Matthias Linder

Predictors and outcomes after transcatheter aortic valve implantation using different approaches according to the valve academic research consortium definitions

We report the results of a large single‐center study evaluating predictors and outcomes after transcatheter aortic valve implantation (TAVI) with different devices and access routes according to the Valve Academic Research Consortium (VARC).

Outcomes with a latest generation self-expandable, intra-annular, re-sheathable transcatheter heart valve system: analysis of patients with impaired left ventricular function and determinants for pacemaker implantation

ObjectivesWe herein report a single-center experience with the Portico TAVI system. Main focus was set on outcomes in patients with impaired left ventricular (LV) function and predictors for permanent pacemaker (PPM) implantation.MethodsBetween 05/2014 and 10/2017, 106 consecutive patients received TAVI using the Portico device. For comparison of patients with/without impaired LV function, and determination of multi-slice computed tomography and electrocardiogram correlates for PPM implantation subgroups were built (Subgroup I: LVEF ≥ 50%, n = 69, Subgroup II: LVEF < 50%, n = 37; Subgroup A: no PPM implantation, n = 89; Subgroup B: PPM implantation, n = 17). Data were retrospectively analyzed.ResultsDevice success was 95.3% (101/106) with resulting transvalvular peak/mean pressure gradients of 10.6 ± 5.6/5.4 ± 3.1 and PVL ≥ moderate in 5/106 patients (4.7%). 30-day mortality was 4.7% (5/106; subgroup I 3/69, 4.3%; subgroup II 2/37, 5.4%; p = 1.0). Regarding VARC-2 adjudicated clinical endpoints stroke (3/106, 2.8%; subgroups I/II: 2/69 vs. 1/37, p = 1.0) and acute kidney injury (9/106, 8.5%; subgroups I/II: 6/69 vs. 3/37, p = 1.0), no significant differences were found. Postprocedural PPM implantation occurred in 17.9% (19/106) of the patients. Logistic regression for PPM implantation demonstrated predictive character of left coronary cusp (LCC) calcium load in zone 1 (annular plane to coronary ostia) (p = 0.05, threshold 193 mm3) and total calcium load of zone 1 (p = 0.05, threshold 751.2 mm3).ConclusionsThe Portico valve demonstrates a satisfying safety outcome, especially for patients with impaired LV function. Results of the CE-mark trial were confirmed, except for higher PPM rates. PPM rates are in accordance with other reports on this TAVI platform.

Evaluation of tricuspid valve regurgitation following laser lead extraction

OBJECTIVES The objective of this study was to examine the effect of laser lead extraction (LLE) on the development of post-procedural tricuspid regurgitation (TR). Some reports have suggested an increase in TR associated with LLE. We present a series of patients who underwent both, LLE and complete echocardiographic evaluation for TR. METHODS A single centre analysis of consecutive patients referred for LLE between January 2012 and August 2015. One hundred and three patients had tricuspid valve function evaluated before the procedure with a transthoracic echocardiography (TTE), during the procedure using transoesophageal echocardiography and postoperatively using a TTE. TR was graded from 0 (none) to 4 (severe). RESULTS We treated 235 leads in 103 patients, including 118 ventricular leads. Seventy-seven were male (74.8%) and 26 female (25.2%), with a mean age of 65.6 ± 15.4 years. Mean time from initial lead implantation was 98.0 ± 67.3 months. Twenty-one patients (20.4%) had ejection fraction below 30%. No intra-procedural worsening of tricuspid valve function was seen with TEE in any of the patients. Ten patients (9.7%) were found to have TR before LLE that returned to normal valve function after the procedure. Two patients (1.9%) experienced mild TR after the procedure (both with tricuspid valve endocarditis). Ninety-one patients (88.3%) did not experience any significant change of the tricuspid valve function after LLE. CONCLUSION Transthoracic and transoesophageal echocardiography findings showed that laser lead extraction was not associated with a significant increase in the incidence of tricuspid valve regurgitation.

