Pacing Using Cardiac Implantable Electric Device During TAVR: 10-Year Experience of a High-Volume Center.

BACKGROUND: Transcatheter aortic valve replacement (TAVR) is an effective and safe therapy for severe aortic stenosis. Rapid or fast pacing is required for implantation, which can be performed via a pre-existing cardiac implantable electric device (CIED). However, safety data on CIEDs for pacing in TAVR are missing. OBJECTIVES: The aim of this study was to elucidate procedural safety and feasibility of internal pacing with a CIED in TAVR. METHODS: Patients undergoing TAVR with a CIED were included in this analysis. Baseline characteristics, procedural details, and complications according to Valve Academic Research Consortium 3 (VARC-3) criteria after TAVR were compared between both groups. RESULTS: A total of 486 patients were included. Pacing was performed using a CIED in 150 patients and a transient pacemaker in 336 patients. No differences in technical success according to VARC-3 criteria or procedure duration occurred between the groups. The usage of transient pacers for pacing was associated with a significantly higher bleeding rate (bleeding type ≥2 according to VARC-3-criteria; 2.0% vs 13.1%; P < 0.01). Furthermore, impairment of the CIED appeared in 2.3% of patients after TAVR only in the group in which pacing was performed by a transient pacer, leading to surgical revision of the CIED in 1.3% of all patients when transient pacemakers were used. CONCLUSIONS: Internal pacing using a CIED is safe and feasible without differences of procedural time and technical success and might reduce bleeding rates. Furthermore, pacing using a CIED circumvents the risk of lead dislocation. Our data provide an urgent call for the use of a CIED for pacing during a TAVR procedure in general.

Prevalence, management, and prediction of venous access site occlusion in patients undergoing lead revision surgery.

BACKGROUND: Implantable electronic cardiac devices (CIED) have emerged as an essential component in the treatment of cardiac arrhythmias and heart failure. Due to increased life expectancy, expanding indications and limited technical survival, an increasing number of revision procedures can be anticipated. Venous access site occlusion (VASO) is the main obstacle during revision surgery. In this retrospective study we evaluated the prevalence, predictive parameters and operative management of venous access site occlusion. METHODS AND RESULTS: Between 01/2016 and 12/2020 304 patients underwent lead revision surgery of transvenous CIED in our department. Prevalence of VASO was 25.7% (n = 78), one patient was symptomatic. Independent predicting clinical parameters were male sex (2.86 (1.39-5.87), p < 0.01) and lead age (1.11 (1.05-1.18), p < 0.01)). Revision surgery despite VASO was successful in 97.4% (n = 76) without prolongation of the total surgery time or higher complication rates. Yet, lead extraction was possible in 92% of patients with VASO vs. 98.2% of patients without VASO (p 0.01). CONCLUSION: VASO is a frequent condition in patients undergoing lead revision surgery, but successful revision is feasible in most cases without preceding lead extraction. However, the lower success rates of lead extractions may be prognostically relevant, especially for younger patients.

Impact of mitral regurgitation aetiology on the outcomes of transcatheter aortic valve implantation.

BACKGROUND: Concomitant moderate/severe mitral regurgitation (MR) is observed in 17-35% of patients undergoing transcatheter aortic valve implantation (TAVI) and contributes to a worse prognosis. Studies analysing outcomes in patients undergoing TAVI with different MR aetiologies, including atrial functional MR (aFMR), are lacking. AIMS: We aimed to analyse outcomes and changes in MR severity in patients with aFMR, ventricular functional (vFMR) and primary mitral regurgitation (PMR) following TAVI. METHODS: We analysed all consecutive patients with at least moderate MR undergoing TAVI between January 2013 and December 2020 at the Munich University Hospital. Characterisation of MR aetiology was performed by detailed individual echocardiographic assessment. Three-year mortality, changes in MR severity and New York Heart Association (NYHA) Functional Class at follow-up were assessed. RESULTS: Out of 3,474 patients undergoing TAVI, 631 patients showed MR ≥2+ (172 with aFMR, 296 with vFMR, 163 with PMR). Procedural characteristics and endpoints were comparable between groups. The rate of MR improvement was 80.2% in aFMR patients, which was significantly higher compared to both other groups (vFMR: 69.4%; p=0.03; PMR: 40.8%; p<0.001). The estimated 3-year survival rates did not differ between aetiologies (p=0.57). However, MR persistence at follow-up was associated with increased mortality (hazard ratio 1.49, 95% confidence interval: 1.04-2.11; p=0.027), mainly driven by the PMR subgroup of patients. NYHA Class improved significantly in all groups. In patients with baseline MR ≥3+, the PMR aetiology was associated with the lowest MR improvement, the lowest survival rates and least symptomatic improvement. CONCLUSIONS: TAVI reduces MR severity and symptoms in patients with aFMR, vFMR and less-pronounced PMR. The presence of aFMR was associated with the greatest MR severity improvement.

