Hannes Alessandrini

Histological Findings and Predictors of Cerebral Debris From Transcatheter Aortic Valve Replacement: The ALSTER Experience

Background Histopathological analyses of debris captured by a cerebral protection system during transcatheter aortic valve replacement have been reported, but the origin of the captured debris was not determined and risk factors were not defined. Methods and Results Embolic debris was analyzed from 322 filters used in a dual‐cerebral‐filter protection system implemented during transcatheter aortic valve replacement for 161 patients (mean age 81 years, 82 male [51%], logistic EuroSCORE 19% [interquartile range 12–31%]). The debris capture rate was high, with debris from 97% of all patients (156 of 161). No differences by filter location were found (brachiocephalic trunk 86% [139 of 161], left carotid artery 91% [147 of 161]; adjusted P=0.999). Five prevalent types of debris were identified: thrombus (91%), arterial wall tissue (68%), valve tissue (53%), calcification (46%), and foreign material (30%). Female sex (P=0.0287, odds ratio 1.364, 95% CI 1.032–1.812) and diabetes mellitus (P=0.0116, odds ratio 1.474, 95% CI 1.089–2.001) were significant risk factors for embolic debris. Additional analysis showed significantly more valve tissue in patients with predilation (P=0.0294). Stroke and transient ischemic attack rates were 0.6% each (1 of 161). Conclusion This study showed a high rate of embolic debris consisting of typical anatomic structures known to be altered in patients with aortic stenosis undergoing transcatheter aortic valve replacement. Female patients with diabetes mellitus have increased risk of embolic debris and should be protected by a cerebral protection system during transcatheter aortic valve replacement. Because valve tissue embolizes more often in patients with predilation, procedural planning should consider this finding. Both cerebral arteries (brachiocephalic trunk, left carotid artery) should be protected in the same way.

Repeat MitraClip Therapy for Significant Recurrent Mitral Regurgitation in High Surgical Risk Patients: Impact of Loss of Leaflet Insertion.

OBJECTIVES The goal of this study was to assess procedural details and outcomes of repeat MitraClip therapy. BACKGROUND MitraClip implantation is a safe and efficacious percutaneous approach to treat significant mitral regurgitation (MR). METHODS Of 410 inoperable or high surgical risk patients treated with the MitraClip at our institution, 17 (4.1%) patients, as well as 4 patients initially treated at external institutions, underwent repeat MitraClip procedures. Mean age of the 21 patients (14 men [67%]) was 77 years; 15 patients (71%) had functional MR. RESULTS Repeat procedures performed at a median of 6.3 months (range 0.7 to 34 months) after the index intervention were successful (discharge MR grade ≤2+) in 13 patients (62%), with a pronounced difference in success rate observed between the 13 patients with adequate leaflet insertion at the time of the repeat intervention and the 8 patients in whom loss of leaflet insertion (LLI) (leaflet tear/perforation or partial clip detachment) was present (11 of 13 [85%] vs. 2 of 8 [25%], respectively). The 21 patients were followed for a median of 8.5 (interquartile range: 2.3 to 18.6) months; 13 patients (62%), 8 with adequate leaflet insertion and 5 with LLI, died during follow-up. CONCLUSIONS Repeat MitraClip intervention for significant recurrent MR appears to be a viable therapeutic approach in patients in whom leaflet insertion into the MitraClip is not compromised. LLI is strongly associated with repeat procedural failure.

Transcatheter implantation of aortic valve prostheses into degenerated mitral valve bioprostheses and failed annuloplasty rings: outcomes according to access route and Mitral Valve Academic Research Consortium (MVARC) criteria.