Lead extraction with high frequency laser sheaths: a single-centre experience

OBJECTIVES Extraction of chronically implanted cardiac implantable electrophysiological devices leads can be difficult. Excimer laser-assisted extraction with 40 Hz sheaths has shown good results in challenging cases. In 2012, a new 80 Hz high-frequency laser sheath became available that delivers twice as many pulses per second. Here, we report our clinical experience with the new GlideLight 80 Hz laser sheath. METHODS Between January 2012 and August 2016, 292 leads were treated in 151 patients using 80 Hz GlideLight laser sheath. Lead extraction indications included systemic infection or lead endocarditis n =  35 (23.2%), local infection n =  73 (48.3%), lead dysfunction n =  32 (21.2%), system upgrade n =  5 (3.3%), tricuspid regurgitation n =  3 (2.0%) and other indications n =  3 (2.0). All patient-related and procedural data were collected into a database and analysed. RESULTS Mean patients age was 66.2 ± 14.4 years, 73.5% were male. Ninety-one (31.2%) atrial, 159 (54.4%) ventricular and 42 (14.4%) coronary sinus leads had to be extracted. The mean time from initial lead implantation was 98.0 ± 65.2 months. Mean laser treatment time was 67.5 ± 71.3 s, mean laser pulses delivered were 5130 ± 6592. Clinical success was achieved in 99.3% of the cases, while complete procedural success was observed in 96.7%. A failure of extraction was seen in 2 (1.3%) patients. An overall complication rate of 2.0%, including two major (1.3%) and one minor (0.7%) complications, was observed. No periprocedural mortality was seen. CONCLUSIONS The new GlideLight high-frequency laser sheath allows for a high safety and efficacy in extraction of chronically implanted pacemaker- and implantable cardioverter-defibrillator leads.

Comparative analysis of balloon- versus mechanically-expandable transcatheter heart valves considering landing zone calcification

BACKGROUND The balloon-expandable Sapien 3 (Edwards Lifesciences, Irvine, CA, USA) and the mechanically-expandable Lotus valve (Boston Scientific, Marlborough, MA, USA) are established devices for transcatheter aortic valve implantation. We sought to compare both transcatheter heart valves (THV) under consideration of the extent of THV landing zone calcification. METHODS This retrospective analysis includes consecutive patients with severe aortic stenosis treated with Sapien 3 (S3; n=212) or Lotus (n=61) THV via transfemoral access. Outcome was assessed according to VARC II definitions. Rate of paravalvular leakage (PVL), periprocedural stroke, and permanent pacemaker implantation (PPI) was adjusted for THV landing zone calcification as calculated by multi-slice computed tomography. RESULTS There was no difference in preoperative risk (all results as follows S3 vs. Lotus: STS-PROM 5.9±5.6% vs. 4.8±2.6%, p=0.14), rate of device success (95.3% vs. 95.1%, p=0.67), 30-day mortality (1.9% vs. 4.9%, p=0.16), periprocedural stroke (1.4% vs. 4.9%, p=0.27), and major access site complications (9.4% vs. 9.8%, p=0.93). PPI was more frequent (19.4% vs. 34.4%, p=0.01) and significant PVL was less frequent (≥mild PVL: 17.6% vs. 3.7%, p=0.04) after Lotus implantation. No association was found between landing zone calcification and periprocedural stroke rate (OR 1.19, 95%CI 0.92-1.54, p=0.17) or need for PPI (OR 1.04, 95%CI 0.91-1.18, p=0.57). The extent of landing zone calcification was associated with risk for PVL ≥mild (OR 1.21, 95%CI 1.03-1.42, p=0.02). After adjusting for landing zone calcification risk for PVL ≥mild was lower with the Lotus valve (OR 0.15, 95%CI 0.02-0.54, p=0.01). CONCLUSION Both THVs yield comparable procedural and clinical outcomes except for a higher PPI rate with the Lotus valve, which is independent from the extent of landing zone calcification. The extent of landing zone calcification is associated with an increased risk for PVL for both THV, but is significantly reduced with the Lotus valve.

