Giuliano Chizzola

Excimer Laser LEsion Modification to Expand Non-dilatable sTents: The ELLEMENT Registry

BACKGROUND/OBJECTIVES Stent underexpansion is a risk factor for in-stent restenosis and stent thrombosis. Existing techniques to optimize stent expansion are sometimes ineffective. The aim of this study was to evaluate the effectiveness and feasibility of Excimer Laser Coronary Angioplasty (ELCA) in improving stent expansion when high-pressure non-compliant balloon inflation was ineffective. METHODS AND RESULTS ECLA ablation was performed at high energy during contrast injection and only within the underexpanded stent. The primary endpoint of successful laser dilatation was defined as an increase of at least 1mm(2) in minimal stent cross-sectional area (MSA) on IVUS or an increase of at least 20% in minimal stent diameter (MSD) by QCA, following redilatation with the same non-compliant balloon that had been unsuccessful prior to ELCA. Secondary endpoints were cardiac death, myocardial infarction (MI) and target lesion revascularization. Between June 2009 and November 2011, 28 patients with an underexpanded stent despite high-pressure balloon inflation were included. The mean laser catheter size was 1.2±0.4 (range 0.9-2.0mm) and a mean of 62±12mJ/mm(2) at 62±21hertz were required for optimal expansion. Laser-assisted stent dilatation was successful in 27 cases (96.4%), with an improvement in MSD by QCA (1.6±0.6mm at baseline to 2.6±0.6mm post-procedure) and MSA by IVUS (3.5±1.1mm(2) to 7.1±1.9mm(2)). Periprocedural MI occurred in 7.1%, transient slow-flow in 3.6% and ST elevation in 3.6%. During follow-up, there were no MIs, there was 1 cardiac-death, and TLR occurred in 6.7%. CONCLUSIONS The ELLEMENT study confirms the feasibility of ELCA with contrast injection to improve stent underexpansion in undilatable stented lesions.

Direct transcatheter aortic valve implantation with self-expandable bioprosthesis: Feasibility and safety ☆

BACKGROUND Balloon valvuloplasty has been considered a mandatory step of the transcatheter aortic valve implantation (TAVI), although it is not without risk. The aim of this work was to evaluate the feasibility and safety of TAVI performed without pre-dilation (direct TAVI) of the stenosed aortic valve. MATERIAL AND METHODS Between June 2012 and June 2013, 55 consecutive TAVI performed without pre-dilation at our institution using the self-expandable CoreValve prosthesis (Medtronic, Minneapolis, MN) were analyzed and compared with 45 pre-dilated TAVI performed the previous year. Inclusion criteria were a symptomatic and severe aortic stenosis. Exclusion criteria were defined as presence of pure aortic regurgitation, degenerated surgical bioprosthesis or bicuspid aortic valve and prior procedure of balloon aortic valvuloplasty performed as a bridge to TAVI. RESULTS High-burden calcification in the device landing zone, assessed by CT scan, was found in most of the patients. The valve size implanted was similar in both groups. Device success was higher in direct TAVI (85%vs.64%,p=0.014), mostly driven by a significant lower incidence of paravalvular leak (PVL≥2;9%vs.33%,p=0.02). Safety combined end point at 30 days was similar in both groups. CONCLUSION Compared to TAVI with pre-dilation, direct TAVI is feasible regardless of the presence of bulky calcified aortic valve and the valve size implanted. Device success was higher in direct TAVI, mostly driven by a lower incidence of paravalvular leak. Safety at 30 days was similar in two groups.

Early outcome of high energy Laser (Excimer) facilitated coronary angioplasty ON hARD and complex calcified and balloOn-resistant coronary lesions: LEONARDO Study

AIM An innovative xenon-chlorine (excimer) pulsed laser catheter (ELCA X80) has been recently used for the treatment of complex coronary lesions, as calcified stenosis, chronic total occlusions and non-compliant plaques. Such complex lesions are difficult to adequately treat with balloon angioplasty and/or intracoronary stenting. The aim of this study was to examine the acute outcome of this approach on a cohort of patients with coronary lesions. METHODS AND RESULTS Eighty patients with 100 lesions were enrolled through four centers, and excimer laser coronary angioplasty was performed on 96 lesions (96%). Safety and effectiveness data were compared between patients treated with standard laser therapy and those treated with increased laser therapy. Laser success was obtained in 90 lesions (93.7%), procedural success was reached in 88 lesions (91.7%), and clinical success in was obtained in 87 lesions (90.6%). There was no perforation, major side branch occlusion, spasm, no-reflow phenomenon, dissection nor acute vessel closure. Increased laser parameters were used successfully for 49 resistant lesions without complications. CONCLUSIONS This study suggests that laser-facilitated coronary angioplasty is a simple, safe and effective device for the management of complex coronary lesions. Furthermore, higher laser energy levels delivered by this catheter improved the device performance without increasing complications.