AIMS The study sought to assess outcomes of transcatheter mitral valve-in-valve implantation (TMVIV) for degenerated bioprostheses and transcatheter mitral valve-in-ring implantation (TMVIR) for failed annuloplasty rings according to access route and the Mitral Valve Academic Research Consortium (MVARC) criteria. METHODS AND RESULTS Twenty-four patients (72±13 years; eight men [33%]) underwent TMVIV (n=14) or TMVIR (n=10) for mitral regurgitation (MR; n=17) or stenosis (n=7) using balloon-expandable bioprostheses. Transapical (TA) access was chosen in 13, and transseptal (TS) access in 11 patients. MVARC technical success, device success and procedural success were 95.8%, 41.7% and 33.3%, respectively, with no differences between access routes. Cardiac output (CO) increased significantly by 1.1±0.8 l/min in TS patients, but not in TA patients (ΔCO=0.0±0.5 l/min; p=0.0051). Overall three-year survival was estimated at 57.6% (95% confidence interval: 33.9-81.3; TA 35.5% [5.2-65.9]; TS 90.9% [73.9-100]). Survival up to four years according to vascular access showed a clear benefit in patients treated transseptally (p=0.045). CONCLUSIONS Regardless of the access route, TMVIV/TMVIR was associated with high technical success yet impaired device success. In the long term, TA access had a significant adverse impact on survival.

Histology of debris captured by a cerebral protection system during transcatheter valve-in-valve implantation

Objective Histological analyses of debris captured by a cerebral protection system (CPS) during transcatheter valve-in-valve (VIV) procedures have not been reported. Methods Fifteen consecutive patients with stenotic aortic (n=13) or mitral (n=2) surgical or transcatheter bioprostheses were treated with implantation of a transcatheter heart valve (THV) in the presence of a dual-filter CPS. Mean patient age was 75 years; mean logistic EuroSCORE was 31%. Filters were collected and histological assessment of debris was performed. Patients were followed clinically until discharge. Results Debris captured by either or both filters was detected in all patients. Acute thrombus was the most common type of debris, found in all patients, followed in frequency by arterial wall tissue (n=12 patients (80%)), calcification (n=11 (73%)) and valve tissue (n=9 (60%)). Less frequently found were organised thrombus (n=5 (30%)), foreign material (n=4 (27%)) and myocardium (n=2 (13%)). A median of 123 debris particles per patient was detected, with a trend towards a greater median number of particles collected in proximal filters (78 vs 39, p=0.065). The average maximum particle diameter was 88 (range 56–175) µm, with a median of 20 particles ≥150 µm. No stroke or transient ischaemic attack (TIA) had occurred by the time of discharge (mean 8 days). Conclusions Transcatheter VIV procedures were associated with the release of particulate debris into the cerebral circulation in all patients. The type of debris suggests that debris originates predominantly from arterial and valvular passage of the THV.

MitraClip® via direct right atrial access in case of a missing inferior vena cava.

The presence of mitral regurgitation (MR) in patients with heart failure represents an independent predictor of mortality. Until now, the standard therapy for severe MR has been cardiac surgery in order to perform mitral valve replacement or mitral valve repair. With the introduction of the MitraClip® system (Abbott Vascular - Structural Heart, Menlo Park, CA, USA) in 2008, there is now an alternative percutaneous treatment option available for high-risk patients. We report on an 84-year-old male patient who was admitted to the emergency room with increasing shortness of breath due to severe functional MR, at stage NYHA III. In the following days the patient developed cardiogenic shock due to failure of the diuretic medication. The case first described here demonstrates an alternative transseptal route of access via a direct atrial puncture of the RA in a patient with absent inferior vena cava. This approach was successfully used to perform a MitraClip® procedure in this patient with functional MR and cardiogenic shock. It was possible to treat mitral regurgitation and the consecutive cardiogenic shock by implanting two MitraClips®.

Redo TAVI: initial experience at two German centres.