Quantification of physical activity with prospective activity tracking after transfemoral aortic valve replacement.

BACKGROUND: Transcatheter aortic valve replacement (TAVR) is a well-established, safe and effective therapy for severe symptomatic aortic stenosis (AS). The aim of this study was to objectively quantify improvement of physical activity after TAVR, with consideration of different low-gradient AS subtypes. METHODS AND RESULTS: All patients undergoing TAVR for severe AS were screened. Participants received a wearable activity tracker (Fitbit®) at hospital discharge following TAVR and 6 months thereafter. The difference of median daily steps was defined as surrogate outcome for physical activity. For analysis, patients were grouped into high-gradient (HG) AS (dPmean ≥40 mmHg), classical low-flow low-gradient (LFLG) AS (dPmean <40 mmHg, EF <50%), paradoxical LFLG-AS (dPmean <40 mmHg, EF ≥50%, SVi ≤35 ml/m2) and normal-flow low-gradient (NFLG) AS (dPmean <40 mmHg, EF ≥50%, SVi >35 ml/m2) according to mean transvalvular pressure gradient (dPmean), stroke volume index (SVi) and left-ventricular ejection fraction (LVEF). RESULTS AND CONCLUSIONS: The analysis is based on 230 patients. The median daily step count was 4409 [IQR 2581-7487] after hospital discharge and 5326 [IQR 3045-8668] 6 months thereafter. Median difference of daily steps was ∆529 [IQR -702-2152]). Patients with HG-AS and paradoxical LFLG-AS showed a significant improvement of daily steps (∆951 [IQR -378-2323], p <0.001 and (∆1392 [IQR -609-4444], p = 0.02, respectively). Patients with classical LFLG-AS showed no statistically relevant improvement of daily steps (∆192 [IQR -687-770], p = 0.79). Patients with NFLG-AS showed a numerical decline in daily steps without statistical significance (∆-300 [IQR -1334-1406], p = 0.67). This first prospective study of this sample size shows significant improvement of physical activity after TAVR with an objective and reproducible method. This was mainly driven by an improvement in patients with HG-AS and paradoxical LFLG-AS.

Simplified ELASTA-CLIP Before Transapical Mitral Valve Replacement.

Residual and recurrent mitral regurgitation after transcatheter edge-to-edge repair are therapeutically challenging. In the present case report, we describe a simplified, transapical electrosurgical laceration and stabilization of clip procedure that represents an alternative and direct approach for electrosurgical laceration of mitral valve leaflets enabling transcatheter mitral valve replacement for recurrent mitral regurgitation after mitral valve transcatheter edge-to-edge repair.

Impairment of Quality of Life in Patients with Implanted Subcutaneous Cardioverter Defibrillator (S-ICD) Compared to Implanted Transvenous Cardioverter Defibrillator Therapy.