Mitraclip therapy in patients with functional mitral regurgitation and missing leaflet coaptation: is it still an exclusion criterion?

The aim of this study was to investigate the feasibility, safety, and efficacy of Mitraclip therapy in patients with functional mitral regurgitation (MR) and missing leaflet coaptation (MLC).

The combined use of Drug-eluting balloon and Excimer laser for coronary artery Restenosis In-Stent Treatment: The DERIST study.

AIM Stents reduce angiographic restenosis in comparison with balloon angioplasty. The rate of in-stent restenosis (ISR), although less frequent than post-angioplasty restenosis, is becoming increasingly prevalent due to the recent exponential increase in the use of intracoronary stents. The aim of this study is to evaluate angiographic and clinical outcomes of PTCA in combination with the use of excimer laser coronary angioplasty (ELCA) and drug-eluting balloon (DEB) in treatment of in-stent restenosis (ISR). METHODS AND RESULTS This multi-centric case-control study evaluated angiographic and clinical outcomes of PTCA with excimer laser coronary angioplasty (ELCA) and drug-eluting balloon (DEB) in 80 patients with in-stent restenosis (ISR). All patients underwent nine months of clinical and a coronary angiography follow-up. This study showed clinical and angiographic long-term success in the 91% of the patients. The incidence of myocardial infarctions and deaths was lower than the rate after plain balloon angioplasty within the stent. CONCLUSIONS This study showed that excimer laser coronary angioplasty (ELCA) and drug-eluting balloon (DEB) may be an alternative treatment for in-stent restenosis (ISR).

Role of different vascular approaches on transcatheter aortic valve implantation outcome: a single-center study.

Objective To compare different vascular approaches on clinical outcome of patients undergoing transcatheter aortic valve implantation (TAVI) with self-expandable bioprosthesis. Methods We included all the patients undergoing CoreValve implantation at our institute between September 2007 and March 2014. They were divided into four groups based on the vascular approach: percutaneous transfemoral (pTF), cut-down transfemoral (cTF), transaxillary (TAx) and transaortic (TAo). Clinical outcomes were evaluated according to Valve Academic Research Consortium-2 recommendations. Results Out of 322 consecutive patients, 170 (53%) underwent pTF, 76 (23%) cTF, 32 (10%) TAx and 44 (14%) TAo approach. Although the TAx and TAo patients had a higher risk profile, they had a similar outcome compared with the pTF and cTF groups; in particular, there were no differences regarding cardiovascular and all-cause mortality at 30 days, 1 and 2 years, as well as stroke, myocardial infarction, bleeding, major vascular complications, permanent pacemaker implantation and acute kidney injury rates. The observed device success rate was higher in the TAo than in the other approaches (88.6 versus 65.9, 68.7 and 76.3% in the pTF, cTF and TAx groups, respectively; P = 0.019). No differences occurred regarding 30-day early safety and 1-year clinical efficacy across the four groups. Fluoroscopy time, amount of contrast medium used and minor vascular complications were significantly higher in pTF patients, as well as in-hospital stay in the TAo group. Atrial fibrillation and prosthetic valve regurgitation, but not the vascular approach, were independent predictors of all-cause mortality. Conclusion A more invasive vascular approach, for CoreValve implantation, even in higher risk patients, does not affect early-term, mid-term and long-term outcomes.

Percutaneous edge-to-edge mitral valve repair for the treatment of acute mitral regurgitation complicating myocardial infarction: A single centre experience

BACKGROUND Limited evidence is available about MitraClip therapy in patients with acute mitral regurgitation (MR) complicating myocardial infarction (MI). METHODS AND RESULTS Among 80 consecutive patients undergoing MitraClip treatment, 5 (6.3%) had been admitted for acute MI complicated by severe MR. Mean age was 73±6years and 3 were males. At the time of admission they were in cardiogenic shock (80%) or pulmonary oedema (20%), with severe MR, left ventricular dysfunction and pulmonary hypertension. The indication to MitraClip treatment was based on severe hemodynamic instability with dependence on intravenous therapy and mechanical supports despite percutaneous coronary revascularization and on high surgical risk of 27.1±13% and 10.2±6% using Euroscore II and STS score respectively. MitraClip procedure was performed at 53±33days from admission. One or two clips were employed in 2 and 3 patients respectively. Procedural success (MR≤2+) was achieved in all patients without complications and with successful weaning from mechanical supports and intravenous drugs in all but one patient who underwent left ventricular assist device implantation at 60days from MitraClip procedure. MR recurrence occurred at 30-day follow-up in one patient who had concomitant aortic regurgitation. One patient died during follow-up for non-cardiovascular cause. However, recovery of hemodynamic balance with significant and persistent pulmonary pressure reduction and functional status improvement up to 2-year follow-up was observed in most of the patients. CONCLUSIONS Critical patients with acute ischemic MR post-MI with persistence of hemodynamic instability after coronary revascularization may benefit from MitraClip therapy acutely with favourable long-term follow-up results.

