Real-world data of patients affected by advanced heart failure treated with implantable cardioverter defibrillator and left ventricular assist device: Results of a multicenter observational study.

BACKGROUND: Left ventricular assist device (L-VAD) implantation is increasingly used in patients with heart failure (HF) and most patients also have an implantable cardioverter defibrillator (ICD). Limited data are available on the incidence of ICD therapies and complications in this special setting. The aim of this study was to analyze the real-world incidence and predictors of ICD therapies, complications and interactions between ICD and L-VAD. METHODS: We conducted a multicenter retrospective observational study in patients with advanced HF implanted with ICD and a continuous-flow L-VAD, followed-up in five advanced HF centers in Northern Italy. RESULTS: A total of 234 patients (89.7% male, median age 59, 48.3% with ischemic etiology) were enrolled. After a median follow-up of 21 months, 66 patients (28.2%) experienced an appropriate ICD therapy, 22 patients (9.4%) an inappropriate ICD therapy, and 17 patients (7.3%) suffered from an interaction between ICD and L-VAD. The composite outcome of all ICD-related complications was reported in 41 patients (17.5%), and 121 (51.7%) experienced an L-VAD-related complication. At multivariable analysis, an active ventricular tachycardia (VT) zone and a prior ICD generator replacement were independent predictors of ICD therapies and of total ICD-related complications, respectively. CONCLUSIONS: Real-world patients with both L-VAD and ICD experience a high rate of ICD therapies and complications. Our findings suggest the importance of tailoring device programming in order to minimize the incidence of unnecessary ICD therapies, thus sparing the need for ICD generator replacement, a procedure associated to a high risk of complications.

Response to acute vasodilator challenge and haemodynamic modifications after MitraClip in patients with functional mitral regurgitation and pulmonary hypertension.

The effectiveness of transcatheter edge-to-edge repair (TEER) in patients with functional mitral regurgitation (FMR) and pulmonary hypertension (PH) is still debated and pre-procedural predictors of haemodynamic improvement after TEER in this setting are currently unknown. We investigated whether normalization of pulmonary artery wedge pressure (PAWP) in response to sodium nitroprusside (SNP) during baseline right heart catheterization might be predictive of a favourable haemodynamic response to MitraClip in patients with FMR and PH. Among 22 patients enrolled, 13 had a positive response to SNP (responders), nine were non-responders. At 6-months follow-up, responders showed a 33% reduction in PAWP and a 25% reduction in mean pulmonary artery pressure (PAP) (P = 0.002 and 0.004, respectively); no significant change occurred in non-responders. In patients with FMR and PH, pre-procedural vasodilator challenge with SNP may help define patients who may have haemodynamic improvement after TEER.

Combined Transcatheter Treatment of Severe Aortic Valve Stenosis and Infrarenal Abdominal Aortic Aneurysm in Increased Surgical Risk Patients.

The prevalence of combined severe aortic stenosis and abdominal aortic aneurysm is increasing with the aging of the population. Both conditions are associated with adverse outcome if not adequately managed. The choice of the optimal treatment of these patients is challenging and no clear recommendations are available. We report 2 cases of patients with concomitant severe symptomatic aortic stenosis and infrarenal abdominal aortic aneurysm successfully treated with combined transfemoral transcatheter aortic valve implantation (TAVI) and endovascular aortic aneurysm repair (EVAR). The reported cases demonstrate the versatility of transcatheter techniques and suggest that, in carefully selected patients, the combined procedure of TAVI plus EVAR, if performed by multidisciplinary expert operators, is safe and effective.

MitraClip procedure as 'bridge to list', the ultimate therapeutic option for end-stage heart failure patients not eligible for heart transplantation due to severe pulmonary hypertension.

Patients with end-stage heart failure (HF), pulmonary hypertension and elevated pulmonary vascular resistance (PVR) despite medical therapy are not eligible for heart transplantation (HTx). In this 'proof of concept' case series, we demonstrate the feasibility and efficacy of the MitraClip procedure as 'bridge to list' in end-stage HF patients not eligible for HTx. In fact, in the three patients reported, who were initially excluded from the HTx list because of elevated PVR, the MitraClip procedure was followed by a sustained improvement of PVR, allowing the patients' risk to be reclassified, and they were then considered eligible for HTx.

[Valve-in-valve treatment of a degenerated supra-annular stentless bioprosthesis using a balloon-expandable transcatheter valve in a patient at high risk for coronary occlusion]. / Trattamento valve-in-valve con protesi balloon-expandable di bioprotesi chirurgica stentless sovra-anulare degenerata con alto rischio di occlusione coronarica.

Transcatheter valve-in-valve treatment of degenerated supra-annular stentless bioprostheses may be challenging and associated with a high risk of coronary occlusion. Preprocedural imaging evaluation is a key step to assess feasibility and to minimize or prevent coronary occlusion. We report the case of a degenerated Freedom Solo valve, treated with a balloon-expandable valve and a previously deflated stent positioned at the level of both coronary ostia. The procedure was successful but stent inflation at the right coronary ostium was required due to slow flow that occurred after valve implantation.

Percutaneous mitral valve repair: The last chance for symptoms improvement in advanced refractory chronic heart failure?