Background: The subcutaneous cardioverter defibrillator (S-ICD) has been shown to be a viable alternative to transvenous ICDs (TV-ICD) in all patients at risk of sudden cardiac death (SCD) but without pacing indication. Aim: The aim of this study was to examine the impact of therapy with current S-ICD devices on quality of life (QoL) in comparison to patients with TV-ICD devices. Methods: In our single-centre study, 52 consecutive patients with S-ICD and 52 matched patients with TV-ICD were analysed. QoL has been assessed by a standardized questionnaire (EQ-5D-3L, modified). Additionally, clinical baseline and follow-up data were evaluated. Results: Two-thirds of the total study population reported restrictions in daily routine compared to their life before ICD implantation. A total of 27.7% of S-ICD patients stated to expect an improvement of QoL by deactivation or explantation of their defibrillator compared to only 6.4% of patients with TV-ICD (p=0.006), which was mainly caused by discomfort and pain from the S-ICD pocket (relevant discomfort and pain in 32.6% vs 11.5%; p<0.01). Limitations: Main limitation of the study is that quality of life was assessed for one single time point only and time since implantation differed significantly between S-ICD and TV-ICD. Furthermore our collective is younger, and, due to the high proportion of patients without cardiomyopathy, the mean EF is better than usual ICD collective. The absence of heart failure in about the half of our patients might have relevant impact on our QoL analysis. Conclusion: A relevant proportion of S-ICD patients expects an improvement of QoL by explantation of the device. Of note, this impression was not driven by the fear of receiving shocks but mainly by discomfort and pain caused by the pulse generator.

Dual ProGlide versus ProGlide and FemoSeal for vascular access haemostasis after transcatheter aortic valve implantation.

BACKGROUND: Large-bore arteriotomy for transcatheter aortic valve implantation (TAVI) requires percutaneous vascular closure devices, but real-world data comparing different closure strategies are limited. AIMS: We sought to compare a dual ProGlide strategy vs a combination of one ProGlide and one FemoSeal for vascular closure after TAVI. METHODS: We retrospectively analysed 874 propensity score-matched patients undergoing TAVI at the Munich University Hospital from August 2018 to October 2020. From August 2018 to August 2019, a dual ProGlide strategy was used for vascular closure. From October 2019 to October 2020, a combination of one ProGlide and one FemoSeal was used. The primary endpoint was defined as access-related major vascular complications or bleeding ≥Type 2 according to Valve Academic Research Consortium 3 criteria. RESULTS: Patients in the dual ProGlide group (n=437) had a higher incidence of the primary endpoint than patients treated with one ProGlide and one FemoSeal (n=437; 11.4% vs 3.0%; p<0.001). Furthermore, they had a higher rate of closure device failure (2.7% vs 0.9%; p=0.044) and more often required unplanned surgery or endovascular treatment (3.9% vs 0.9%; p=0.004). The incidence of death did not differ significantly between groups (3.4% vs 1.6%; p=0.08). CONCLUSIONS: A combined ProGlide and FemoSeal strategy might have the potential to reduce access-related vascular complications following TAVI.

Surgery for Aortic Prosthetic Valve Endocarditis in the Transcatheter Era.

Objectives: As surgical experience with infective endocarditis following transcatheter aortic valve replacement is scarce, this study compared the perioperative and short-term outcomes of patients suffering from endocarditis following surgical aortic valve replacement and transcatheter aortic valve replacement. Methods: Between January 2013 and December 2020, 468 consecutive patients were admitted to our center for surgery for IE. Among them, 98 were operated on for endocarditis following surgical aortic valve replacement and 22 for endocarditis following transcatheter aortic valve replacement. Results: The median EuroSCORE II (52.1 (40.6-62.0) v/s 45.4 (32.6-58.1), p = 0.207) and STS-PROM (1.8 (1.6-2.1) v/s 1.9 (1.4-2.2), p = 0.622) were comparable. Endocarditis following transcatheter aortic valve replacement accounted for 13.7% of the aortic prosthetic valve endocarditis between 2013 and 2015; this increased to 26.9% in the years 2019 and 2020.Concomitant procedures were performed in 35 patients (29.2%). The operative mortality was 26.5% in the endocarditis following surgical aortic valve replacement group and 9.1% in the endocarditis following transcatheter aortic valve replacement group (p = 0.098). Upon follow-up, survival at 6 months was found to be 98% in the group with endocarditis following surgical aortic valve replacement and 89% in the group with endocarditis following transcatheter aortic valve replacement (p = 0.081). Conclusions: Patients suffering from endocarditis following surgical aortic valve replacement and transcatheter aortic valve replacement present with comparable risk profiles and can be surgically treated with comparable results. Surgery as a curative option should not be rejected even in this intermediate-risk cohort.

TAVI in patients with low-flow low-gradient aortic stenosis-short-term and long-term outcomes.