Drug-eluting stent use after coronary atherectomy: results from a multicentre experience – The ROTALINK I study

Aims Until now, there is no medium- to long-term clinical evidence of the best treatment after rotational atherectomy. Methods From the databases of seven high-volume centres, years 2005–2010, we retrospectively analysed the long-term outcome of patients who had undergone rotational atherectomy followed by plain-balloon angioplasty or implantation of drug-eluting stent (DES) or bare metal stent (BMS). Primary endpoint was the incidence of major adverse cardiovascular events (MACE: death, myocardial infarction, target-lesion-revascularization) at longest available follow-up. Results In this registry, we enrolled 1397 patients with 1605 lesions, followed for 28.4 ± 21 months. DES-treated patients were more frequently diabetic, had more lesions treated and received a higher number of stents. In-hospital MACEs were significantly higher in DES patients (7.6 vs. 2.6 vs. 2.9%, respectively, P = 0.0001 for both), mainly due to a higher incidence of myocardial infarction (6.4 vs. 1.2 vs. 2.1%, P = 0.0001). The 2-year follow-up showed a significantly lower incidence of MACE in DES patients (15.1 vs. 24.2 vs. 20.8%, P = 0.001 for both), driven by a lower incidence of target-lesion revascularization (8 vs. 14.6 vs. 13.9%, P = 0.002). Myocardial infarction rate was lower in the DES group as well (0.4 vs. 3.1% in BMS, P = 0.001). At multivariate analysis, BMS implantation and balloon angioplasty were independent predictors of long-term MACE. DES implantation was associated with a lower risk of long-term myocardial infarction [hazard ratio 0.15, 95% confidence interval (95% CI) 0.04–0.67] and target-lesion revascularization (hazard ratio 0.42, 95% CI 0.21–0.82). Male sex and DES use were independent predictors of the absence of MACE. Conclusion After rotational atherectomy, DES implantation appears to be a preferable strategy, as it is associated with lower long-term MACE, despite an unexpected increase in periprocedural myocardial infarction.

Effects of drug-eluting stents after rotational atherectomy: evidence from a multicenter experience.

Aims Rotational atherectomy is used as an adjuvant tool for percutaneous coronary interventions, especially in case of highly calcific atherosclerotic plaques. Subsequent drug-eluting stent (DES) implantation is common; however, there is a paucity of clinical evidence to support this practice. Methods From the databases of four high-volume Italian centers, we analyzed the angiographic outcome of patients who underwent rotational atherectomy in native coronary vessels followed by DES or bare metal stent (BMS) implantation. Primary study endpoint was late lumen loss at the longest available follow-up. Other analyses consisted of the evaluation of in-stent percentage diameter stenosis, binary restenosis, major adverse cardiovascular events, and stent thrombosis at angiographic control. Results Between 2006 and 2011, 672 patients with 734 lesions treated had complete angiographic follow-up and were enrolled into this study; 385 lesions were treated with DES and 349 with BMS. The average follow-up length was 9 ± 5 months. Only a few significant differences regarding baseline clinical and angiographic characteristics were observed. Late lumen loss result significantly improved after DES implantation in comparison with BMS (0.54 ± 0.79 vs. 1.01 ± 1.13; P = 0.001), as well as in-stent percentage diameter stenosis (P = 0.01) and binary restenosis (P = 0.007). Major adverse cardiovascular events did not differ significantly, but showed an improved trend in the DES group, driven by a significantly lower target lesion revascularization (6.9 vs. 11.6%; P = 0.04). Conclusion In a cohort of patients treated with rotational atherectomy and with complete angiographic follow-up, DES implantation is associated with improved late lumen loss over BMS. However, the DES effect in terms of angiographic endpoints seems mitigated if compared to previous studies.

Difficult Cases and Complications from Catheterization Laboratory: MitraClip Therapy in a Patient with Lack of Leaflet Coaptation

In patients with functional mitral regurgitation (MR) due to extreme annulus and/or left ventricle dilation, the valve geometry features required for MitraClip implantation, in particular the coaptation length ≥2 mm and the coaptation depth <11 mm, could be missing. We report the case of a 43-year-old patient with severe ischemic mitral regurgitation and lack of leaflet coaptation mainly due to posterior mitral leaflet retraction, showing step by step the possible pharmacological and mechanical methods to modify the mitral valve apparatus allowing the leaflet grasping using MitraClip device.