AIMS The aim of this study was to assess the feasibility and early outcomes of transcatheter aortic valve implantation (TAVI) in dysfunctional TAVI prostheses (redo TAVI). METHODS AND RESULTS Nineteen redo TAVI procedures were performed between October 2011 and November 2015 at two German centres. Mean age was 78 years, 13 (68%) were male, and the mean logistic EuroSCORE was 32%. Median time elapsed since index TAVI was 644 days (interquartile range 191-1,831). Failure mode of the index TAVI prosthesis was regurgitation (AR) in 16 patients (n=12 paravalvular AR, n=3 combined paravalvular/valvular AR, n=1 valvular AR) and stenosis in three patients. Device success was achieved in 89% (17/19). Median invasive post-interventional transprosthetic gradient was 3.0 mmHg. No severe prosthesis-patient mismatch (PPM) was observed. At one year, mean pressure gradient was 9±1.2 mmHg and no relevant PPM was documented in 90% of the cases. All-cause mortality at 30 days and one year was 11% and 33% (6/18, five non-cardiac deaths), respectively. Mean follow-up time was 404 days. CONCLUSIONS Redo TAVI appears to be feasible. Paravalvular regurgitation was the most common indication for a redo procedure. Rates of device success were high with low post-interventional gradients and no severe PPM. Good functional status of the prosthesis was maintained after 12 months, but mortality rates were high in this small comorbid patient population.

Is Surgical or Catheter Based Interventions an Option after an Unsuccessful Mitral Clip

The objective of this study was to assess the results of catheter-based and surgical reinterventions in primary mitral regurgitation after failed MitraClip therapy. We report on 21 consecutive symptomatic patients with primary mitral regurgitation (median age 78 years) who underwent either repeat MitraClip therapy (n = 7) or mitral valve surgery (n = 14) after failure of the index procedure with 1-2 MitraClip implantations. At the time of reinterventions, 193 (interquartile range [IQR]: 32-622) days after the index procedure, patients had recurrent or persistent grade 3 mitral regurgitation. Early mortality at 30 days was 4.8%. Cardiac-related survival at 2 years was 85.4% (4 cardiac and 4 noncardiac deaths). Three of 7 patients with percutaneous reintervention were converted to surgery at 34, 52, and 56 days because repeat MitraClip therapy was ineffective because of pre-existing clip detachment or leaflet tear. Final therapy was biological mitral valve replacement in 14 of 21 patients (66.7%); 4 were treated with percutaneous repeat MitraClip repair (19%), and in 3 patients, surgical repairs were performed (14.3%). At follow-up with a median of 708 days, New York Heart Association class had improved significantly to class 2 (IQR: 1.0-2.5) (P = 0.0004), and the left ventricular end-diastolic diameter had decreased from 56 (IQR: 52-59) mm to 51 (48-58) mm (P = 0.0378), respectively. Recurrence of significant mitral regurgitation was absent in all but 1 patient with unsuccessful repeat MitraClip therapy who was deemed inoperable. Our data show that both repeat MitraClip and also mitral valve surgery are feasible and safe alternatives in patients without an excessively increased perioperative risk. We conclude that whenever leaflet insertion is not compromised, repeat catheter-based repair is a reasonable redo concept; in the remaining cases, surgery should be offered to the patient.

How should I treat a rupture of the interatrial septum with haemodynamically relevant right-to-left shunt during MitraClip implantation?

*Corresponding author: Department of Cardiology, Asklepios Klinik St. Georg, Lohmuehlenstrasse 5, 20099 Hamburg, Germany. E-mail: tob.schmidt@asklepios.com PRESENTATION OF THE CASE A 61-year-old male patient with severe functional mitral regurgitation (MR) and severe coronary artery disease with high surgical risk for CABG with combined surgical mitral valve repair or replacement (logistic EuroSCORE 27.6%, EuroSCORE II 11.6%) underwent a two-step strategy (due to the institutional Heart Team decision) with coronary artery bypass grafting (CABG) (onpump beating heart) first, follow-up monitoring of the MR, and MitraClip® (Abbott Vascular Inc., Santa Clara, CA, USA) implantation as a second step if MR did not improve sufficiently. Three months after CABG, the patient presented at our clinic with dyspnoea of New York Heart Association functional Class IV. Echocardiography still showed severe functional MR. Right heart function was slightly reduced (tricuspid annular plane systolic excursion 12 mm). For the MitraClip procedure, the patient was mechanically ventilated and was under general anaesthesia. Haemodynamic measurements showed an increased right atrial pressure of 23 mmHg, while left atrial pressure was only 12 mmHg (V-wave 18 mmHg). Cardiac output was 2.2 l/min, cardiac index 1.2 l/min/m2, pulmonary wedge pressure 27 mmHg (V-wave 33 mmHg), pulmonary artery pressure 40/19 (mean 28) mmHg. Before transseptal puncture, bulging of the atrial septum into the left atrium was noticed (Figure 1). Transseptal puncture at 4.6 cm above the annulus as well as insertion of the steerable guide catheter over an AmplatzTM superstiff wire, 7 cm J-tip (Boston Scientific, Marlborough, MA, USA) was performed without any problems. During positioning of the MitraClip, height of the clip delivery system was lost due to rupture of the atrial septum (Figure 2) so that positioning was complicated, CASE SUMMARY