BACKGROUND: The role of percutaneous mitral valve repair (PMVR) in patients with end-stage heart failure (HF) and functional mitral regurgitation (FMR) is unclear. METHODS: Seventy-five consecutive patients with FMR grade≥3+ and severe HF symptoms despite optimal medical therapy and resynchronization therapy underwent PMVR with the MitraClip system (Abbott, Abbott Park, IL, USA) at 3 centers. Clinical evaluation, echocardiography and pro-BNP measurement were performed at baseline and at 6-month. RESULTS: Mean age was 67±11years, logistic EuroSCORE=23±18%, left ventricle ejection fraction (LVEF) 30±9%. In 6 patients (8%) PMVR was performed as a bridge to heart transplant; many patients were dependent from iv diuretics and/or inotropes. Rate of serious adverse in-hospital events was 1.3% (1 patient who died after conversion to cardiac surgery). Sixty-three patients (84%) were discharged with MR≤2+. At 6-month, 4 patients died (5%), 80% had MR≤2+ and 75% were in New York Heart Association class ≤II. Median pro-BNP decreased from 4395pg/ml to 2594pg/ml (p=0.04). There were no significant changes in LV end-diastolic volume (222±75ml vs. 217±79, p=0.19), end-systolic volume (LVESV, 154±66ml vs. 156±69, p=0.54) and LVEF (30±9% vs. 30±12%, p=0.86). Significant reverse remodeling (reduction of LVESV≥10%) was observed in 25%, without apparent association with baseline characteristics. The number of hospitalizations for HF in comparison with the 6months before PMVR were reduced from 1.1±0.8 to 0.3±0.6 (p<0.001). CONCLUSIONS: In extreme risk HF patients with FMR, PMVR improved symptoms and reduced re-hospitalization and pro-BNP levels at 6months, despite the lack of LV reverse remodeling.

The pathologic basis of recovery.

More patients with end-stage heart failure are now being supported by left ventricular assist devices (LVAD) as a bridge to heart transplant. The LVAD unloads the failing heart and modifies the myocardial structure, with regression of left ventricular hypertrophy. The regression of hypertrophy has been reported histomorphologically in paired samples of myocardial tissues obtained from the same patient at the time of LVAD implantation and the heart excised at transplant. The understanding of the mechanisms of recovery may contribute to strategic development for LVAD weaning and the use of LVAD as a destination therapy.

Results of the European clinical trial of Arrow CorAide left ventricular assist system.

The aim of this study was to evaluate the safety and performance of the Arrow CorAide left ventricular assist system (LVAS) (Arrow International, Reading, PA, USA), a continuous-flow left ventricular assist device, as bridge to transplantation or recovery as well as destination therapy in patients with New York Heart Association (NYHA) class IV heart failure. Twenty-one patients were implanted with the CorAide LVAS between February 2005 and February 2006 in a prospective, multicenter, nonrandomized trial. Seventeen patients (81%) survived to >180 days or to transplantation. The cumulative time on device was 16.58 patient years (range 23-796 days, median 192 days). No intraoperative technical issues were observed at the time of implantation. Of the 21 implants, nine patients died on device, two were converted to other devices, and 10 were transplanted. Three patient deaths were attributed to pump polymer coating delamination. Postmortem device inspection determined delamination of the polymer coating on the pump's internal surface to be the cause of the late hemolysis and sudden fatal pump stops. No embolic or driveline infection event was recorded. The automatic flow control algorithm functioned reliably throughout the trial. Primary performance trial endpoint was achieved with 81% survival to 180 days or transplantation. Delamination of the polymer coating on the internal surface of the pump with resultant hemolysis and pump stops was the sole major device event in this trial. Elimination of the polymer coating and replacement with an amorphous carbon coating has resolved this in preclinical testing, prior to initiation of further clinical testing of this device.

Initial results of clinical trial with a new left ventricular assist device (LVAD) providing synchronous pulsatile flow.

OBJECTIVES: A multicentric European Clinical Study is ongoing to evaluate safety and efficacy of a new pulsatile implantable LVAD (BestBeat), smaller and lighter than similar devices, capable of providing synchronous and counterpulsating flow with respect to the LV of end-stage heart failure patients. Preliminary clinical results are reported. METHODS: The new BestBeat LVAD was used, consisting of an implantable pulsatile blood pump, electromechanically driven by a ball screw mechanism, and a wearable electronic controller and power sources. The clinical trial was conducted at 5 european centers. Adult patients affected by CHF in NYHA Class IV despite optimized medical treatment were enrolled. The primary study endpoint was survival at 90 days. Further study endpoints were maintenance of adequate LVAD pump flow and a minimum rate of adverse events during support. RESULTS: As of June 2008, 6 patients received the implant. Cumulative support time was 3.7 years, median support time 176 days. All patients who completed the study survived except for one, who died after 48 days, due to combined infection and cerebrovascular accident. Another two patients died: one from intracranial bleeding 113 days after implant, and one from septic shock after 123 days. Hemodynamic improvement with CI>2.0 l/min/m2 and recovery of end-organ function expressed by consistent improvement of BUN, creatinine and bilirubin were reached in all patients. No device failure was observed. There was no bleeding requiring re-exploration, no hemolysis and only two device-related infections (both in one patient). Neurologic events were reported, the most serious ones occurring in patients with pre-implant respiratory and kidney failure. Three patients were discharged home. Two patients were successfully transplanted, one after 6 months and one after 13 months on device. CONCLUSIONS: Good performance and efficacy of the device were observed; the endpoints of the study were achieved, and its safety was consistent with expectations. The ongoing study will allow further conclusions to be drawn.