OBJECTIVES: The study objective was to characterize different groups of low-flow low-gradient (LFLG) aortic stenosis (AS) and determine short-term outcomes and long-term mortality according to Valve Academic Research Consortium-3 (VARC-3) endpoint definitions. BACKGROUND: Characteristics and outcomes of patients with LFLG AS undergoing transcatheter aortic valve implantation (TAVI) are poorly understood. METHODS: All patients undergoing TAVI at our center between 2013 and 2019 were screened. Patients were divided into three groups according to mean pressure gradient (dPmean), ejection fraction (LVEF), and stroke volume index (SVi): high gradient (HG) AS (dPmean ≥ 40 mmHg), classical LFLG (cLFLG) AS (dPmean < 40 mmHg, LVEF < 50%), and paradoxical LFLG (pLFLG) AS (dPmean < 40 mmHg, LVEF ≥ 50%, SVi ≤ 35 ml/m2). RESULTS: We included 1776 patients (956 HG, 447 cLFLG, and 373 pLFLG patients). Most baseline characteristics differed significantly. Median Society of Thoracic Surgeons (STS) score was highest in cLFLG, followed by pLFLG and HG patients (5.0, 3.9 and 3.0, respectively, p < 0.01). Compared to HG patients, odds ratios for the short-term VARC-3 composite endpoints, technical failure (cLFLG, 0.76 [95% confidence interval, 0.40-1.36], pLFLG, 1.37 [0.79-2.31]) and device failure (cLFLG, 1.06 [0.74-1.49], pLFLG, 0.97 [0.66-1.41]) were similar, without relevant differences within LFLG patients. NYHA classes improved equally in all groups. Compared to HG, LFLG patients had a higher 3-year all-cause mortality (STS score-adjusted hazard ratios, cLFLG 2.16 [1.77-2.64], pLFLG 1.53 [1.22-193]), as well as cardiovascular mortality (cLFLG, 2.88 [2.15-3.84], pLFLG, 2.08 [1.50-2.87]). CONCLUSIONS: While 3-year mortality remains high after TAVI in LFLG compared to HG patients, symptoms improve in all subsets after TAVI.

Transcatheter Aortic Valve Replacement with the Self-Expandable Core Valve Evolut Prosthesis Using the Cusp-Overlap vs. Tricusp-View.

Despite the rapid increase in experience and technological improvement, the incidence of conduction disturbances in patients undergoing transcatheter aortic valve replacement (TAVR) with the self-expandable CoreValve Evolut valve remains high. Recently, a cusp-overlap view (COP) implantation technique has been proposed for TAVR with self-expandable valves offering an improved visualization during valve expansion compared to the three-cusp view (TCV). This study aims to systematically analyze procedural outcomes of TAVR patients treated with the CoreValve Evolut valve using a COP compared to TCV in a high-volume center. The primary endpoint was technical success according the 2021 VARC-3 criteria. A total of 122 consecutive patients (61 pts. TCV: April 2019 to November 2020; 61 pts. COP: December 2020 to October 2021) that underwent TAVR with the CoreValve Evolut prosthesis were included in this analysis. Although there was no difference in the primary endpoint technical success between TCV and COP patients (93.4% vs. 90.2%, OR 0.65, 95% CI 0.16, 2.4, p = 0.51), we observed a significantly lower risk for permanent pacemaker implantation (PPI) among COP patients (TCV: 27.9% vs. COP: 13.1%, OR 0.39, 95% CI 0.15, 0.97, p = 0.047). Implantation of the CoreValve Evolut prosthesis using the COP might help to reduce the rate of PPI following TAVR.

Hybrid Surgery for Severe Mitral Valve Calcification: Limitations and Caveats for an Open Transcatheter Approach.