Acute Hemodynamic Changes after Mitraclip Implantation Comparing Patients with Degenerative and Functional Mitral Regurgitation

ABSTRACT Background:MitraClip (MC) therapy is a percutaneous treatment option for surgical high-risk patients with both degenerative (DMR) and functional mitral regurgitation (FMR). We compared the acute hemodynamic outcomes of MC therapy in DMR and FMR patients. Methods:A total of 339 successfully treated patients (77 ± 9 years; 215 men [63%]; 129 DMR [38%], 210 FMR [62%]; LV ejection fraction 40 ± 17%) were hemodynamically assessed pre- and post-MC. Results:FMR patients had significantly higher pre- and post-MC filling pressures, as well as higher pulmonary capillary wedge and mean pulmonary artery pressures, than DMR patients, but the increase or decrease in these variables did not differ significantly between etiologies. Cardiac output increased significantly in both groups (DMR: 4.1–4.9 l/min; FMR: 4.1–5.1 l/min; both p < 0.0001); the increase was statistically not different between etiologies (DMR: 0.8 ± 1.1 l/min; FMR: 1.0 ± 1.1 l/min; p = 0.06). With heart rate constant pre- and post-MC, significant increases were also observed in forward stroke volume (DMR: 70–84 ml; FMR: 70–86 ml; both p < 0.0001). The mean left atrial v-wave was statistically not different between etiologies at baseline and decreased significantly after MC (DMR: 26–17 mmHg; FMR: 27–21 mmHg; both p < 0.0001). Conclusion:Successful MC therapy results acutely in marked increases in cardiac output and forward stroke volume, and a significant decrease in the left atrial v-wave, in both DMR and FMR patients. Our results attest to the beneficial effect of percutaneous mitral valve repair, particularly in the latter patients with generally poorer baseline health.

TCT-653 Histology of debris captured by a cerebral protection system during transcatheter valve-in-valve implantation

Zbigniew Chmielak, Wojciech Wojakowski, Radosław Parma, Andrzej Ochała, Michał Lelek, Marek Grygier, Anna Olasi nska-Wi sniewska, Aleksander Araszkiewicz, Maciej Lesiak, Dariusz Jagielak, Dariusz Cie cwierz, Radosław Wilimski, Dominika Puchta, Katarzyna Paczwa, Krzysztof Filipiak, Grzegorz Opolski First Department of Cardiology, Medical University of Warsaw, Warsaw, Poland; CSK AM, Warsaw, Poland; First Department of Cardiology, Medical University of Warsaw; Medical University of Warsaw, Warsaw, Poland; First Department of Cardiology, Medical University of Warsaw; Institute of Cardiology; Institute of Cardiology, Warsaw, Poland; Instytut Kardiologii Prymasa Tysiaclecia, Warsaw, Poland; The Prince Charles Hospital; Medical University of Silesia; Medical University of Silesia; Medical University of Silesia; Poznan University of Medical Sciences, Zlotniki, Poland; Medical University of Pozna n; Poznan University of Medical Sciences, Poznan, Poland; University Hospital, Poznan, Poland; Uniwersyteckie Centrum Kliniczne, Gdansk, Poland; Medical University of Gda nsk; Department of Cardiac Surgery, Medical University of Warsaw; First Department of Cardiology, Medical University of Warsaw; First Department of Cardiology, Medical University of Warsaw; Hannover Medical School; Dept. of Cardiology, Medical University of Warsaw, Warsaw, Poland