Navigation of lead extraction—is it possible? Impact of preprocedural electrocardiogram-triggered computed tomography on navigation of lead extraction

OBJECTIVES As the number of transvenous lead extractions continues to increase, preprocedural protocols for this procedure must be assessed. The objective of this study was to determine whether an electrocardiogram (ECG)-triggered computed tomography (Et-CT) with three-dimensional (3D) reconstructions could aid lead extractors in choosing the optimal tools to improve procedural success and avoid complications. METHODS In this study, 31 patients scheduled for transvenous lead extraction underwent a preprocedural Et-CT between January 2016 and May 2017. Both 3D-reconstructions and the two-dimensional files were reviewed for possible lead adhesions, calcifications, migrations or perforations. RESULTS Mean age was 46.7 ± 14.0 years. Seventy-one percent of patients were men, and 29.0% had undergone prior cardiac surgery. Indications for extraction included infection (n = 18, 58.1%), lead dysfunction (n = 8, 25.8%), upgrade (n = 3, 9.7%), severe tricuspid regurgitation (n = 1, 3.2%) and superior vena cava occlusion (n = 1, 3.2%). Eighteen patients had an implantable cardioverter defibrillator (58.1%). Sixty-eight of 70 targeted leads were extracted with a mean of 2.2 leads per patient and an average lead age of 109.3 ± 58.7 months. Et-CT files supported transvenous lead extraction by revealing possible adhesions in 16 patients, 5 perforations and 2 venous occlusions. Lead extraction was performed using the excimer laser, mechanical tools and femoral snares. Complete procedural success was achieved in 93.5% (n = 29) of cases. Clinical success was 100%, and intraoperative mortality was 0%. CONCLUSIONS A preprocedural Et-CT with 3D reconstructions can help to visualize lead alignment and identify abnormalities that may foreshadow procedural difficulties. A preprocedural Et-CT may therefore aid lead extractors in choosing the optimal extraction tool and strategy.

Comparison of latest generation transfemoral self-expandable and balloon-expandable transcatheter heart valves

OBJECTIVES We herein aimed to compare acute 30-day outcomes of latest-generation self-expandable and balloon-expandable transcatheter heart valves. METHODS From 2012 through 2016, 104 consecutive patients (study group, 69.2% female, 81.7 ± 5.5 years, logEuroSCORE I 15.9 ± 9.3%) received transfemoral transcatheter aortic valve implantation using the Symetis ACURATE neo® transcatheter heart valve. A control group of patients after transfemoral transcatheter aortic valve implantation with the Edwards Sapien 3™ transcatheter heart valve was retrieved from our database and matched to the study group. Data were retrospectively analysed according to updated Valve Academic Research Consortium definitions. RESULTS Device success was 94.2% (98 of 104) and 98.1% (102 of 104) in study and control groups, respectively (P = 0.157). All-cause 30-day mortality was 3.9 (4 of 104) vs 0.9% (1 of 104) (P = 0.317). Resultant transvalvular peak/mean gradients and effective orifice area were 14.2 ± 5.7 vs 22.6 ± 6.8 mmHg (P < 0.001)/7.3 ± 2.8 vs 11.8 ± 3.5 mmHg (P < 0.001) and 2.0 ± 0.4 vs 1.7 ± 0.4 cm2 (P = 0.063). Paravalvular leakage ≥moderate was observed in 4.8% (5 of 104) and 1.9% (2 of 104) (P = 0.257). Rate of permanent pacemaker implantation was 10.6% (11 of 104) vs 16.4% (17 of 104) (P = 0.239). CONCLUSIONS Next-generation self-expandable transcatheter heart valves preserve superiority in terms of post-interventional haemodynamics without presenting former drawbacks: rate of postoperative permanent pacemaker implantation and severity of residual paravalvular leakage were similar to balloon-expandable transcatheter heart valves.

TCT-740 Comparison of Procedural, Clinical and Functional Outcome after either Balloon- or Mechanical-expanding Transcatheter Heart Valve Implantation

The analysis aims on comparing outcome after transcatheter aortic valve implantation using either the balloon-expanding Sapien 3 (S3; Edwards Lifesciences, Irvine, USA) or the mechanical-expanding Lotus (Boston Scientific, Marlborough, USA) Transcatheter Heart Valve (THV). Data is derived from the