Background and Objectives: Mitral stenosis with extensive mitral annular calcification (MAC) remains surgically challenging in respect to clinical outcome. Prolonged surgery time with imminent ventricular rupture and systolic anterior motion can be considered as a complex of causal factors. The aim of our alternative hybrid approach was to reduce the risk of annual rupture and paravalvular leaks and to avoid obstruction of the outflow tract. A review of the current literature was also carried out. Materials and Methods: Six female patients (mean age 76 ± 9 years) with severe mitral valve stenosis and severely calcified annulus underwent an open implantation of an Edwards Sapien 3 prosthesis on cardiopulmonary bypass. Our hybrid approach involved resection of the anterior mitral leaflet, placement of anchor sutures and the deployment of a balloon expanded prosthesis under visual control. Concomitant procedures were carried out in three patients. Results: The mean duration of cross-clamping was 95 ± 31 min and cardiopulmonary bypass was 137 ± 60 min. The perioperative TEE showed in three patients an inconspicuous, heart valve-typical gradient on all implanted prostheses and a clinically irrelevant paravalvular leakage occurred in the anterior annulus. In the left ventricular outflow tract, mild to moderately elevated gradients were recorded. No adverse cerebrovascular events and pacemaker implantations were observed. All but one patient survived to discharge. Survival at one year was 83.3%. Conclusions: This "off label" implantation of the Edwards Sapien 3 prosthesis may be considered as a suitable bail-out approach for patients at high-risk for mitral valve surgery or deemed inoperable due to extensive MAC.

Permanent pacemaker dependency in patients with new left bundle branch block and new first degree atrioventricular block after transcatheter aortic valve implantation.

Conduction disorders with need for permanent pacemaker (PPM) implantation remain frequent complications after transcatheter aortic valve implantation (TAVI). Up to 22% of PPM after TAVI are implanted for new onset left bundle branch block (LBBB) and atrioventricular block (AVB) I. However, clinical benefit and predictors of ventricular pacing in TAVI patients receiving PPM for this indication remain unclear. We retrospectively evaluated pacemaker interrogation data of patients who received a PPM post TAVI for new LBBB and new AVB I. The primary endpoint of this study was relevant ventricular pacing (ventricular pacing rate: Vp ≥ 1%) at the first outpatient pacemaker interrogation. Secondary endpoints were predictors for relevant ventricular pacing. At the first pacemaker interrogation (median follow up at 6.23 [2.8-14.8] months), median ventricular pacing frequency was 1.0% [0.1-17.8]. Out of 61 patients, 36 (59%) had Vp rates ≥ 1%. Patients with frequent ventricular pacing showed longer QRS duration (155 ms ± 17 ms vs. 144 ms ± 18 ms, p = 0.018) at the time of PPM implantation and were less likely treated with a balloon-expandable Edwards Sapiens Valve (39% vs. 12%, p = 0.040). Our findings suggest that the majority of patients with new LBBB and new AVB I after TAVI show relevant ventricular pacing rates at follow up. Further prospective studies are necessary to identify patients at higher risk of pacemaker dependency.

Survival after left ventricular assist device implantation correlates with a novel device-based measure of heart rate variability: the heart rate score.

OBJECTIVES: The heart rate score (HRS) serves as a device-based measure of impaired heart rate variability and is an independent predictor of death in patients with heart failure and a cardiac implantable electrical device. However, no data are available for predicting death from the HRS in patients with end stage heart failure and a left ventricular assist device. METHODS: From November 2011 to July 2018, a total of 56 patients with a pre-existing cardiac implantable electrical device underwent left ventricular assist device implantation at our 2 study sites. The ventricular HRS was calculated retrospectively during the first cardiac implantable electrical device follow-up examination following the index hospitalization. Survival during follow-up was correlated with initial HRS. RESULTS: During the follow-up period, 46.4% of the patients (n = 26) died. The median follow-up period was 33.2 months. The median HRS after the index hospitalization was 41.1 ± 21.8%. More patients with an HRS >65% died compared to patients with an HRS <30% (76.9% vs 14.4%; P = 0.007). CONCLUSIONS: In our multicentre experience, survival of patients after an left ventricular assist device implant correlates with the HRS. After confirmation of our findings in a larger cohort, the effect of rate-responsive pacing will be within the scope of further investigation.

Cardiac surgery following transcatheter aortic valve replacement.

