. Results in larger prospective cohorts should be analyzed and software improvements of the device should be suggested to overcome these potential drawbacks.

Coronary sinus signal amplitude predicts left atrial scarring.

BACKGROUND: Left atrial scarring is recognised as a critical component in the maintenance of atrial fibrillation and is associated with the failure of interventional treatment. Diminished bipolar voltage (LV) has been proposed as a useful tool for left atrial scar quantification. We hypothesised that, due to its anatomic location, signals on the coronary sinus catheter might be used to predict the amount of left atrial low voltage. METHODS AND RESULTS: A total of 124 patients (42% women, average age 66 ± 9 years) were included. Forty-one with paroxysmal and 83 with persistent atrial fibrillation. Left atrial low-voltage (<0.5 mV, measured during sinus rhythm) area size and distribution varied considerably among the included patients (mean: 34.9%; maximum: 94.6%; minimum: 0.4%). Spearman correlation revealed a strong negative correlation between bipolar voltage of the signals on the coronary sinus catheter and the amount of left atrial scarring (R = -0.778, p < .0001). The optimal CS voltage cut off for prediction of left atrial low-voltage size of ≥50% was 1.9 mV with an area-under-the receiver-operating-characteristic (ROC) curve of 0.982, a sensitivity of 97% and a specificity of 98%. CONCLUSIONS: There is a strong negative correlation between the size of left atrial low-voltage areas (LVA) and coronary sinus signal amplitude. With increasing left atrial LVA size, CS signal amplitudes decrease, and vice versa. On the basis of these findings, average CS signal amplitudes of ≤1.9 mV can be used as a predictor for a left atrial low-voltage size of ≥50%.

Activation of remote monitoring for cardiac implantable electronic devices: small dog for tall weeds.

BACKGROUND: Remote monitoring (RM) of cardiac implantable electronic devices (CIEDs) has been popularized as a precious patients' management tool. We have investigated RM within the premises of a multicenter, prospective, real-world registry, i.e., the German Device II. METHODS: We have focused on: (1) CIEDs with RM capabilities implantation rate and (2) actual rate of RM features activation. RESULTS: A cohort of 1223 CIEDs patients were treated from 04/11 to 02/14. Of these, 720 (58.8%) were implanted with RM-capable devices and were presenting significantly more often a clinical diagnosis of dilatative cardiomyopathy and an indication for cardiac resynchronization. At discharge, the RM feature was activated in only 12.6% (91/720) of the total number of patients implanted with RM-capable CIEDs. After adjusting for implanting center, there was no significant correlation between any of the patient clinical characteristics and RM activation. One-year estimated mortality was 9.0% in patients with activated RM, 5.6% in those with not activated RM, and 7.7% in those without RM capability (p = 0.3). The RM feature was still activated in 13.8% of the patients surviving at follow-up. Patients undergoing RM had a trend for higher re-hospitalization rate and less visits in the device outpatient clinic. CONCLUSIONS: Although RM in CIEDs may be a clinically valuable technological armamentarium, its activation does not reflect patients' clinical profile. In fact, RM is often not activated, most probably because it is still recognized as a source of increased workload in a reality where reimbursement plans for dedicated human resources are not yet optimized.

Combined mitro-aortic pathology: impact of previous aortic valve replacement upon outcomes of MitraClip therapy (from the German transcatheter mitral valve interventions registry).

AIMS: The aim of this study was to identify the impact of previous aortic valve replacement (AVR) in MitraClip (MC) patients. METHODS AND RESULTS: Data from the German transcatheter mitral valve interventions (TRAMI) registry were analysed in the light of previous AVR by means of either standard AVR (SAVR) or transcatheter AVR (TAVR). Out of 791 MC patients, 68 (8.6%) had been submitted to AVR (68.4% SAVR and 31.6% TAVR). The AVR group was significantly older (77.2±8.0 years vs. 75.1±8.6 years; p<0.05) and had a trend towards a higher risk profile (median STS score 10 [8.0-12.0] vs. 6.0 [3.0-11.0]; p=0.1). No procedural mortality was observed. Severe residual MV regurgitation was reported in 6.2% of AVR vs. 3.7% of the no-AVR patients (p=0.1). Thirty-day mortality was 10.6% in the previous AVR group vs. 3.9% in the no-AVR group (p<0.05). One-year estimated survival was lower in the AVR group (AVR 63% vs. no-AVR 81%; p<0.0001; HR 2.25, 95% CI: 1.42-3.55). Estimated survival in TAVR compared to SAVR was lower (TAVR 44.4% vs. SAVR 70%; p=0.039; HR 2.32, 95% CI: 0.99-5.37). AVR was a determinant of follow-up mortality (HR 2.18, 95% CI: 1.4-3.4; p<0.001). CONCLUSIONS: Previous AVR in patients undergoing MC therapy carries a heavy and independent burden of mortality/morbidity.

Clinical efficacy and safety of an implantable cardioverter-defibrillator lead with a floating atrial sensing dipole.

BACKGROUND: The concept of a single-lead implantable cardioverter-defibrillator (ICD), with a floating dipole, has been proven safe and functional. METHODS AND RESULTS: The studied active-fixation, steroid-eluting lead (Linox(smart) S DX, BIOTRONIK SE & Co KG, Berlin, Germany) is one French thinner than its predecessor and coated with lubricious SilGlide to improve lead handling. A dedicated ICD device has a self-adaptive atrial input stage including a fourfold amplifier. The amplification, filtering, and adapted atrial input stage are located in the Lumax 540 VR-T DX (BIOTRONIK). The Linox(smart) S DX ICD lead delivers only the signal. The lead was evaluated during implantation; at predischarge; and 1-, 3-, and 6-month follow-up examinations. The primary endpoint (efficacy) was the rate of appropriate atrial sensing tests. The secondary endpoint (safety) was freedom from lead-related invasive reinterventions. Both safety and efficacy were expected to be significantly higher than 90%. The study enrolled 116 patients at 25 clinical sites. Skin-to-skin operation time was 52.4 ± 26.2 minutes. The investigators graded lead insertion as "easy" in 87% of patients. Mean P-wave amplitudes (preamplified) varied from 5.0 to 6.1 mV in different body positions. Both primary and secondary endpoints were met, as 93.8% (364/388; P = 0.005) of specific sensing tests indicated appropriate atrial sensing, and 94.8% (110/116; P = 0.048) of patients were free from reinterventions (lead dislodgement). Analysis of arrhythmia episodes stored in ICDs and elective 24-hour Holter electrocardiogram tests raised no concerns about lead functionality. CONCLUSION: The studied ICD lead with a floating atrial sensing dipole met the predefined safety expectation and demonstrated appropriate atrial sensing performance.