Long-term impact of a bonus freeze on clinical outcome: Analysis of effective and non-effective bonus freezes in cryoballoon ablation.

PURPOSE: Data on bonus freeze characteristics and their impact on complication rates and long-term clinical outcome are limited. METHODS: Pulmonary vein isolation (PVI) using a 28 mm 2nd-generation cryoballoon (CB) was performed in 169 patients (pts). The isolation temperatures, time to isolation and minimal temperatures of the cryoapplications were documented. RESULTS: The study included 92 pts who received one bonus freeze after PVI in group I and 77 pts who did not receive a bonus freeze in group II. After a mean follow-up time of 19.0±8.6 months in group I and 16.4±7.5 months in group II, 67 of 92 pts (72.8%) and 49 of 75 pts available to follow up (65.3%; p = 0.221) were free of atrial tachyarrhythmia, respectively. Phrenic nerve palsy occurred in 5.4% of the pts in group I (5/92 pts) and 1.3% of the pts in group II (1/77 pts; p = 0.22). Both the mean nadir temperatures of the bonus freezes and mean nadir temperatures of the isolation freezes differed significantly between the recurrent and non-recurrent pts in group I. The predilection sites of the reconduction for both groups were the inferior aspect of the inferior pulmonary veins. CONCLUSION: The impact of a bonus freeze on long-term clinical outcome was not significant for two reasons: 1) The necessity of a bonus freeze was low because the long-term clinical success rate without a bonus freeze was high; and 2) the majority of bonus freezes, especially at the predilection sites, such as the inferior PV, appeared to be ineffective.

REVIVE Trial: Retrograde Delivery of Autologous Bone Marrow in Patients With Heart Failure.

UNLABELLED: Cell therapy is an evolving option for patients with end-stage heart failure and ongoing symptoms despite optimal medical therapy. Our goal was to evaluate retrograde bone marrow cell delivery in patients with either ischemic heart failure (IHF) or nonischemic heart failure (NIHF). This was a prospective randomized, multicenter, open-label study of the safety and feasibility of bone marrow aspirate concentrate (BMAC) infused retrograde into the coronary sinus. Sixty patients were stratified by IHF and NIHF and randomized to receive either BMAC infusion or control (standard heart failure care) in a 4:1 ratio. Accordingly, 24 subjects were randomized to the ischemic BMAC group and 6 to the ischemic control group. Similarly, 24 subjects were randomized to the nonischemic BMAC group and 6 to the nonischemic control group. All 60 patients were successfully enrolled in the study. The treatment groups received BMAC infusion without complications. The left ventricular ejection fraction in the patients receiving BMAC demonstrated significant improvement compared with baseline, from 25.1% at screening to 31.1% at 12 months (p=.007) in the NIHF group and from 26.3% to 31.1% in the IHF group (p=.035). The end-systolic diameter decreased significantly in the nonischemic BMAC group from 55.6 to 50.9 mm (p=.020). Retrograde BMAC delivery is safe. All patients receiving BMAC experienced improvements in left ventricular ejection fraction, but only those with NIHF showed improvements in left ventricular end-systolic diameter and B-type natriuretic peptide. These results provide the basis for a larger clinical trial in HF patients. SIGNIFICANCE: This work is the first prospective randomized clinical trial using high-dose cell therapy delivered via a retrograde coronary sinus infusion in patients with heart failure. This was a multinational, multicenter study, and it is novel, translatable, and scalable. On the basis of this trial and the safety of retrograde coronary sinus infusion, there are three other trials under way using this route of delivery.