OBJECTIVES: The objective of this study was to retrospectively analyse surgical outcomes of patients undergoing secondary cardiac surgery after initial transcatheter aortic valve replacement (TAVR). METHODS: Between December 2012 and February 2020, a total of 41 consecutive patients underwent cardiac surgery after a TAVR procedure at our institution. Patients who underwent emergency operations due to periprocedural complications such as ventricular rupture and TAVR dislocation were excluded from this study (n = 12). Thus, 29 patients were included in the analysis. Data are presented as medians (25th-75th quartiles) or as absolute numbers (percentages). RESULTS: The median age was 76 years (68-80); 58.6% were men. The median time to a secondary conventional procedure was 23 months (8-40), with 8 patients requiring surgical intervention within the first year post TAVR. The indications for secondary conventional procedures were prosthesis endocarditis (n = 15), prosthesis degeneration or dysfunction (n = 7) and progression of valvular, aortic or coronary artery disease (n = 7). Surgical redo aortic valve replacement was performed in 24 patients (82.8%). No complications involving the aortic root or the aortomitral continuity were observed. The operative mortality was 10.3%. Extracorporeal life support was required in 3 patients (10.3%) for a median duration of 3 days (3-3 days). No adverse cerebrovascular events were observed postoperatively. Postoperatively, 4 patients (13.8%) required a pacemaker and 7 patients (24.1%) required renal replacement therapy. Overall survival at 1 year was 83.0%. CONCLUSIONS: Conventional cardiac surgical procedures following TAVR are feasible with reasonable results and a low complication rate.

TAVR in nonagenarians: An analysis investigating safety, efficacy, symptomatic improvement, and long-term survival.

BACKGROUND: In the aging western societies, an increasing prevalence of severe, symptomatic aortic stenosis is observed. The aim of this study was to examine the safety and efficacy of transcatheter aortic valve replacement (TAVR) in patients aged 90 years and older. METHODS: All patients with severe symptomatic aortic stenosis undergoing TAVR at LMU Munich-University-Hospital between 2013 and 2018 were included. Procedure-related mortality (<30 days) was defined as the primary endpoint and survival rates at two years, device failure, and procedural complications were defined as secondary endpoints according to the Valve Academic Research Consortium II criteria. RESULTS AND CONCLUSIONS: Out of 2336 patients, 2183 were younger than 90 years (<90y.-group) and 153 patients were aged 90 or older (≥90y.-group). Procedure-related mortality (3.6% <90y.-group vs. 3.3% ≥90y.-group, log-rank p=0.9) and device success (97.2% <90y.-group vs. 96.0% ≥90y.-group, p=0.44) were similar. Estimated survival rates at 2 years were 62.8% (95% CI 55.3 and 71.4) in the elder and 76.0% (95% CI 74.1 and 77.8) in the younger patients (p<0.01). The incidence of acute kidney injury, stroke, major bleeding, and permanent pacemaker implantations were comparable between both groups. TAVR procedure is equally safe and feasible in patients aged 90 years or older compared to younger patients. Differences in 2-year survival appear to be patient-related rather than procedure-related.

Tricuspid valve annuloplasty and mitral valve replacement are associated with bradyarrhythmia after mitral valve surgery.

INTRODUCTION: Mitral valve surgery has developed into a strong subspecialty of cardiac surgery with operative techniques and outcomes constantly improving. The development of bradyarrhythmias after mitral valve surgery is not completely understood. METHODS: We investigated a cohort of 797 patients requiring mitral valve surgery with and without concomitant procedures. Incidences and predictors of pacemaker requirement as well as survival were analyzed. RESULTS: In the complete follow-up period (median follow-up time: 6.09 years [95% confidence interval [CI]: 5.94-6.22 years, maximum 8.77 years) 80 patients (10% of the complete cohort) required pacemaker implantation for bradyarrhythmia. The cumulative rate of pacemaker implantation was 6.4% at 50 days (48 patients) with most (54.2%) requiring pacing for atrioventricular block. Mitral valve replacement (odds ratio [OR]: 1.905; 95% CI: 1.206-3.536; p = .041) and tricuspid ring annuloplasty (OR: 2.348; 95% CI: 1.165-4.730, p = .017) were identified as operative risk factors of pacemaker requirement after mitral valve surgery. Insulin-dependent diabetes mellitus was also identified as a predictor of pacemaker requirement (OR: 4.665; 95% CI: 1.975-11.02; p = .001). There was no difference in survival in the paced and unpaced groups. CONCLUSIONS: After mitral valve surgery, a relevant subgroup of patients requires pacemaker implantation-most for atrioventricular block. We identified mitral valve replacement and tricuspid ring annuloplasty as significant operative risk factors and insulin-dependent diabetes mellitus as a demographic risk factor. While anatomic relationships help explain the operative risk factors the role of diabetes mellitus is not completely understood.